Trial purpose
Cancer treatment
Tumor type
Lower gastrointestinal tract
Age
18 - 75
Clinical summary
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, 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.
Conditions
This trial is treating patients with Colon and Rectum Cancer
Eligibility
Inclusion
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.
Exclusion
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.
Inclusion
- Your cancer has not spread to other parts of the body (localised).
- You have been diagnosed with cancer, but have not received any treatment.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Walter and Eliza Hall Institute
Scientific Title
Circulating tumour DNA (ctDNA) analysis informing adjuvant chemotherapy in Stage II Colon Cancer
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