Search results from the Australian New Zealand Clinical Trials Registry

Your query returned 54 records. Results are sorted by Trial Registration date with most recent record appearing first.

Too many results? You may wish to search again and include different criteria such as your State or Age Group.

Search Parameters
Broad Health Condition: Cancer
Specific Condition: Head and neck
Recruitment Status: Recruiting

Refine Results
ACTNSWNTQLDSATASVICWA

Tracheostomy fenestration: Does it increase upper airway flow?

Print record Print record
Trial Information

Trial summary

The purpose of this study is to see if a tracheostomy tube that has a window (called a fenestration) can increase airflow through the upper airway and improve speech when compared to tubes that don't have the window, in patients having surgery.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with a head and neck cancer, and as part of your surgical management have an uncuffed fenestrated tracheostomy in-situ.

Study details
Patients will be first randomised to either the intervention (fenestrated inner tube) or the control (non-fenestrated inner tube), however all participants will experience both the intervention and the control at some point in time.

The interventions will involve changing the inner tubes and seeing an effect on upper airflow. The study will involve several tests, including directly looking at where the fenestration (or, window) sits in the trachea. 

It is hoped this research will demonstrate that fenestrated tubes can improve airflow and therefore make it easier for patients to speak.

Broad Health ConditionTracheostomy
Head and neck cancer

Specific Health ConditionCancer
Head and neck
Respiratory
Other respiratory disorders / diseases

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
SA

Hospital
The Royal Adelaide Hospital - Adelaide

Postcode
5000 - Adelaide

Anticipated date of last participant enrolment22/10/2021

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Any adult patient with Head and Neck cancer who has an uncuffed fenestrated tracheostomy in-situ, and who is able to tolerate corking (that is, prolonged occlusion of the tracheostomy tube via a cork or cap). 

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Patients unable to tolerate corking (prolonged tube occlusion)
Patients unable to participate in spirometry due to inadequate lip seal
Moribund patients, unlikely to survive hospital admission
Patients with cognitive impairment who are unable to consent or follow instructions 
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Royal Adelaide Hospital ENT department
Primary Sponsor Address: Royal Adelaide Hospital ENT department 1 Port Rd, Adelaide South Australia 5000
Primary Sponsor Country: Australia

Trial IDACTRN12621001384842

UTNU1111-1236-0800

Contact person for information and recruitmentDr
Lee Pryor
Speech Pathology Department Royal Adelaide Hospital 1 Port Rd, Adelaide South Australia 5000
+61 415 565 591

Further information iconlee.pryor@sa.gov.au
Australia

Assessing the effectiveness of Hospital-Based Manufactured Medical Device Restorabite for treatment of Trismus in adults after head and neck cancer surgery

Print record Print record
Trial Information

Trial summary

This study aims to assess the efficacy of Restorabite, a trismus treatment device, as an early intervention for trismus and its impact on quality of life for patients with head and neck cancer.

Who is it for?
You may be eligible for this study if you are aged 18 or older, you have a diagnosis of head and neck cancer, and you are experiencing trouble opening your jaw wider than 35mm.

Study details
Participants will attend 10 x 1 hour weekly sessions with a speech pathologist, where they will be taken through passive and active jaw range of motion exercises. They will also be instructed to complete 20 minutes of home practice daily over the 10 week study period. Data on changes in jaw opening distance and quality of life will be collected over a 12 month period.

It is hoped that this study will demonstrate that the Restorabite device is effective in treating trismus in patients with head and neck cancer, which could lead to an improvement in quality of life for these patients.

Broad Health ConditionTrismus
Head and Neck Cancer

Specific Health ConditionMusculoskeletal
Other muscular and skeletal disorders
Cancer
Head and neck
Oral and Gastrointestinal
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
The Chris O’Brien Lifehouse - Camperdown

Hospital
Wollongong Hospital - Wollongong

Postcode
2050 - Camperdown

Postcode
2500 - Wollongong

Anticipated date of first participant enrolment1/07/2021

Anticipated date of last participant enrolment1/07/2022

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

•	18 years and older
•	Diagnosis of head and neck cancer (HNC)
•	Undergone surgery for their HNC
•	Patients with an interincisal distance (IID) of 35mm or less 
•	Willingness to give informed consent

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Patients where trismus therapy is contraindicated due to medical/surgical parameters, guided by their managing physician. 
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Chris O'Brien Lifehouse
Primary Sponsor Address: 119-143 Missenden Road Camperdown NSW 2050
Primary Sponsor Country: Australia

Trial IDACTRN12621000585820

Contact person for information and recruitmentDr
Masako Dunn
Chris O'Brien Lifehouse 119-143 Missenden Road Camperdown NSW 2050
+61 2 8514 0411

Further information iconMasako.Dunn@lh.org.au
Australia

Investigating taste changes in patients with head and neck cancer and their association with genes and dietary behaviour

Print record Print record
Trial Information

Trial summary

Project Aims - This project aims to assess the feasibility of conducting a study to determine a patient’s individual taste status prior to receiving cancer treatment, and how these radiotherapy and chemotherapy treatments impact on their taste and dietary behaviour after treatment completion.

Who is it for? - You may be eligible for this study if you are aged 18 years or older and you are undergoing radiotherapy or chemoradiotherapy treatment for head and neck squamous cell cancer.

Study Details - Participants who enrol in this study will be asked to complete a series of questionnaires about their diet and taste perceptions prior to starting treatment, and again at 1 month, 3 months and 6 months after treatment completion. It is anticipated that participants will be able to complete these questionnaires & assessments via a telehealth appointment of approximately 45 minutes, and an additional 30 minutes completing an online survey, at each of the timepoints described.

Study Outcomes - It is hoped this research will provide valuable data on the effect cancer treatments may have on the taste and smell perceptions of patients with head and neck cancer and how this impacts on their ability to eat. This data will also be used to inform a larger study to identify possible genetic markers for these individual variations.

Broad Health ConditionHead and neck cancer
Taste perception
Dietary Intake
Nutritional Status

Specific Health ConditionCancer
Head and neck
Diet and Nutrition
Other diet and nutrition disorders

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Royal Brisbane & Womens Hospital - Herston

Postcode
4029 - Herston

Anticipated date of last participant enrolment10/09/2021

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

All patients aged > 18 years undergoing curative intent definitive radiotherapy or chemoradiotherapy (unilateral or bilateral) for oral cavity, oropharyngeal or hypopharyngeal HNSCC at RBWH who can provide written informed consent. Participants will also need to have appropriate technology (e.g. computer/tablet/smart phone with internet connection) to support telehealth sessions and completion of the online dietary assessments.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Age <18, unable to communicate in English, inability to provide written informed consent, sensory (taste) dysfunction of other medical causes (including history of traumatic brain injury, history of neurological disorders, history of middle ear surgery/infection) and current smoker. 
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Teresa Brown
Primary Sponsor Address: Nutrition & Dietetics Royal Brisbane Women's Hospital Butterfield Street Herston QLD 4029
Primary Sponsor Country: Australia

Trial IDACTRN12621000391875

UTNU1111-1263-5345

Contact person for information and recruitmentDr
Teresa Brown
Department of Nutrition & Dietetics Level 2 James Mayne Building Royal Brisbane & Women's Hospital Butterfield Street Herston QLD 4029
+61 7 3646 6043

Further information iconteresa.brown@health.qld.gov.au
Australia

Pharmacogenomics guided dosing of anticancer therapies for patients with cancer

Print record Print record
Trial Information

Trial summary

A multi-site prospective study to implement and evaluate the feasibility of a Pharmacogenetics Screening Program for 5-fluorouracil [5-FU], capecitabine and irinotecan chemotherapies for patients with cancer

Who is it for?
You may be eligible to join this study if you are aged 18 and above, have been diagnosed with cancer and will receive fluorouracil [5-FU], capecitabine and/or irinotecan chemotherapy for the first time.

Study details
All participants in this study will receive a genetic screening for DPYD gene test if commencing on 5-FU or capecitabine and/or screening for UGT1A1 gene if commencing on irinotecan anticancer treatment, 7 to 10 days before starting chemotherapy. It is the responsibility and choice of the treating clinician to implement/not implement dosing recommendations based on genetic tests and to manage all aspects of cancer treatment. 

The feasibility of operating a Pharmacogenetics Screening Program will be assessed using recruitment data from study databases and patient and clinician surveys. Participants will also be followed for up to 12 months to assess toxicities and 24 months to assess treatment response and status. 

This research will contribute to improve health outcomes for patients with cancer in terms of safety and survival in particular patients who carry altered/deficient genes; dose individualisation prior to administration to 5-FU or capecitabine and/or irinotecan will assist with better tolerance to treatment and hospitalisations (given better toxicity management).

Broad Health ConditionGastrointestinal cancers
Breast cancer
Head and neck cancer
Gynaecological cancers
Urogenital cancers

Specific Health ConditionCancer
Oesophageal (gullet)
Cancer
Breast
Cancer
Biliary tree (gall bladder and bile duct)
Cancer
Bladder
Cancer
Bowel - Anal
Cancer
Cervical (cervix)
Cancer
Head and neck
Cancer
Pancreatic
Cancer
Stomach

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,VIC

Hospital
Peter MacCallum Cancer Centre - Melbourne

Hospital
Bendigo Health Care Group - Bendigo Hospital - Bendigo

Hospital
Border Medical Oncology - Albury

Hospital
Swan Hill District Health - Swan Hill

Postcode
3000 - Melbourne

Postcode
3550 - Bendigo

Postcode
2640 - Albury

Postcode
3585 - Swan Hill

Anticipated date of first participant enrolment17/03/2021

Anticipated date of last participant enrolment17/03/2022

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.	Aged 18 years or older 
2.	First time exposure to fluoropyrimidine and/or irinotecan chemotherapy for cancer treatment (any line of treatment, any cancer diagnosis, any stage of disease).
3.	Previously enrolled patients in the Peter Mac Pharmacogenetics Screening Program, for purpose of consenting for collection and storage of research samples for future genomic testing. 

