Actively Recruiting
Tracking Mutations in Cell Free Tumour DNA to Predict Relapse in Early Colorectal Cancer
Led by Royal Marsden NHS Foundation Trust · Updated on 2024-06-14
1000
Participants Needed
71
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with newly diagnosed stage I, II, and III colorectal cancer CRC to understand how circulating tumor DNA ctDNA in the blood can predict disease relapse. The study evaluates whether using ctDNA to guide adjuvant chemotherapy decisions after surgery is as effective as standard chemotherapy, aiming to reduce unnecessary treatments and side effects. This multi-center, prospective research includes both observational and randomized components to better manage early-stage CRC. The study has two parts Part B focuses on collecting tumor tissue, serial blood samples, and clinical data to detect minimal residual disease MRD using ctDNA after curative surgery. Part C is a randomized trial comparing ctDNA-guided adjuvant chemotherapy versus standard care in patients with high-risk stage II or III CRC. Patients are randomized post-surgery to either standard chemotherapy or a ctDNA-guided approach where those testing negative for ctDNA may receive less chemotherapy. Participants will undergo regular blood sampling and clinical assessments to monitor ctDNA levels and disease status. Researchers will measure outcomes such as 3-year disease-free survival and the relationship between ctDNA detection and treatment response over several years. The study includes follow-up periods of 4 to 8 years to evaluate long-term outcomes and safety. Participants need to consent, adhere to follow-up schedules, and be suitable for chemotherapy if randomized to Part C.
CONDITIONS
Brief Title
Tracking Mutations in Cell Free Tumour DNA to Predict Relapse in Early Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- New diagnosis of histologically confirmed colorectal cancer scheduled for surgery with curative intent and no metastatic disease visible on scans
- Age 18 years or older
- Ability to give informed consent
- Able to follow the study's follow-up schedule
- For Part C: Diagnosis of high-risk stage II or stage III colon or rectal cancer treated with surgery alone or locally advanced stage III rectal cancer treated with neoadjuvant chemoradiotherapy
- Fully surgically removed tumor with clear margins
- Adequate organ function and blood counts
- No major post-operative complications preventing chemotherapy
- Suitable for adjuvant chemotherapy as assessed by oncology team
- ECOG performance status between 0 and 2
You will not qualify if you...
- Scheduled to receive neoadjuvant chemotherapy (except chemoradiotherapy for rectal cancer)
- History of other cancers within 5 years except certain non-invasive or cured cancers
- Major post-operative complications or clinical conditions contraindicating chemotherapy
- Not planned to receive adjuvant chemotherapy (for Part C)
- Known allergy or contraindication to planned chemotherapy drugs (CAPOX or capecitabine)
- Planned treatment with 5-Fluorouracil based chemotherapy (for Part C)
Research Team
H
Hsiang-Chi Chen, MSc
S
Susie Slater, Dr
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