CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 635 enrolled
Drug / intervention
Capecitabine +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04068103
NCT04068103Phase 3Active

Phase II/III Study of Circulating Tumor DNA as a Predictive Biomarker in Adjuvant Chemotherapy in Patients With Stage IIA Colon Cancer (COBRA)

NRG Oncology·interventional·Posted Aug 28, 2019·Updated May 7, 2025

In Brief

A Phase 3 clinical trial evaluating Capecitabine, Fluorouracil, and 4 other interventions for Colon Adenocarcinoma and Stage IIA Colon Cancer AJCC v8. Active but no longer recruiting, targeting 635 participants across 957 sites in 3 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Puerto Rico, United States

Timeline

Phase 3ActiveOverdue
2020202120222023202420252026
First PostedAug 28, 2019
Enrollment StartDec 16, 2019
Primary CompletionJun 30, 2023
Study CompletionJun 21, 2026
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 6.8 years ago

Interventions

Capecitabinedrug

Given PO

Fluorouracildrug

Given IV

Leucovorindrug

Given IV

Leucovorin Calciumdrug

Given IV

Oxaliplatindrug

Give IV

Patient Observationother

Undergo active surveillance