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Patients that have had prior exposure to fluoropyrimidine and irinotecan, other than those previously enrolled in the Peter Mac Pharmacogenetics Screening program who are included only for research sample collection. 
2.	Patients with known DPD deficiency or Gilberts’ syndrome 
3.	Patients undergoing cytoreduction surgeries and HIPEC planned to receive HIPEC, single dose 5-fluorouracil
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Peter MacCallum Cancer Centre
Primary Sponsor Address: 305 Grattan St, Melbourne, 3000, VICTORIA
Primary Sponsor Country: Australia

Trial IDACTRN12621000251820

UTNU1111-1262-0278

Contact person for information and recruitmentMrs
Sarah Glewis
Peter MacCalum Cancer Centre, Pharmacy Department, 305 Grattan Street, Melbourne, 3000, VICTORIA
+61 385595628

Further information iconsarah.glewis@petermac.org
Australia

Longitudinal Assessment of Sexual Health in patients with human papillomavirus associated oropharyngeal cancer

Print record Print record
Trial Information

Trial summary

The purpose of this research study is to observe any changes in sexual health that patients may have following the diagnosis and treatment of a head and neck cancer called oropharyngeal cancer (which includes tonsil and base of tongue cancers).

Who is it for?
You may be eligible for this study if you are aged 18 years or older, and you have started chemoradiotherapy or radiotherapy for human papillomavirus (HPV)-associated oropharyngeal cancer in the last week, or are about to start chemoradiotherapy or radiotherapy for HPV-associated oropharyngeal cancer soon.

Participants enrolled in this study will be asked to attend up to five study visits at the Peter MacCallum Cancer Centre, starting from enrolment and continuing each year up until 2 years after they have completed chemoradiotherapy or radiotherapy treatments. Each study visit will take approximately 40 minutes and participants will be asked to complete a series of questionnaires about their sexual health, quality of life, head and neck symptom burden, emotional distress, body image, resilience and levels of optimism. Participants will also be asked to list in order how important sexual function is compared to other functions such as swallowing and eating.  These questionnaires will be administered in either a paper or electronic format and patients will be able to answer the majority of the questionnaires at home, except for the exercise where patients will be asked to order their priorities (sexual function, swallowing, eating) which will be done in the hospital face to face with a member of the study team.  

It is hoped this research may be used to improve health outcomes for future patients with human papillomavirus-associated oropharyngeal cancer by determining how chemoradiotherapy and radiotherapy treatments impacts sexual health and function

Broad Health Conditionoropharyngeal cancer
sexual health
human papillomavirus

Specific Health ConditionCancer
Head and neck

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
Peter MacCallum Cancer Centre - Melbourne

Hospital
Peter Maccallum Cancer Centre - Moorabbin Campus - Bentleigh East

Postcode
3000 - Melbourne

Postcode
3165 - Bentleigh East

Anticipated date of first participant enrolment12/10/2020

Anticipated date of last participant enrolment31/12/2021

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.	Male or female aged 18 years and over at screening. 
2.	Received curative-intent CRT/RT for human papillomavirus associated oropharyngeal cancer  (based on p16 status).
3.	Will be available for routine post treatment follow up 
4.	Sufficient English literacy to complete study measures 

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Evidence of metastatic oropharyngeal cancer 
2.	Carcinoma of unknown primary 
3.	Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.
4.	Medical comorbidities which impact the validity of the study result (sexual health outcomes) e.g. Parkinson’s Disease, recent MI
5.	Other active or treated malignancy which may interfere with the validity of results e.g. breast or prostate cancer
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Peter MacCallum Cancer Centre
Primary Sponsor Address: 305 Grattan Street Melbourne, Victoria, Australia, 3000
Primary Sponsor Country: Australia

Trial websiteN/A

Trial IDACTRN12620001027909

Contact person for information and recruitmentDr
Lachlan McDowell
Department of Radiation Oncology Peter MacCallum Cancer Centre 305 Grattan Street Melbourne, Victoria, Australia, 3000
+61 3 85597789

Further information iconlachlan.mcdowell@petermac.org
Australia

Magnetic Sentinel Lymph Node Mapping in Oral Squamous Cell Carcinoma: A Phase I Feasibility and Validity Clinical Trial

Print record Print record
Trial Information

Trial summary

The objective of this research program is to investigate new magnetic technology to determine the feasibility of detecting microscopic spread of Oral Squamous Cell Carcinoma (OSCC) to the neck.

Who is it for?
This study will enrol adults aged 18 years or over who have a biopsy proven T1-T2 oral SCC (tongue, RMT, buccal mucosa, FOM, hard palate).

Study details
Study participants will be injected with a single dose of MagTrace or FerroTrace magnetic tracer. One of these two tracers will be delivered around the tumour in 5 injections. The tracer will be used to identify sentinel lymph nodes (nodes that are likely to contain cancer) which will then be surgically removed.

It is hoped this research will provide a new method able to detect cancer metastasis (spread to other body parts), and will also reduce complications associated with oral cancer surgery.  

Broad Health ConditionOral Cancer

Specific Health ConditionCancer
Head and neck

Trial FocusDiagnosis

Recruitment statusRecruiting

Recruitment Details
Recruitment State
SA

Hospital
The Royal Adelaide Hospital - Adelaide

Postcode
5000 - Adelaide

Anticipated date of last participant enrolment31/12/2021

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

- Age 18 or older
- Willing to provide informed consent 
- ECOG status 0-2 
- Biopsy proven T1-T2 oral SCC (tongue, RMT, buccal mucosa, FOM, hard palate)
- Clinically and radiologically N0 neck on contrast enhanced CT or gadolinium enhanced MRI +/- (USS or FDG PET) 
- No distant metastases
- Primary tumours amenable to surgical resection 


Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

- Serious medical comorbidities or other contraindications to surgery +/- adjuvant therapy 
- Advanced T-stage primary tumour (>T2) 
- Primary tumours not amenable to surgical resection 
- Previous HNSCC
- Previous head and neck radiotherapy at any time
- Lip involvement 
- Allergy or Intolerance to iron oxide or dextran compounds
- Metal implant close to site of sentinel lymph node
- Iron overload disorder 
- Standard contraindications to MRI scanning 
- Pregnant or lactating women  
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Central Adelaide Local Health Network trading as Royal Adelaide Hospital
Primary Sponsor Address: CALHN Research Office RAH Clinical Trial Centre Wayfinder 3D460.02 Level 3, Royal Adelaide Hospital Port Road, Adelaide SA 5000
Primary Sponsor Country: Australia

Trial IDACTRN12620000831987

Contact person for information and recruitmentDr
Giri Krishnen
Royal Adelaide Hospital Port Road, Adelaide SA 5000
+61 8 8222 7158

Further information icongiri.krishnan@adelaide.edu.au
Australia

A Phase 1b, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ST-617 for the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for Head and Neck Cancer

Print record Print record
Trial Information

Trial summary

Introduction
As you are going to be treated with chemoradiation therapy for your head and neck cancer, you will most likely develop oral mucositis. As such this study is testing an experimental treatment for oral mucositis. This experimental treatment is called ST-617. 
Oral mucositis involves painful ulcers or lesions developing in the lining of your mouth.  There are currently no approved medicines to successfully prevent and/or treat oral mucositis for head and neck cancer patients. Most patients are treated with best supportive care (BSC) which includes such things as making sure you are taking care of your mouth properly, providing ice chips or lozenges to suck on, or swishing with a mouthwash.
This study aims to test the safety and tolerability of ST-617 on patients and their oral cavities while they are being treated with chemoradiation for head and neck cancer. There are two arms to this study, Phase 1b and Phase 2. It is hoped that the Phase 1 arm will help determine the recommended dose of ST-617 that will be used in head and neck cancer patients in the Phase 2 study.
ST-617 is a medication that has been widely studied in multiple human clinical trials and belongs to a group of medications that have been shown to help protect cells from damage.
Who is it for?
You may be eligible for this study if you are an adult who has been diagnosed with head and neck cancer who is planning to undergo chemoradiation.
Study details
In the Phase 1b part of the study participants will receive either Best Supportive Care (BSC) alone, or BSC plus an oral suspension of ST-617 administered daily for 3 days prior to the start of radiation, and then daily during radiation treatment.
Participants will attend hospital visits for approximately 4 months. After the last visit, their study doctor will check on the status of their cancer every 3 months for up to 1 year after they started radiation.
Most of the exams, tests, and procedures that will be done during this study are part of regular medical care, but will be done multiple times so more information can be gathered. 
Participation in this study will be divided into different visits: Screening Period, Treatment Period, End of Treatment, 30-Day Safety Follow-Up and Response Follow-Up Visits.
Blood will be taken from a vein in the participants’ arm for testing of their general health and to check their medical condition.

Broad Health ConditionOral Mucositis
Head and Neck Cancer

Specific Health ConditionCancer
Head and neck
Oral and Gastrointestinal
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,SA,VIC

Hospital
The Chris O’Brien Lifehouse - Camperdown

Hospital
Liverpool Hospital - Liverpool

Hospital
Flinders Medical Centre - Bedford Park

Hospital
Barwon Health - McKellar Centre campus - North Geelong

Hospital
The Royal Adelaide Hospital - Adelaide

Postcode
2050 - Camperdown

Postcode
2170 - Liverpool

Postcode
5042 - Bedford Park

Postcode
3215 - North Geelong

Postcode
5000 - Adelaide

Trial location outside Australia

Country
South Africa

Phase of TrialPhase 1

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Patient Inclusion Criteria
Each patient must meet all the following criteria to participate in the study:

1. Histopathologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or nasopharynx.

2. Unknown Human Papillomavirus (HPV) positive primaries thought to be of oropharyngeal origin may be included if other inclusion criteria are met.

3. Documentation of HPV status for tumors of the oropharynx, tonsils or base of tongue. HPV status is determined by testing of the tumor (not an oral swab).

4. Planned therapy to include a continuous course of external beam radiation to include intensity-modulated radiotherapy (IMRT) with concurrent cisplatin monotherapy administered every week (30-40 mg/m2 for 6-7 doses) or every 3-weeks (60-100 mg/m2 for 3 doses).

5. Planned total radiation dose of between 60-72 Gy administered in single daily fractions of 2.0-2.2 Gy.

6. Radiation field must include at least 2 mucosal sites within the oral cavity (buccal mucosa, floor of mouth, lateral or ventral tongue, anterior tonsillar pillars, or soft palate) in which both sites receive a minimum cumulative radiation dose of 55 Gy.

7. Patient able to voluntarily provide written informed consent to participate in the study.

8. Capable of understanding and complying with the protocol requirements.

9. Adult patients aged between 18 to 75 years old.

10. Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 2.

11. Adequate organ and bone marrow function as defined by:
a. Absolute neutrophil count (ANC) greater than or equal to 1.0 × 10^9/L (1,000/mm^3).
b. Haemoglobin (Hgb) greater than or equal to 9.0 g/dL.
c. Platelets greater than or equal to 75 × 10^9/L (75,000/mm^3).
d. Bilirubin less than or equal to 1.5 x the upper limit of normal (ULN).
e. Serum creatinine less than or equal to 1.5 x ULN or calculated creatinine clearance greater than or equal to 60 mL/min.
f. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 x ULN if no liver involvement, or less than or equal to 5 x ULN with liver involvement.
g. Albumin less than or equal to 3.5 g/dL or within normal range.

12. No evidence of any active oral mucositis (must be Grade 0 on WHO scale).

13. Ability to swish and swallow fluids in mouth without difficulty.

14. Able to minimise time in direct sunlight while on protocol.

15. Sexually active patients must agree to use medically-accepted barrier methods of contraception (e.g., male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 3 months after the last dose of study drug.

16. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test at screening. WCBP includes any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal.

17. Patient’s written informed consent to test for the human immunodeficiency virus (HIV).

Minimum age18 Years

Maximum age75 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Patient Exclusion Criteria
Patients who meet any of the following criteria will be excluded from the study:

1. Planned continuation of cisplatin or other chemotherapy following radiotherapy.

2. Patients with known infection of Human Immunodeficiency Virus (HIV) or have clinical signs and symptoms consistent with current HIV infection.

3. Known presence in serum of Hepatitis B surface antigen.

4. Evidence of any current active oral mucositis (must be Grade 0 on WHO scale).

5. Prior treatment including:
a. Radiotherapy or brachytherapy to the head and neck;
b. Cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) within 3 weeks, or nitrosoureas / mitomycin C within 6 weeks before the first dose of study treatment;
c. Treatment with therapeutic antibody less than 4 weeks before the first dose of study treatment;
d. Small molecule kinase inhibitor or other small molecule investigational agent within 14 days or 5 half-lives of the compound or active metabolites, whichever is greater, before the first dose of study treatment.

6. The patient has not recovered from toxicity due to all prior therapies (i.e., return to pre-therapy baseline or to Grade 0). Persistent > Grade 0 toxicity from prior therapy will be considered by the Sponsor for inclusion if there is no evidence of an overlapping ST-617 toxicity.

7. Major surgery within 21 days prior to first dose of study drug.

8. Current untreated or unresolved oral candidiasis or oral herpes simplex virus (HSV) infection.

9. History of thromboembolic or peripheral vascular disease (including Raynaud’s and systemic lupus erythematosus (SLE)).

10. Grade 2 or greater baseline neuropathy.

11. History of malabsorption or other gastrointestinal disease that may significantly alter the absorption of ST-617 (e.g., greater than or equal to Grade 2 nausea, vomiting or diarrhea).

12. History of poorly controlled Type 1 or Type 2 diabetes mellitus, with a haemoglobin A1c greater than or equal to 8%.

13. Uncontrolled significant intercurrent illness including, but not limited to, ongoing or active infection, history of congestive heart failure within 6 months, hypertension, unstable angina pectoris within 6 months, stroke within 6 months, myocardial infarction within 6 months, or cardiac arrhythmias. (Controlled chronic atrial fibrillation will not be excluded).

14. QTc interval corrected by Fridericia’s method greater than 450 msec for male patients or greater than 470 msec for female patients or history or risk factors for or use of medications known to prolong QTc interval or that may be associated with Torsades de Pointes (TdP) within 7 days of treatment start. CredibleMeds list of drugs known to cause TdP may be used as a reference for this study to determine which drugs are prohibited using the following link: https://crediblemeds.org/new-drug-list or a crediblemeds mobile application.

15. History of other medical or psychiatric illness or organ dysfunction which, in the opinion of the Investigator, would either compromise the patient’s safety or interfere with the evaluation of the safety of the study agent.

16. Concurrent administration of strong inhibitors of CYP3A4.

17. Concurrent administration of drugs that enhance photosensitivity.

18. The patient has a previously identified allergy or hypersensitivity to components of the study treatment formulation, dithiolethiones or platinum compounds.

19. Pregnant or breast-feeding women.

20. Unable to eat a solid diet due to sequelae of surgery or tumor, or gastrostomy-feeding dependence at baseline.
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: PSI CRO Australia Pty. Ltd.
Primary Sponsor Address: Suite 2.01, 16 Giffnock Avenue, Macquarie Park, NSW 2113
Primary Sponsor Country: Australia

Trial IDACTRN12620000541909

Contact person for information and recruitmentMs
Justine Lee
PSI CRO Australia Pty. Ltd. Suite 2.01, 16 Giffnock Avenue, Macquarie Park, New South Wales, 2113.
+61 2 8582 1672

Further information iconjustine.lee@psi-cro.com
Australia

A Phase I study of increasing doses of T3011 in patients with advanced cancer

Print record Print record
Trial Information

Trial summary

The purpose of this study is to assess the safety of a genetically modified virus, called T3011 in advanced cancer

Who is it for?
You may be eligible for this study if you are aged 18 or over and have advanced cancer presenting with a skin or subcutaneous (under the skin) malignancy.

Study details
All participants in this study will have injections into their tumour(s). These injections will contain the genetically modified virus T3011, which is oncolytic – this means it bursts open cancer cells. The dose administered will increase for each new cohort until the maximum tolerated dose is identified. Participants will have the injection every 2 weeks for up to 2 years, depending on how well the treatment is tolerated. As part of the study, participants will provide saliva, blood and urine samples.

It is hoped this research will provide some safety data for T3011 and identify the appropriate dose of T3011 for bigger clinical trials.

Broad Health ConditionAny malignancy with cutaneous and/or subcutaneous tumours

Specific Health ConditionCancer
Other cancer types
Cancer
Malignant melanoma
Cancer
Non melanoma skin cancer
Cancer
Head and neck
Cancer
Sarcoma (also see 'Bone') - soft tissue

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
SA,VIC

Postcode
3199 - Frankston

Postcode
5042 - Bedford Park

Postcode
3004 - St Kilda Road Melbourne

Trial location outside Australia

Country
United States of America

State
Texas

Country
United States of America

State
Arizona

Anticipated date of first participant enrolment1/06/2020

Phase of TrialPhase 1

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. See Age criteria
2. Histologically confirmed diagnosis of cutaneous OR subcutaneous advanced malignancy.
3. Measurable disease per RECIST version 1.1.
4. Must have at least 1 tumour lesion with a longest dimension of greater than or equal to 10 mm (greater than or equal to 15 mm for the short axis for malignant lymph node lesions) that can be easily palpated or detected by ultrasound to facilitate IT injection of T3011 (ie, tumour in skin, muscle, subcutaneous tissue, or accessible lymph node).
5. Disease progression after standard-of-care (SOC) therapy or in the opinion of the Investigator unlikely to benefit from SOC therapy.
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
7. Life expectancy > 12 weeks.
8. Adequate bone marrow function defined by ANC of greater than or equal to 1.5 × 10^9/L, platelet count of greater than or equal to 100.0 × 10^9/L, and hemoglobin of greater than or equal to 90 g/L (with or without transfusion).
9. Adequate hepatic function defined as serum total bilirubin < 2.5 × ULN, AST/ALT of less than or equal to 2.5 × ULN (or less than or equal to 5 × ULN in participants with liver metastases).
10. Adequate renal function defined as creatinine clearance > 50 mL/min as determined by the Cockcroft-Gault equation.
11. Female participants must be surgically sterile (or have a monogamous partner who is surgically sterile), or be least 2 years postmenopausal, or commit to using 2 acceptable forms of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives, or abstinence) for the duration of the study and for 6 months following the last dose of study treatment. Male participants must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for 6 months following the last dose of study treatment.
12. Women of childbearing potential (WCBP) must have a negative serum pregnancy test at Screening within 7 days of dosing with T3011.
13. Last dose of previous anticancer therapy greater than or equal to 28 days, radiotherapy > 21 days (concurrent targeted palliative radiotherapy is allowed to non-injected lesions during T3011 treatment), or surgical intervention > 21 days prior to the first dose of T3011.
14. Resolution of all prior anticancer therapy toxicities (except for alopecia) to less than or equal to Grade 1.
Note: patients previously treated with immunotherapy who have endocrinopathies may enrol if on adequate replacement therapy.
15. Willingness to provide pre- and post-treatment fresh tumour biopsy specimens.
16. Capable of understanding and complying with protocol requirements.
17. Signed and dated institutional review board/independent ethics committee-approved informed consent form before any protocol-directed screening procedures are performed

