A study to evaluate the use of circulating tumour DNA to guide adjuvant chemotherapy on recurrence-free survival in patients with stage II Colon or rectal cancer.

Walter and Eliza Hall Institute0 sites459 target enrollmentApril 27, 2015

Overview

No summary available.

Registry

who.int

Start Date

April 27, 2015

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

Walter and Eliza Hall Institute

•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.

•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.