Circulating Tumor DNA Testing in Predicting Treatment for Patients With Stage IIA Colon Cancer After Surgery
Active, enrolledPhase 2, PHASE3Results postedLast updated 7 May 2025
What this trial tests
Phase 2, PHASE3 trial testing Capecitabine in Colon Adenocarcinoma in 635 participants. Participants enrolled and being followed up; not accepting new ones.
18 and older, any sex, with Colon Adenocarcinoma or Stage IIA Colon Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Clearance of Circulating Tumor Deoxyribonucleic Acid (ctDNA) (to Undetectable Levels) for the "Baseline ctDNA Detected" Patient Subset (Phase II)Primary· Baseline up to 6 months
A two by two contingency table of clearance by treatment arm will be created. The one-sided Fisher exact p-value will be used to determine futility based on the rule specified. Degenerate tables where the Fisher p-value cannot be calculated (no patients clear on either arm or all patients clear on both arms) will count as a failure and a recommendation for early termination.
Group
Value
95% CI
Arm I (Blood Stored and Tested for ctDNA Later)
3
Arm II (Blood Tested for ctDNA at Baseline)
1
Arm I (Blood Stored and Tested for ctDNA Later)
4
Arm II (Blood Tested for ctDNA at Baseline)
8
Adverse events — posted to ClinicalTrials.gov
Time frame: AEs assessed during and up to 30 days after therapy, about 28 weeks..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II/III trial studies how well circulating tumor deoxyribonucleic acid (ctDNA) testing in the blood works in predicting treatment for patients with stage IIA colon cancer after surgery. ctDNA are circulating tumor cells that are shed by tumors into the blood. Finding ctDNA in the blood means that there is very likely some small amounts of cancer that remain after surgery. However, this cancer, if detected, cannot be found on other tests usually used to find cancer, as it is too small. Testing for ctDNA levels may help identify patients with colon cancer after surgery who do benefit, and those who do not benefit, from receiving chemotherapy.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NRG Oncology
Last refreshed: 7 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04068103.