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Have only tumours with severe fibrosis and therefore not injectable.
2. Patients with injectable tumours impinging upon major airways or blood vessels.
3. Prior treatment with another oncolytic virus or cellular therapy.
4. Requires continued concurrent therapy with any drug active against HSV (acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir).
5. Systemic therapy with immunosuppressive agents within 28 days before the start of T3011 treatment; topical, intranasal, intraocular, or inhaled corticosteroids and physiologic replacement for patients with adrenal insufficiency are allowed.
6. Live vaccines within 4 weeks of initiation of study treatment.
7. Primary or acquired immunodeficient states (leukaemia, lymphoma, human immunodeficiency virus (HIV)/AIDS).
8. Pregnant or lactating.
9. Prior organ transplantation.
10. Active hepatitis B virus, hepatitis C virus, and HIV infection or a positive serological test at Screening within 14 days of dosing with T3011. Positive for HCV Ab only when HCV RNA positive at Screening. Patients who are HBsAg+ and/or HBcAb+ and have a DNA load <2000 IU/mL (10^4 copies/mL) are considered eligible to participate in the study. 
11. Active autoimmune disease or medical conditions requiring chronic steroid
(ie, > 10 mg/day prednisone or equivalent) or immunosuppressive therapy; patients with a prior history of autoimmune disease may be eligible following discussion with and written approval from the Medical Monitor.
12. History of or current central nervous system metastases (brain imaging [eg, by CT scan, PET scan, MRI scan, etc., per site standards] completed within 3 months of Screening [required for all participants]).
13. History of seizure disorders within 6 months of Screening.
14. Active oral herpes lesion at Screening.
15. Baseline pulse oximetry < 92% on room air.
16. Active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring treatment with systemic steroids.
17. Congestive heart failure (> New York Heart Association Class II), active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest), or clinically significant cardiac arrhythmias.
18. History of allergic reactions attributed to compounds of similar biological composition.
19. Known or activie suspected infections with SARS-CoV-2 virus .
20. Other systemic conditions or organ abnormalities that, in the opinion of the Investigator, may interfere with the conduct and/or interpretation of the current study.
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Theravir Pty Ltd
Primary Sponsor Address: Level 13, Citigroup Tower, 2 Park Street, Sydney NSW 2000
Primary Sponsor Country: Australia

Trial IDACTRN12620000008921

UTNU1111-1244-4129

Contact person for information and recruitmentA/Prof
Andrew Haydon
Medical Oncology Alfred Hospital 55 Commercial Rd Melbourne VIC 3004
+61 3 9076 3129

Further information icona.haydon@alfred.org.au
Australia

Testing whether prochlorperazine can be safely used to move anti-cancer therapy targets temporarily to tumour cell surfaces with combination dose increases of cetuximab anti-EGFR antibody.

Print record Print record
Trial Information

Trial summary

The purpose of this study is to determine if a high dose of an anti-nausea drug (called prochlorperazine) is safe to give to patients during chemotherapy treatment, while also seeing if there is a health outcome benefit to patients.

Who is it for?

You may be eligible for this study if you are an adult who has a confirmed head and neck cancer or triple negative breast cancer or an adenoid cystic cancer of the head and neck region. 

Study details

All patients in this study will receive a high dose of the anti-nausea medication 3 days after the commencement of chemotherapy. After this, all participants will receive the anti-nausea medication weekly, with their chemotherapy. There will be 5 different doses of the chemotherapy given in combination with the anti-nausea medication to participants depending on when the participant joins the study, with the doses increasing over time and only increasing if the doses pass safety reviews. 

It is hoped that this research will help determine if the anti-nausea drug is safe in combination with chemotherapy to treat patients, while also testing whether this has an effect on improving health outcomes.

Broad Health ConditionCancer

Specific Health ConditionCancer
Head and neck
Cancer
Breast

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Princess Alexandra Hospital - Woolloongabba

Postcode
4102 - Woolloongabba

Anticipated date of last participant enrolment1/06/2020

Phase of TrialPhase 1

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.	Radiological and/or histologically confirmed relapsed Head and Neck Squamous Cell Carcinoma/Triple Negative Breast Cancer/Adenoid Cystic Carcinoma of the head and neck region.
	
2.	Predicted life expectancy of greater than three months

3.	Male or female greater than or equal to 18 years of age

4.	ECOG performance status 0-2 

5.	Provide informed consent

6.	Able to commit to 4 hours in the clinic and 24 hours without driving and operating machinery
7.	Female patients of child bearing potential will be required to have a negative pregnancy test prior to entry on the study and be required to practice an effective form of contraception.	
8.	TNBC patients:  histologically confirmed tumour overexpression of EGFR

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Treatment with any investigational agent within the preceding 4 weeks or within 5 half-lives of the investigational agent, whichever is longer.

2.	Known hypersensitivity to EGFR inhibitors.

3.	Clinically significant cardiovascular disease (including myocardial infarction,
unstable angina, symptomatic congestive heart failure, serious uncontrolled
cardiac arrhythmia) less than or equal to 1 year before enrolment/randomization.

4.	History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or
evidence of interstitial lung disease previous imaging.

5.	Eastern Cooperative Oncology Group (ECOG) performance status greater than 2

6.	On drugs that cause long QTc  


7.	History of prolonged QT interval or prolonged QT interval on baseline ECG

8.	Systolic blood pressure less than 90mmHg and/or diastolic blood pressure less than 50 mmHg in two consecutive blood pressure readings within the 1 hour prior to study drug administration.

9.	Previous reaction to antipsychotic medications

10.	Parkinsons disease or other chronic extrapyramidal conditions.

11.	Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.

12.	Subject (male or female) is not willing to use highly effective methods of
contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.

13.	High risk for poor compliance.

14.	Any uncontrolled concurrent medical condition that may interfere with the
interpretation of study results.

Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: The University of Queensland
Primary Sponsor Address: Level 7, General Purpose South Building (Building 78) Staff House Road The University of Queensland Brisbane, Queensland 4072
Primary Sponsor Country: Australia

Trial websiteNone

Trial IDACTRN12619001527156

Contact person for information and recruitmentA/Prof
Euan Walpole
Medical Director – Cancer Services Princess Alexandra Hospital and Metro South Health and Hospital Service, Division of Cancer Services, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, Qld, 4102. Australia
+61731765564

Further information iconEuan.Walpole@health.qld.gov.au
Australia

Exploratory Phase Ib/IIa Study of Intratumourally Administered Tigilanol Tiglate to Assess Safety, Tolerability and Tumour Response in Patients with Head and Neck Squamous Cell Carcinoma

Print record Print record
Trial Information

Trial summary

This study aims to evaluate the safety, tolerability and signs of efficacy of a new investigational drug called tigilanol tiglate in participants with head and neck cancer. Who is it for?
Patients may be eligible to join this study if aged 18 years or more and have been diagnosed with head and neck squamous cell carcinoma.
Study details:
All participants in this study will receive between one and three tigilanol tiglate injections directly into 1-4 tumours. Tigilanol tiglate may lead to breakdown of tumour blood vessels and recruitment and activation of white blood cells. This leads to rapid tumour cell death. This drug has previously been tested in humans (see QB46C-H01 - ACTRN12614000685617 and QB46C-H02 - ACTRN12614001207606). Participants will be monitored for at least 3 weeks following tigilanol tiglate injection in order to evaluate safety, tolerability, tumour response and pharmacokinetics (the action of the body on the drug).
The results from this study will be analysed to see if it is worthwhile for this new drug to be tested in future studies involving larger numbers of cancer participants.

Broad Health ConditionHead and neck squamous cell carcinoma.

Specific Health ConditionCancer
Head and neck

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Postcode
4102 - Woolloongabba

Postcode
2010 - Darlinghurst

Trial location outside Australia

Country
India

State
Mumbai, Maharashtra, 400012

Country
India

State
Kolkata, West Bengal, 700160

Anticipated date of first participant enrolment31/10/2019

Anticipated date of last participant enrolment31/12/2021

Phase of TrialPhase 1 / Phase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

A patient will be eligible for study participation (Stage 1 and Stage 2, if applicable) if they meet all of
the following criteria:
1. An adult (>= 18 years old);
2. Willing and able to provide written informed consent prior to any protocol-required procedures and comply with all local and study requirements;
3. Resectable or unresectable, histologically or cytologically confirmed HNSCC, accessible and amenable for IT injection, that meets at least one of the following:
• refractory to at least one round of conventional therapy; or
• no available standard therapy; or
• patient declined standard therapy after appropriate counselling (with the decision documented); or
• patient awaiting surgery or therapy or is explicitly being monitored with the aim of delaying therapy.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
5. Life expectancy more than 12 weeks;
6. Disease that is measurable (i.e., each target tumour >= 2 mm in diameter that can be accurately measured in at least two dimensions) by calliper. Up to 4 measurable target tumours with a maximum combined volume of 150 cm3 and up to 5 non-target tumours to be selected at the discretion of the PI;
7. Selected target tumours that are suitable for biopsy (multiple 2 mm punch sampling) and patient willingness to provide tumour biopsies;
8. Haemoglobin >= 9.0 g/dL, neutrophils >= 1.5 x 10^9/L, and platelets >= 100 x 10^9/L;
9. Total bilirubin =< 1.5 x upper limit of normal (ULN);
10. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN;
11. Plasma creatinine =< 2.0 x ULN;
12. International Normalised Ratio (INR) and APTT =< 1.5 x ULN;
13. Women of child-bearing potential (i.e., not pre-menarchal, surgically permanently sterile [hysterectomy, bilateral salpingectomy and bilateral oophorectomy], or >= 12 months postmenopausal without an alternative medical cause) must not be pregnant (as demonstrated by negative serum beta-human chorionic gonadotropin [hCG] pregnancy test) and all men must agree to use adequate contraception (i.e., sexual abstinence [only if preferred method of birth control]; oral, intravaginal, or transdermal combined estrogen and progesterone hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable progesterone-only hormonal contraception associated with inhibition of ovulation; intrauterine device [IUD]; intrauterine hormone-releasing system [IUS]; bilateral tubal occlusion; or only vasectomized sexual partner[s]) prior to study entry, for the duration of study participation, and for 90 days following the last treatment day. Additionally, men must agree to not donate sperm for the duration of study participation or for 90 days following the last treatment day.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

A patient will be excluded from the study if they meet any of the following criteria:
1. Target tumours intended for treatment immediately adjacent to, or with infiltration into, major arteries or veins;
2. Target tumours intended for treatment located in an area where post-injection swelling could compromise the airway;
3. Target tumours intended for treatment requiring urgent resection;
4. Participated in any investigational intervention study within 30 days prior to study treatment;
5. Treatment with any anti-cancer treatment (e.g., immunotherapy [e.g., anti-PD-1/L1 inhibitor], biological therapy, chemotherapy, anti-cancer vaccine therapy, oncolytic viral or microbial therapy [e.g., T-VEC/Imlygic(TM), toll-like receptor [TLR] agonists, STING or RIG-1], etc.) other than prior tigilanol tiglate injection as part of this study, within 4 weeks prior to study treatment;
6. Oncology related surgery within 4 weeks prior to study treatment;
7. Any previous surgery in the area of the intended target tumour in proximity of the airway (such that tracking of the injected fluid may be unpredictable and could lead to airway swelling);
8. Any radiation therapy to a visceral organ or tumours within 3 weeks prior to study treatment;
9. Any previous radiation of the intended target tumour in proximity of the airway (such that tracking of the injected fluid may be unpredictable and could lead to airway swelling);
10. Unrecovered to CTCAE version 5 Grade 1 or better from the toxic effects of any previous therapy prior to study enrolment, except for fatigue (Grade =< 2) due to radiation treatment and alopecia (Grade =< 2). Other Grade 2 AEs that are deemed as Grade 2 due to replacement hormonal or steroid therapies may qualify for exception to this criterion with approval of the Medical Monitor;
11. Known, uncontrolled CNS metastasis;
12. History of significant tumour bleeding in the target tumour intended for treatment;
13. Therapeutic anticoagulation or antiplatelet agents (e.g., clopidogrel) (Prophylactic doses of low molecular weight heparins or low dose aspirin [=< 150 mg daily] are allowed) (low molecular weight heparin must be stopped at least 24 hours prior to study treatment);
14. A bleeding diathesis or coagulopathy that would make IT injection or biopsy unsafe;
15. Myocardial infarction, unstable angina pectoris, cerebrovascular accident, pulmonary embolism, uncontrolled congestive heart failure, cardiac arrhythmia (except for controlled atrial fibrillation), arterial thrombosis, or transient ischaemic attack within 6 months prior to study treatment;
16. Significant cardiac comorbidity or uncontrolled hypertension (> 150/100 mmHg), despite optimal medical therapy, that may confound the assessment of safety and tolerability;
17. History of allergic reactions attributed to compounds of similar chemical or biologic composition to tigilanol tiglate or other agents used in this study;
18. Uncontrolled bacterial, viral, or fungal infections requiring systemic therapy, known infection with human immunodeficiency virus (HIV), or active infection with Hepatitis B or Hepatitis C;
19. Pregnant or nursing (the effects of tigilanol tiglate on congenital development and nursing infants are unknown);
20. In the opinion of the PI, the patient is an inappropriate candidate for the study;
21. For consideration when entering Stage 2 - Repeat-Dosing only: Any anti-cancer treatment (e.g., immunotherapy, biological therapy, chemotherapy, anti-cancer vaccine therapy, surgery, etc.) to the target tumour since the previous treatment with tigilanol tiglate;
22. For consideration when entering Stage 2 - Repeat-Dosing only: No unacceptable toxicity to a previous tigilanol tiglate injection.
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: QBiotics Group Limited
Primary Sponsor Address: 3A/165 Moggill Road, Taringa, QLD, 4068
Primary Sponsor Country: Australia

Trial IDACTRN12619001407189

UTNU1111-1232-3725

Contact person for information and recruitmentMr
Daniel Swart
QBiotics Group Limited, Suite 3A/165 Moggill Road, Taringa, QLD, 4068
+61 738708933

Further information iconenquiries@qbiotics.com
Australia

Intervention study assessing the novel use of seviteronel in androgen receptor positive cancers

Print record Print record
Trial Information

Trial summary

This study's purpose is to facilitate and expedite the clinical testing of SEVI-D in a population with advanced cancer that are androgen receptor (AR)  positive.  

Who is it for?
You may be eligible for this study if you have a solid tumour with clinical/radiological progression on or following last anticancer therapy.  There study has a focus on, but not exclusive to, rare or neglected cancers. 

Study details
All participants will be screened to confirm if their solid tumour is AR positive by the study team.  If eligible, participants will receive the medications of Serivteronel and Dexamethasone (also known as SEVI-D) by oral tablets continuously per cycle (4 weeks). Participants will be asked to have blood tests, scans, complete questionnaire and regularly meet with the study doctor and team.

It is hoped this research will demonstrate this treatment could be beneficial for the treatment of cancers that are known to be human androgen receptor positive.

Broad Health ConditionSolid cancers

Specific Health ConditionCancer
Bladder
Cancer
Bowel - Anal
Cancer
Cervical (cervix)
Cancer
Head and neck
Cancer
Kidney
Cancer
Liver
Cancer
Lung - Non small cell
Cancer
Other cancer types
Cancer
Sarcoma (also see 'Bone') - soft tissue
Cancer
Malignant melanoma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Postcode
2010 - Darlinghurst

Anticipated date of first participant enrolment1/08/2018

Anticipated date of last participant enrolment31/07/2020

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Received and failed all standard anticancer therapy or have documented unsuitability for any further standard therapy (if standard therapy exists)
2. Clinical or radiological progression on or following last anticancer therapy
3. Patients with AR-positive solid tumours as confirmed by immunohistochemistry
4. Adequate organ system function
5, Ability to comply with study requirements

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Contraindications to investigational product, as listed in the study addendum and outlined in the Investigator Brochure appended to each study module
2. Known history of hypersensitivity to active or inactive components of investigational product
3. Previous treatment with the same agent or same class of agent
4. Treatment with any of the following anticancer therapies prior to the first dose of study treatment:
o Radiation therapy, surgery or tumour embolization within 14 days prior to the first dose of study treatment. Palliative radiotherapy (for analgesia) is acceptable only if the irradiated field does not include target lesions;
o Immunotherapy within 28 days prior to the first dose of study treatment;
o Chemotherapy, biologic therapy, or hormonal therapy within 14 days or 5 half lives of a drug prior to the first dose of study treatment or until recovery from previous therapy (whichever is longer)
5. Administration of any investigational treatment within 30 days or 5 half lives
(whichever is longer) prior to receiving the first dose of study treatment;
6. Any additional exclusion criteria specified in the relevant study addendum.
7. Active prostate cancer requiring treatment.
8. Active breast cancer requiring treatment.
9. Symptomatic central nervous system cancer. Subjects with stable neurological function, on stable doses of steroids/antiepileptics over 4 weeks prior to screening are eligible.
10. Corrected QT interval by the Fridericia correction formula (QTcF) on the screening electrocardiogram (ECG) >470 msec. If the screening ECG QTcF interval is >470 msec, it may be repeated once, and if the repeat ECG is <470 msec, the patient may be enrolled.
11. Clinically significant cardiac arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, torsades de pointes, second degree or third degree atrioventricular heart block without a permanent pacemaker in place).
12. Any medical condition that could preclude patient participation in the study, pose an undue medical hazard, or which could interfere with study results.
13. Class III or IV Congestive Heart Failure as defined by the New York Heart Association functional classification system within the previous 6 months.
14. Known active Human Immunodeficiency Virus, Hepatitis B, or Hepatitis C infections.
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: St Vincent's Hospital
Primary Sponsor Address: 370 Victoria Street Darlinghurst NSW 2010
Primary Sponsor Country: Australia

Trial IDACTRN12618001074280

Contact person for information and recruitmentMr
Robert Kent
The Kinghorn Cancer Centre 370 Victoria St Darlinghurst NSW 2010
+61 2 9355 5711
+61 2 9355 5735
Further information iconSVHS.CancerResearch@svha.org.au
Australia

Smoking cessation and effects of cigarette smoking on cure and side effects of treatment in patients with cancer in the head and neck region.

Print record Print record
Trial Information

Trial summary

This observational study will evaluate smoking cessation and its impact on treatment outcome and survival in patients with head and neck cancer. 

Who is it for?
You may be eligible to join this study if you are aged 18 years or older and have a confirmed diagnosis of Stage I-IV squamous cell carcinoma of the oral cavity, pharynx, larynx, nasal cavity or paranasal sinuses, for which you are deemed suitable for curative treatment at Townsville Cancer Centre. 

Study details
Participants will undergo cancer treatment and may participate in the existing smoking cessation program as per standard of care at Townsville Cancer Centre. They will then be followed up at 3 months, 6 months, 9 months, 1 year, 2 years, 3 years and 5 years post treatment to evaluate a number of outcomes, including smoking cessation rate among smokers, treatment toxicities, and clinical response to treatment. 

It is hoped that the results of this study will help inform patients and health care providers and facilitate improvement in quality of care and patient compliance leading to improved disease control, survival and quality of life. 

Broad Health ConditionHead and Neck Squamous Cell Cancer
Cigarette smoking

Specific Health ConditionCancer
Head and neck
Mental Health
Addiction

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
The Townsville Hospital - Douglas

Postcode
4814 - Douglas

Anticipated date of first participant enrolment12/02/2018

Anticipated date of last participant enrolment1/10/2021

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

	Age 18 years or older
	Histologically confirmed squamous cell carcinoma of the oral cavity, pharynx, larynx, nasal cavity or paranasal sinuses.
	Stage I – IV disease (Any T, Any N M0). 
Any smoking status 
	No distant metastases.
	Deemed suitable for curative treatment by the head and neck multi-disciplinary team.
	ECOG Performance Status 0-1.
	Patients with prior invasive malignancy and disease free for > 3 years.
	Synchronous malignancies are eligible if deemed suitable for curative treatment.
	No pregnant women.
	Provided written Informed Consent for treatment. (only patients who have consented to curative treatment as part of their standard care are eligible for the study)
	Provided written Informed Consent for participation in the study.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

	Histology other than squamous cell carcinoma.
	Recurrent disease
	Pregnancy.
	Prior (megavoltage) radiation therapy to the head and neck region 
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: MADHAVI CHILKURI
Primary Sponsor Address: Townsville Hospital and Health Service P O BOX 670 TOWNSVILLE QLD 4810
Primary Sponsor Country: Australia

Trial IDACTRN12618000165280

Contact person for information and recruitmentDr
MADHAVI CHILKURI
Townsville Hospital and Health Service P O BOX 670 Townsville QLD 4814
+61744331801

Further information iconMadhavi.Chilkuri@health.qld.gov.au
Australia

Phase I non-randomised safety study of prophylactic topical dexamethasone/hyaluronic acid formulation on facial nerves during parotidectomy and neck dissection surgery

Print record Print record
Trial Information

Trial summary

 

This study seeks to determine the safety of applying the potent corticosteroid dexamethasone in a slow release hyaluronic acid gel formulation directly to exposed nerve branches of the facial nerve during standard parotidectomy and neck dissection surgery.

