Platform study of circulating tumor DNA directed adjuvant chemotherapy in colon cancer (CLAUDIA colon cancer, KCSG CO22-12)
Abstract
BACKGROUND: Tumor-informed circulating tumor DNA (ctDNA) analysis allows for the sensitive detection of minimal residual disease (MRD) and has the potential to enhance patient stratification for adjuvant chemotherapy. We hypothesize that intensifying adjuvant chemotherapy in colon cancer patients with postoperative MRD positivity may reduce recurrence and improve survival outcomes. METHODS: This multi-center platform trial (NCT05534087) consists of a prospective observational study (Part 1) and an interventional randomized trial (Part 2). In Part 1, approximately 1,200 patients with colon cancer will be screened for MRD at 3–6 weeks postoperatively using a tumor-informed, hybrid-capture-based ctDNA MRD assay that tracks up to 100 patient-specific somatic variants identified through tumor whole-exome sequencing. Key eligibility criteria includes: age ≥ 19 years, ≤ 6 weeks post-curative resection, pathological diagnosis of colon adenocarcinoma, stage III or stage II with high-risk features requiring adjuvant chemotherapy with FOLFOX/CAPOX, and no macroscopic residual disease. All patients in Part 1 will complete 3 months of standard adjuvant FOLFOX/CAPOX while awaiting MRD results. Patients with MRD positivity will be screened for the Part 2 clinical trial following the completion of the initial 3 months of treatment titled “Randomized Controlled Phase III Trial of Treatment Intensification in Stage II–III Colon Cancer Patients with Positive MRD after Curative Resection.”…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,200 participants or records.
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