Australian Clinical Trials

Broad Health Condition Cancer

Specific Health ConditionBowel - Back passage (rectum) or large bowel (colon)

Trial FocusTreatment

Recruitment Details

Recruitment status
Active, not recruiting

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

Hospital
Royal Melbourne Hospital - City campus - Parkville
Western Hospital - Footscray
The Alfred - Prahran
Austin Health - Austin Hospital - Heidelberg
Barwon Health - Geelong Hospital campus - Geelong
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Border Medical Oncology - Albury
Cabrini Hospital - Malvern - Malvern
The Canberra Hospital - Garran
Box Hill Hospital - Box Hill
Fiona Stanley Hospital - Murdoch
Flinders Medical Centre - Bedford Park
The Chris O’Brien Lifehouse - Camperdown
Monash Medical Centre - Clayton campus - Clayton
Nepean Hospital - Kingswood
Royal Brisbane & Womens Hospital - Herston
Royal Hobart Hospital - Hobart
St John of God Hospital Warrnambool - Warrnambool
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Calvary Mater Newcastle - Waratah
Newcastle Private Hospital - New Lambton Heights
The Northern Hospital - Epping

Postcode
3050 - Parkville
5022 - Henley Beach
3004 - Prahran
3084 - Heidelberg
3220 - Geelong
3550 - Bendigo
3690 - Wodonga
3144 - Malvern
2605 - Garran
3128 - Box Hill
6150 - Murdoch
5042 - Bedford Park
2050 - Camperdown
3168 - Clayton
2747 - Kingswood
4029 - Herston
7000 - Hobart
3280 - Warrnambool
3065 - Fitzroy
2298 - Waratah
2305 - New Lambton Heights
3076 - Epping

Anticipated date of first participant enrolment1/05/2015

Anticipated date of last participant enrolment1/01/2020

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Trial summary

This study will determine the effect of the use of circulating tumour DNA (ctDNA) to guide adjuvant chemotherapy on recurrence-free survival in stage II colon or rectal cancer patients

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 Stage II colon or rectal cancer and have had your cancer curatively resected. 

Study details
Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will have blood samples taken and analysed for circulating tumour DNA (ctDNA) and be treated according to the ctDNA results. Those with positive ctDNA results will receive standard 5FU-based adjuvant chemotherapy (either single agent or combined with oxaliplatin), while those with negative ctDNA will not receive adjuvant chemotherapy. 
Participants in the other group will have a blood sample taken, but the ctDNA result will not be disclosed. Patients in this group will be treated according to standard clinical criteria at the discretion of the treating physician.
Participants who had positive ctDNA results and are being treated with adjuvant chemotherapy will have monthly blood samples taken during treatment to track ctDNA levels. All participants will be followed up 3 monthly for 2 years, then 6 monthly for 3 years through their hospital for a total of five years for disease recurrence and survival.

Key inclusion criteria

1. Subjects with curatively resected stage II (T3-4, N0M0) colon or rectal cancer.
2. Patients with rectal cancer will be eligible unless they have had pre-operative combined chemotherapy or radiotherapy, or are scheduled for post-operative combined chemotherapy and radiotherapy. All rectal cancer patients included in the trial must have had TME type surgery with negative (R0) resection margins.
3. A representative paraffin embedded tumour sample is avaiable for molecular testing.
4. Fit for adjuvant chemotherapy.
5. ECOG performance status 0-2.
6. Patients that are accessible for follow up.
7. CT C/A/P within 8 weeks demonstrating no metastatic disease.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate? No

Key exclusion criteria

1. History of another primary cancer within the last 3 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix.
2. Patients with multiple primary colorectal cancers
3. Patients treated with neoadjuvant chemo-radiation.
4. Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol.