Circulating tumour DNA (ctDNA) analysis informing adjuvant chemotherapy in Stage II Colon Cancer

Not Applicable

Active, not recruiting

• Conditions: Patients with the diagnosis of Stage II Colon cancer.; Patients with the diagnosis of stage II rectal cancer; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12615000381583
• Lead Sponsor: Walter and Eliza Hall Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-27
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 459

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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified