Trial reportBMC cancer2025
Platform study of circulating tumor DNA directed adjuvant chemotherapy in colon cancer (CLAUDIA colon cancer, KCSG CO22-12).
Trial report in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05534087 (A Randomized Controlled Phase III Trial of Treatment Intensification in Stage II-III Colon Cancer Patients With Positive MRD During Adjuvant Chemotherapy), which is not on this map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized Controlled Phase III Trial of Treatment Intensification in Stage II-III Colon Cancer Patients With Positive MRD During Adjuvant Chemotherapy
Who cites it
2 citing papers in PubMed.
- Practical integration of ctDNA-defined minimal residual disease in gastrointestinal cancers: testing windows and evidence-aligned management frameworks.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Review
- New Compass for Precision Oncology: Evidence, Challenges, and Prospects of Circulating Tumor DNA in Colorectal Cancer.Cancer control : journal of the Moffitt Cancer CenterReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
Abstract
backgroundTumor-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.
methodsThis 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.” MRD-negative patients are managed at the investigator’s discretion. Part 2 investigates the superiority of an experimental arm (modified FOLFIRINOX for 3 months) compared to a control arm (FOLFOX/CAPOX for 3 months). The primary endpoint of the Part 2 randomized trial is the 3-year disease-free survival (DFS), while secondary endpoints include the 5-year overall survival, 5-year DFS, treatment-related adverse events, treatment compliance, and patient-reported outcomes. A total of 236 patients will be enrolled and randomized in a 1:1 ratio, assuming a hazard ratio of 0.64, 80% power, a two-sided alpha of 0.05, and a 10% dropout rate. DISCUSSION: This trial will evaluate the effect of adjuvant chemotherapy intensification in colon cancer patients who are MRD-positive after curative surgery. This will enable a personalized adjuvant chemotherapy strategy based on postoperative MRD assessment in colon cancer.
trial registrationClinicalTrials.gov: NCT05534087. Clinical Research Information Service: KCT0007644.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.