Who is it for?
You may be eligible to join this study if you are aged 18 years or over and are undergoing parotidectomy (malignant or benign) or neck dissection surgery.

Study details
Consenting patients will receive the dexamethasone in a slow release gel formulation directly to the exposed nerve during surgery, in which the surgeon will coat exposed branches of the facial nerve with the formulation once. Consenting participants will undergo their standard clinical treatment involving parotidectomy or neck dissection surgery which includes an initial consult involving facial nerve function assessments, parotidectomy or neck dissection surgery and follow-up visits assessing wound healing/infection and facial nerve function over 2 months.

Broad Health ConditionParotid cancer
Neck cancer
Parotidectomy
Neck dissection surgery

Specific Health ConditionCancer
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer
Head and neck

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
The Chris O’Brien Lifehouse - Camperdown

Postcode
2050 - Camperdown

Anticipated date of first participant enrolment31/01/2018

Anticipated date of last participant enrolment31/07/2018

Phase of TrialPhase 1 / Phase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

•	Undergoing parotidectomy (malignant or benign) or neck dissection surgery
•	Greater than or equal to 18 years of age.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

•	Preoperative assessment that the nerve at risk will need to be intentionally sacrificed
•	Functional assessment by the surgeon indicating that the nerve is not functioning prior to surgery e.g. complete facial palsy
•	Administration of another investigational drug within 30 days prior 
•	Significant neurological or psychiatric disorder
•	Pregnancy  
•	Patients who lack capacity or whom are unable to express informed consent
•	Patients with a mental illness such as to interfere with their ability to understand the requirements of the study or express informed consent
•	Current infective illness 

Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: IntraVital Pty Ltd
Primary Sponsor Address: 1/54 Coogee Bay Rd Randwick NSW 2031
Primary Sponsor Country: Australia

Trial IDACTRN12618000077268

Contact person for information and recruitmentDr
Aparna Krishnan
Chris O'Brien Lifehouse 119-143 Missenden Road CAMPERDOWN NSW 2050
+61 02 8514 0131

Further information iconaparna.krishnan@lh.org.au
Australia

Prospective randomised controlled study of pharyngo-oesophageal dilatation in Head and Neck cancer therapy-induced dysphagia: Evaluation of efficacy and safety

Print record Print record
Trial Information

Trial summary

The primary purpose of this trial is to evaluate the efficacy of pharyngo-oesophageal dilatation for improving ease and comfort of swallowing in patients with head and neck cancer therapy-induced swallowing difficulty.

Who is it for?
You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with head and neck cancer for which surgery and chemoradiation therapy finished at least 12 months previously, which has caused ongoing difficulty swallowing.

Study details
All participants enrolled in this trial will be randomly allocated (by chance) to receive either the dilatation procedures, or to receive a single oeosophageal endoscopy during which no dilatation is provided. Participants in the dilatation group will receive a series of dilatation procedures. These involve passage of dilators to expand the calibre of the oesophagus under sedation and will occur at 2-3 weekly intervals. All participants will be followed up for 2 years following the final procedure to evaluate swallowing symptoms and satisfaction with the treatment.

It is hoped that this trial will provide information on whether pharyngo-oesophageal dilatation may be an effective method for reducing symptoms of difficulties swallowing which have been caused by cancer therapies for head and neck cancer patients.

Broad Health Conditiondysphagia
head and neck cancer

Specific Health ConditionOral and Gastrointestinal
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer
Head and neck

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
St George Hospital - Kogarah

Postcode
2217 - Kogarah

Anticipated date of last participant enrolment29/12/2017

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1) self-reported problematic pharyngeal dysphagia 12 months beyond the surgeries and chemoradiation for head and neck cancer; 2) abnormal Sydney Swallow Questionnaire score (above 234). 

Minimum age50 Years

Maximum age75 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1) local cancer recurrence; 2) any neurological disorders known to cause pharyngeal dysfunction (e.g. Parkinson's disease, cerebral vascular accident, inflammatory myopathy, motor neuron disease). 
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: St George & Sutherland Clinical School, University of New South Wales
Primary Sponsor Address: Clinical Sciences (WRPitney) Building, Short Street, St George Hospital, Kogarah NSW 2217
Primary Sponsor Country: Australia

Trial IDACTRN12617000707369

Contact person for information and recruitmentDr
Peter Wu
Department of Gastroenterology and Hepatology, St George Hospital, Gray St, Kogarah, NSW 2217
+61 2 91132817
+61 2 91133993
Further information iconpeteriungchiang.wu@health.nsw.gov.au
Australia

Phase I Study of Complete Freund’s Adjuvant (CFA) in Patients with Refractory and Relapsed Solid Tumours

Print record Print record
Trial Information

Trial summary

This study will investigate the safety of Complete Freund’s Adjuvant (CFA) in Patients with Refractory and Relapsed Solid Tumours. 

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, have a histologically or cytologically confirmed locally advanced or metastatic solid tumor (melanoma, head & neck, sarcoma, renal and other cancers) for which no curable therapy exists.

Study details
This study involves the use of an investigational drug called CFA. "Investigational" means that the drug has not yet been approved by the Therapeutic Goods Administration (TGA) for treatment of cancer. CFA consists of three ingredients: mineral oil, surfactant, and heat-killed mycobacterium. Injection of CFA into tumour creates a localised depot of killed bacteria, which are slowly released over weeks. This causes an influx of immune cells to the site on injection, and initiates a powerful immune response. The other drug (pembrolizumab) is an approved novel agent for the treatment of metastatic melanoma. Participants in the study will receive CFA in combination with pembrolizumab. 

CFA will be administered in 42 day cycles starting at a dose of 0.5 ml for the first cohort of three patients. These patients will be monitored closely and provided there are no safety concerns additional patients will be enrolled and treated with 1.0 ml of CFA and subsequently a third cohort will be enrolled with a starting dose of 2.0 ml of CFA. Once a participant experiences an adverse event as a result of the CFA dose, this dose level will be expanded with three additional patients enrolled. If two of the six participants experience a reaction the dose will be decreased to the previous level and three additional patients will be added. If one of the six patients experience a reaction that dose will be declared the maximum tolerated dose for CFA. Pembrolizumab will be administered following approved guidelines (2mg/kg) on day 2 of the first cycle and then every three weeks. 

Safety of CFA will be assessed at Day 1 of each 42 day cycle. Participants will be followed for up to 30 days after removal from treatment to determine therapeutic benefit and anti-tumour effect of CFA. Patients removed from treatment for unacceptable adverse events will be followed up until resolution or stabilization of the adverse event.

Broad Health ConditionSolid Tumours

Specific Health ConditionCancer
Head and neck
Cancer
Malignant melanoma
Cancer
Sarcoma (also see 'Bone') - soft tissue

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT

Hospital
The Canberra Hospital - Garran

Postcode
2605 - Garran

Anticipated date of last participant enrolment1/11/2017

Phase of TrialPhase 1

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Histologically/cytologically confirmed locally advanced or metastatic solid tumors (melanoma, head & neck, sarcoma, renal and other cancers) for which no curable therapy exists. Melanoma patients will be allowed to enroll in the dose escalation phase of single agent study following progression or intolerance of ipilimumab/pembrolizumab (or both). Patients who are not suitable or decline treatment with ipilimumab/pembrolizumab (or both) will also be allowed to participate during dose escalation. Previous treatment with a PD1 inhibitor agent is not allowed in dose expansion phase. However, previous treatment with ipilimumab is allowed in dose expansion phase.

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

Adequate marrow function as defined below: 
a-	absolute neutrophil count greater than or equal to 1.0 x 10^9/L
b-	platelets greater than or equal to 100,000 x 10^9/L
c-	INR less than 1.5 x ULN

Evidence of at least one measurable and easily accessible cutaneous or subcutaneous lesion that could be injected with CFA but preferably three lesions (other two for a biopsy and tumour assessment each). In patients who have a single measurable lesion, it can be used for intratumoral injection, biopsy and response measurement.

Adequate liver function as evidenced by bilirubin <1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <3 times the ULN or <5.0 x ULN if liver metastases are present.

Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female of childbearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: has not undergone a hysterectomy or bilateral oophorectomy, or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 

Recovery from all AE of prior cancer therapies including surgery and radiotherapy, to baseline or CTCAE Grade greater than or equal to 1, except for alopecia.

No prior therapy with CFA or similar agents. Melanoma, head & neck cancer, sarcoma and renal cancer patients will be allowed to enrol in the dose escalation phase of the study. However, enrolment into dose expansion phase Ib will be restricted to melanoma patients with no prior exposure to anti-PD1 agent.

Patients with treated brain metastases, provided that they are clinically stable for a period of 30 days prior to study entry.

These criteria will also be in effect for the dose escalation and expansion stages of the study

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Preexisting > grade 2 peripheral neuropathy

Treatment with any of the following anti-cancer therapies prior to the first dose of CFA within the stated timeframes: intravenous chemotherapy within a period of 4 weeks (6 weeks for nitrosourea, mitomycin-C), biological therapy (e.g. antibodies) within a period of time that is ~ 5 t1/2 or less than 4 weeks, whichever is shorter, prior to starting study drug, any other investigational agents within a period of time that is < 5 tl/2 or 4 weeks (whichever is shortest) prior to starting study drug, wide field radiotherapy  <4 weeks or limited field radiation for palliation <2 weeks prior to starting study drug.

