Clinical Trial Details

Adjuvant chemotherapy with gemcitabine and cisplatin compared to standard of care after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma (ACTICCA-1 trial)

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Trial Information

Broad Health Condition Cancer

Specific Health ConditionBiliary tree (gall bladder and bile duct)

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State

Bankstown-Lidcombe Hospital - Bankstown
Royal Brisbane & Womens Hospital - Herston
Flinders Medical Centre - Bedford Park
Nepean Hospital - Kingswood
Calvary Mater Newcastle - Waratah
The Townsville Hospital - Douglas
Prince of Wales Hospital - Randwick
Princess Alexandra Hospital - Woolloongabba
Sir Charles Gairdner Hospital - Nedlands
St John of God Hospital, Subiaco - Subiaco
St George Hospital - Kogarah
Fiona Stanley Hospital - Murdoch

2747 - Kingswood
2298 - Waratah
4814 - Douglas
2031 - Randwick
4102 - Woolloongabba
6009 - Nedlands
6008 - Subiaco
2217 - Kogarah
6150 - Murdoch

Trial location outside Australia
United Kingdom

Anticipated date of first participant enrolment1/12/2015

Anticipated date of last participant enrolment1/12/2015

Phase of TrialPhase 3

Has the study received ethics approval?Further information iconApproved

Trial summary

The purpose of this study is to determine whether or not treating patients with cisplatin and gemcitabine chemotherapy helps reduce the risk of cancer returning. 
Who is it for?
ACTICCA-1 is a clinical research study for people who have a cancer of the biliary tract (cancer of the gall bladder or bile duct, also known as cholangiocarcinoma in medical terms) which has been removed in an operation.
Study details
These drugs are being tested as they have been shown to be the most effective chemotherapy combination in more advanced cases of biliary tract cancer, where the disease is inoperable or has spread to other areas of the body.
This is an international investigator initiated study called ACTICCA-1, which is being led by the University Medical Centre Hamburg- Eppendorf in Germany and conducted in Australia by the Australasian Gastro-Intestinal Trials Group (AGITG) in collaboration with the National Health and Medical Research Centre Clinical Trials Centre (NHMRC CTC), University of Sydney.
The study involves randomly allocating participants to receive either chemotherapy with cisplatin and gemcitabine or the current standard of care (capecitabine). The drugs used in this study are approved in Australia to treat various cancers, however they do not have a specific listing by the Australian Therapeutics Goods Administration (TGA) for biliary tract cancer
The total duration of the study is 5 years. 
It is hoped that the findings of this study will provide details on whether giving cisplatin and gemcitabine chemotherapy following surgery for cancer of the biliary tract is a safe and effective treatment to reduce the chance of disease progression and increase survival time and quality of life.

Key inclusion criteria

* Histologically confirmed adenocarcinoma of biliary tract (intrahepatic, hilar or extrahepatic cholangiocarcinoma or muscle invasive gallbladder carcinoma) after radical surgical therapy with macroscopically complete resection (mixed tumour entities (HCC/CCA) are excluded)
* Macroscopically complete resection (R0/1) within 6 (-16) weeks before scheduled start of chemotherapy
*ECOG 0-1
*Age greater than 18 years
* Adequate hematologic function: ANC greater than or equal to 1.5 x 10*9/L, platelets greater than or equal to 100 x 10*9/L, haemoglobin greater than or equal to 9 grams/dl or greater than or equal to 5.59 mmol/L
* Adequate liver function as measured by serum transaminases (AST and ALT) less than or equal to 5xULN and bilirubin less than or equal to 3xULN
*Adequate renal function, ie. serum creatinine less than or equal to 1.5xULN, glomerular filtration rate greater than or equal to 60mL/min (MDRD)
* No active uncontrolled infection, except chronic viral hepatitis under antiviral therapy
* No concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to randomisation
* Negative serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women less than 1 year after the onset of menopause (Note: a negative test has to be reconfirmed by a urine test, should the 7 day window be exceeded)
* Written informed consent

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

* Prior chemotherapy for biliary tract cancer
* Previous malignancy within 3 years or concomitant malignancy, except: those with a 5 year overall survival rate of more than 90% e.g non-melanomatous skin cancer or adequately treated in-situ cervical cancer 
* Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction in the last 3 months, significant arrhythmia
* Presence of psychiatric disorder precluding understanding of information of trial related topics and giving informed consent
* Serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial
* Fertile women (less than 1 year after last menstruation) and procreative men unwilling and unable to use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)
* Pregnancy or lactation
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Australasian Gastro-Intestinal Trials Group
Primary Sponsor Address: GI Cancer Institute Lifehouse, Level 6 119-143 Missenden Road Camperdown NSW 2050
Primary Sponsor Country: Australia

Trial IDACTRN12615001283561

Contact person for information and recruitmentMs
ACTICCA-1 Trial Coordinator
Lifehouse Level 6 119-143 Missenden Road Camperdown NSW 2050
+612 9562 5000

Further information