History of cardiac disease (Congestive heart failure NYHA grade > 2, LVEF < 40% as determined by MUGA scan or ECHO, history of clinically significant ventricular arrhythmias, uncontrolled hypertension, unstable angina pectoris or acute myocardial infarction <6 months prior to starting study drug, QTcF > 450 msec), or history of Torsades de pointes.

Pregnant or nursing (lactating) women.

These criteria will also be in effect for the dose escalation and expansion stages of the study
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Canberra Hospital Medical Oncology Department
Primary Sponsor Address: Medical Oncology Clinical Trials Building 19, Level 5 Canberra Hospital Yamba Drive Garran, ACT, 2605
Primary Sponsor Country: Australia

Trial IDACTRN12616001637437

Contact person for information and recruitmentMrs
Olive Doig
Building 19, Level 5 Canberra Hospital Yamba Drive Garran, ACT, 2605
+612 6244 3856

Further information iconOlive.Doig@act.gov.au
Australia

The PACT Study: Psychosocial Assessment, Care and Treatment of patients with urological and head and neck cancers.

Print record Print record
Trial Information

Trial summary

This study is developing, and evaluating the feasibility, cost and acceptability of, a patient-centred, integrated model of psychosocial care for people receiving treatment for urological or head and neck cancers. 
Who is it for? 
You will be eligible to join this study if you are aged 18 years or above and have been diagnosed with a urological cancer or a head and neck cancer, for which you are receiving inpatient and/or outpatient care at John Hunter Hospital. 
Trial details 
All participants in this study will receive treatment, as required, under the PACT (Psychosocial Assessment, Care and Treatment) model. As part of this newly developed model of care, all inpatient and outpatient urology and head and neck cancer patients will be screened at their first diagnostic or treatment visit and at each subsequent follow-up visit, using the Distress Thermometer (DT) and accompanying Problem Checklist. This will be used to develop a care plan to address any issues identified through the screening and second-line inquiry. The care plan will facilitate the provision of care which is tailored to the specific needs of patients, and promote continuity of care across care settings and providers; including with health care providers (HCPs) in rural and regional areas. 
Participants will be asked to report experiences of their cancer care at baseline, and at 21 and 30 months after intervention commencement. It is anticipated that implementation of this model will improve continuity of care, increase health care professionals' awareness, confidence, knowledge and skills to discuss and respond to patients' specific concerns, and improve access to specialised psychological care services.

Broad Health ConditionUrological cancers
Head and Neck cancers

Specific Health ConditionCancer
Head and neck
Cancer
Prostate
Cancer
Other cancer types

Trial FocusEducational / counselling / training

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
John Hunter Hospital Royal Newcastle Centre - New Lambton

Postcode
2305 - New Lambton

Anticipated date of first participant enrolment14/03/2013

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Key patient inclusion criteria are: a) aged 18 years or over, b) diagnosed with a urological cancer or a head and neck (H&N) cancer, and c) receiving inpatient and/or outpatient care at John Hunter Hospital. 

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Key patient exclusion criteria are: a) aged below 18 years, b) not diagnosed with a urological or a head and neck (H&N) cancer, and c) not receiving any inpatient or outpatient care at John Hunter Hospital. 
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: The University of New South Wales
Primary Sponsor Address: High St UNSW KENSINGTON NSW 2052
Primary Sponsor Country: Australia

Trial IDACTRN12613000916741

Contact person for information and recruitmentMs
Hayley Candler
c/- CTNMH, University of Newcastle, PO Box 833, NEWCASTLE NSW 2300
+61240335118
+61240335692
Further information iconhayley.candler@unsw.edu.au
Australia

Eating As Treatment (EAT): A stepped wedge, randomised control trial of a health behaviour change intervention provided by dietitians to improve nutrition in head and neck cancer patients undergoing radiotherapy

Print record Print record
Trial Information

Trial summary

This study is evaluating the effectiveness of a dietitian delivered health behaviour intervention to reduce malnutrition in head and neck cancer patients undergoing radiotherapy.

Who is it for? 

This study is taking place within six Australian Hospitals. You may be eligible to join this study if you are aged 18 years or more, and have a confirmed diagnosis of cancer involving the nasopharynx, oropharynx, oral cavity, larynx, or hypopharynx requiring definitive or postoperative radiotherapy with curative intent. 

Trial details 

All sites will begin in the ‘control’ condition – dietitians will provide ‘treatment as usual’. Participants recruited during this phase will receive treatment as usual by trained dietitians according to standard hospital practice. At a randomly determined time point, researchers will attend the hospitals to provide training to the dietitians. Dietitians will then provide ‘EAT’ (Eating as Treatment) as part of standard dietetic consultations (weekly during treatment, fortnightly for six weeks and then ‘as needed’). You will not be aware of whether you are participating in the 'control' or 'intervention' phase.

EAT is a dietitian delivered health behaviour change intervention designed to improve health behaviours of head and neck cancer patients and maintain their nutrition over the course of their radiotherapy. Of particular interest are behaviours related to sufficient daily nutritional intake, either orally or via feeding tube. 

Participants will be regularly assessed for up to 12 weeks post radiotherapy treatment in order to evaluate nutrition status. Information about mood, smoking and alcohol use, therapeutic alliance and radiotherapy side effects will also be collected from participants. Medical records will be reviewed to collect a range of information including total radiotherapy treatment time, unplanned hospital visits, length of stay, dietitian contact and referral to appropriate services for depression. 

Broad Health ConditionHead and Neck Cancer Patients Undergoing Radiotherapy
Depression

Specific Health ConditionCancer
Head and neck
Diet and Nutrition
Other diet and nutrition disorders
Mental Health
Depression

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD,SA,WA,VIC

Hospital
Sir Charles Gairdner Hospital - Nedlands

Hospital
The Royal Adelaide Hospital - Adelaide

Hospital
Peter MacCallum Cancer Institute - East Melbourne

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
Mater Adult Hospital - South Brisbane

Hospital
Toowoomba Hospital - Toowoomba

Hospital
St Andrew's Toowoomba Hospital - Toowoomba

Postcode
4350 - Toowoomba

Postcode
4350 - Rockville

Postcode
6009 - Nedlands

Postcode
3002 - East Melbourne

Postcode
5000 - Adelaide

Postcode
4101 - South Brisbane

Postcode
4102 - Woolloongabba

Anticipated date of first participant enrolment8/04/2013

Anticipated date of last participant enrolment27/03/2015

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Pathologically confirmed diagnosis of cancer involving the Nasopharynx, Oropharynx, Oral Cavity, Larynx, or Hypopharynx requiring definitive or postoperative radiotherapy with curative intent

Regional nodal irradiation included in PTV1 (as a minimum ipsilateral levels II-III)

Receiving a prescribed dose of at least 60 Gy

Definitive or post operative adjuvant Radiotherapy intent permitted

Radiotherapy as sole modality or Chemoradiation (including neoadjuvant and adjuvant chemotherapy) permitted

Participation of patients on other clinical trial protocols permitted provided these trials are likely to continue throughout the period of this study. This will ensure that patients in both the control and intervention group are exposed to similar radiotherapy treatments.

> 18 years of age

Available for follow-up for at least 6 months

Life expectancy greater than 6 months

Written informed consent

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Patient not meeting the eligibility criteria

Patient cannot communicate in English

Patient with organic brain diseases impairing ability to complete questionnaires satisfactorily

Patients where significant oral or pharyngeal mucositis is not expected as a complication of radiotherapy treatment (patients with T1 / T2 glottic carcinoma undergoing small field radiotherapy or T1/T2 tonsil cancer undergoing unilateral treatment are not eligible)
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: University of Newcastle
Primary Sponsor Address: Professor Amanda Baker, School of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, 2308
Primary Sponsor Country: Australia

Trial IDACTRN12613000320752

UTNU1111-1137-6830

Contact person for information and recruitmentDr
Alison Beck
Trial Coordinator, Priority Research Centre for Translational Neuroscience and Mental Health, University of Newcastle, PO Box 833, Newcastle, NSW 2300
+61 2 4033 5039
+61 2 4033 5692
Further information iconAlison.Beck@newcastle.edu.au
Australia

TROG 12.01 A Randomised Trial of Weekly Cetuximab and Radiation versus Weekly Cisplatin and Radiation in Good Prognosis Locoregionally Advanced HPV-Associated Oropharyngeal Squamous Cell Carcinoma

Print record Print record
Trial Information

Trial summary

This study aims to compare radiation treatment combined with either cetuximab or cisplatin in patients with locoregionally advanced HPV positive oropharyngeal squamous cell carcinoma (OPSCC) (located at the base of tongue or tonsil)

Who is it for?
You may be eligible to join this study if you are aged 18 years or more, and have been diagnosed with locoregionally advanced HPV positive oropharyngeal squamous cell carcinoma (OPSCC). You should not have received any prior treatment for this cancer.

Trial details;
Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will receive radiation treatment 5 days a week over 7 weeks, in conjunction with weekly doses of a drug called cetuximab. This drug is administered intravenously, i.e. directly into the vein. 

Participants in the other group will receive radiation treatment 5 days a week over 7 weeks in combination with the chemotherapy drug cisplatin, which is also administered intravenously.

Participants will be assessed weekly during treatment, then at 1, 3, 5, 9, 13 weeks post-treatment and at months 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 42, 48, 54, and 60 post-completion of treatment. Assessments will involve blood tests, questionnaires, clinical examination, hearing tests, swallowing tests, and radiological examination. The main research question being answered is whether those treated with weekly cetuximab and conventionally fractionated radiotherapy will experience less acute symptom severity than patients receiving weekly cisplatin and conventionally fractionated radiotherapy.

Broad Health ConditionHPV positive Oropharyngeal Squamous Cell Carcinoma (OPSCC)

Specific Health ConditionCancer
Head and neck

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,QLD,SA,WA,VIC

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
Royal Brisbane & Womens Hospital - Herston

Hospital
Calvary Mater Newcastle - Waratah

Hospital
Peter MacCallum Cancer Institute - East Melbourne

Hospital
The Canberra Hospital - Garran

Hospital
Liverpool Hospital - Liverpool

Hospital
Riverina Cancer Care Centre - Wagga Wagga

Hospital
The Chris O’Brien Lifehouse - Camperdown

Hospital
Westmead Hospital - Westmead

Hospital
The Townsville Hospital - Douglas

Hospital
St George Hospital - Kogarah

Hospital
Flinders Medical Centre - Bedford Park

Hospital
Austin Health - Austin Hospital - Heidelberg

Hospital
Sir Charles Gairdner Hospital - Nedlands

Hospital
Gold Coast Hospital - Southport

Trial location outside Australia

Country
New Zealand

State
Auckland

Country
New Zealand

State
Palmerston North

Anticipated date of first participant enrolment1/05/2013

Anticipated date of last participant enrolment1/06/2018

Phase of TrialPhase 3

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Aged 18 years or older
2. Has provided written Informed Consent for participation in this trial 
3. Histologically confirmed squamous cell carcinoma of the oropharynx with p16 positive status confirmed locally by immunohistochemistry 
4. Stage III (excluding T1-2N1) or stage IV (excluding T4, N3, and distant metastasis) if smoking history of < /=10 pack years. If > 10 pack years nodal disease must be N0 – N2a. 
5. If an excisional biopsy has been performed, patients remain eligible for the study provided there is clinically measurable disease prior to commencing RT. The residual disease should still meet the stage criteria required for the trial e.g. excisional biopsy of a node with residual T3 primary, or tonsillectomy for T1 primary with residual > N2a nodes.
6. No prior treatment for oropharyngeal cancer
7. Adequate haematological, renal, and hepatic function as defined by, 
a)  Absolute neutrophil count (ANC, segs + bands) > /= 1.5 x 109/L
b) Platelet count > /= 100 x 109/L
c) Total bilirubin < /= 1.5 x upper normal limit 
d) ALT  < /= 2.5 x upper normal limit 
e) Calculated creatinine clearance (Cockcroft-Gault formula) or isotopic GFR > 55ml/min 
8. ECOG performance status score of 0-1 
9. Participants capable of childbearing are using adequate contraception and intend to continue use of contraception for at least 6 months following completion of treatment
10. Negative pregnancy test within 72 hours prior to randomisation of women who are of childbearing potential
11. Suitable for follow-up for at least 24 months as per trial protocol.
12. Sufficient proficiency in English, cognitive capacity and willingness to complete questionnaires

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. History of unknown primary of the head and neck
2. T4, N3 or distant metastases
3. Smoking history >10 pack years with N2b or c nodal status
4. Women who are pregnant or lactating.
5. Previous radiotherapy to the area to be treated (excluding superficial radiotherapy for a cutaneous malignancy)
6. Previous cisplatin or carboplatin chemotherapy
7. Prior EGFR targeted therapy of any kind
8. Primary surgery to the affected area (excisional biopsy allowed)
9. Peripheral neuropathy > /= grade 2 (CTCAE v4.0)
10. Sensori-neural hearing impairment >= grade 2 (CTCAE v4.0, hearing impaired, not enrolled on a monitoring program) which may be exacerbated by cisplatin (Audiometric abnormalities without corresponding clinical deafness will not be grounds for exclusion) 
11. Tinnitus > /= grade 2 (CTCAE v4.0)
12. History of interstitial lung disease or evidence of interstitial lung disease on pre-registration CT
13. History of myocardial infarction within 12 months prior to study entry, uncontrolled congestive heart failure, unstable angina, active cardiomyopathy, unstable arrhythmia, uncontrolled psychotic disorders, active serious infections, active peptic ulcer disease, immunosuppression due to post-organ transplantation or use of immunosuppressants for autoimmune disorders
14. Patients known to be HIV positive
15. Other cancer that was diagnosed:
a) more than 5 years prior to current diagnosis with (i) subsequent evidence of disease recurrence or (ii) clinical expectation of recurrence is greater than 10% or
b) within 5 years of the current diagnosis, with the exception of successfully treated basal cell or squamous cell skin carcinoma, in situ melanoma, or carcinoma in situ of the cervix
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Trans-Tasman Radiation Oncology Group
Primary Sponsor Address: TROG Central Office PO Box 88 Waratah NSW 2298
Primary Sponsor Country: Australia

Trial websitewww.trog.com.au

Trial IDACTRN12613000279729

Contact person for information and recruitmentMs
Anetta Matera
Peter MacCallum Cancer Centre Locked Bag No 1, A’Beckett St, Melbourne, VIC 8006, Australia.
+61 3 9656 3661

Further information iconAnetta.Matera@petermac.org
Australia

Phase I pilot of a Mindfulness-Based Stress Reduction intervention for Head and Neck Cancer patients receiving treatment of curative intent.

Print record Print record
Trial Information

Trial summary

This research project is a Phase I pilot study which aims to develop and manualise a version of Mindfulness-Based Stress Reduction (MBSR) suitable for individual administration to Head and Neck Cancer (HNC) patients during the active stage of cancer treatment of curative intent. Members of our research team have previously demonstrated that HNC patients receiving treatment of curative intent reach a threshold of clinically significant distress both immediately prior to and during treatment, and also experience a decline in health-related quality of life (HRQoL) in the weeks following treatment. These findings are consistent with previous research which has shown that patients experience high levels of distress following the chronic functional impairment and disfigurement that is a common outcome of treatment for HNCs, and points to the need for effective psychological interventions to assist coping during and following treatment for HNCs. MBSR, as demonstrated by another of our team members, has shown success in reducing psychological distress associated with other forms of cancer, including breast and prostate cancer. As no reported studies exist that use MBSR with HNC patients, we intend to evaluate whether MBSR may be suitable for use in this population. We also aim to establish whether participants’ levels of psychological distress, HRQoL, mindfulness attention and awareness, intrusive cognitions, self-compassion and shame can be effectively measured in this setting. We plan to examine the feasibility (assessed through the feasibility of and compliance and fidelity to the intervention) and acceptability of MBSR therapy to participants through examining the accrual and attrition rates for this pilot study, and further explore participant’s experiences, both positive and negative, of MBSR through a post-intervention semi-structured interview. Finally, we aim to see whether MBSR delivered by a suitably qualified and experienced mental health professional is applicable and feasible for use in a hospital context.

Broad Health ConditionHead and Neck Cancer
Psychosocial distress

Specific Health ConditionCancer
Head and neck
Mental Health
Depression
Mental Health
Anxiety

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
Peter MacCallum Cancer Institute - East Melbourne

Postcode
3002 - East Melbourne

Anticipated date of first participant enrolment16/01/2013

Anticipated date of last participant enrolment3/01/2014

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Eligibility for participation in this study is a diagnosis for the first time of a potentially curable cancer in the head and neck region (excluding cancers exclusively involving skin), where the patient has agreed to undertake cancer treatment with curative intent the recruiting site, Peter MacCallum Cancer Centre East Melbourne. Eligibility of patients to participate will be evaluated by oncologists and/or the nurse co-coordinator. Participants must also be aged 18 years or older at the time of recruitment to be considered for inclusion in this study.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

A patient will not be eligible for this study if they are being actively treated for another cancer; or another severely debilitating illness, cannot speak or understand English adequately, or have been diagnosed with an intellectual disability, dementia or active psychotic illness. Participants who have been recruited into other time-intensive studies at the recruiting site, Peter MacCallum Cancer Centre, will not be approached to participate in this study.
Contact details and further information

Sponsor Primary Sponsor Type: Charities/Societies/Foundations
Primary Sponsor Name: Beyond Blue Limited (beyondblue)
Primary Sponsor Address: PO Box 6100 Hawthorn West VIC 3122
Primary Sponsor Country: Australia

Trial IDACTRN12613000271707

Contact person for information and recruitmentDr
Jeremy Couper
Locked Bag 1 A'Beckett Street Victoria 8006
+61 3 96561828
+61 3 96561095
Further information iconjeremy.couper@petermac.org
Australia

Early tube feeding in head and neck cancer

Print record Print record
Trial Information

Trial summary

This study aims to compare the outcome of early tube feeding compared to commencement of feeding as per current standard practice in patients undergoing gastrostomy prior to treatment for head and neck cancer. 

Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with head and neck cancer, and have been referred for a preventive gastrostomy (insertion of feeding tube into the stomach) prior to treatment for your cancer. 

Trial details Participants in this trial will be randomly (by chance) allocated to one of two treatment groups. Participants in one group will commence two supplementary feeds per day at the time of feeding tube insertion (gastrostomy). These feeds will be in addition to the patient's usual dietary intake and will continue throughout cancer treatment. Participants in the other group will receive standard care. This involves water flushes via the gastrostomy throughout cancer treatment and feeds will be commenced by the dietitian as clinically indicated during treatment. 

Participants will be assessed at baseline and 3 months post completion of treatment in order to determine impact on nutrition outcomes, quality of life and clinical outcomes.

Broad Health ConditionHead and neck cancer
Malnutrition

Specific Health ConditionCancer
Head and neck
Diet and Nutrition
Other diet and nutrition disorders

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Royal Brisbane & Womens Hospital - Herston

Postcode
4029 - Royal Brisbane Hospital

Anticipated date of first participant enrolment1/07/2012

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Diagnosed with head and neck cancer
AND
Referred for prophylactic gastrostomy prior to treatment

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

patients with severe malnutrition at diagnosis
OR
patients with moderate malnutrition and severe dysphagia at diagnosis (requiring puree/liquid diets)
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Teresa Brown
Primary Sponsor Address: Dept Nutrition and Dietetics, RBWH Level 2 James Mayne Building Butterfield Street Herston QLD 4029
Primary Sponsor Country: Australia

Trial IDACTRN12612000579897

UTNU1111-1131-0924

Contact person for information and recruitmentMs
Teresa Brown
Dept Nutrition and Dietetics Level 2 James Mayne Building, RBWH Butterfield Street Herston QLD 4029
+617 3646 7997
+617 3646 1874
Further information iconteresa_brown@health.qld.gov.au
Australia