NCT04068103

Circulating Tumor DNA Testing in Predicting Treatment for Patients With Stage IIA Colon Cancer After Surgery

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

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 635 (actual)
• Sponsor: NRG Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To compare the rate of ctDNA clearance in "ctDNA detected" patients treated with or without adjuvant chemotherapy following resection of stage IIA colon cancer. (Phase II) II. To compare recurrence-free survival (RFS) in "ctDNA detected" patients treated with or without adjuvant chemotherapy following resection of stage IIA colon cancer. (Phase III) SECONDARY OBJECTIVES: I. To describe the prevalence of detectable ctDNA in patients with stage IIA colon cancer following surgical resection. II. To estimate time-to-event outcomes (overall survival \[OS\], recurrence-free survival \[RFS\], and time to recurrence \[TTR\]) by ctDNA marker status and treatment for patients with resected stage IIA colon cancer. III. To estimate the rate of compliance with adjuvant chemotherapy and/or active surveillance for patients with resected stage IIA colon cancer.

Conditions

• Colon Adenocarcinoma
• Stage IIA Colon Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Capecitabine	Given PO
DRUG	Fluorouracil	Given IV
DRUG	Leucovorin	Given IV
DRUG	Leucovorin Calcium	Given IV
DRUG	Oxaliplatin	Give IV
OTHER	Patient Observation	Undergo active surveillance

Timeline

• Start date: 2019-12-16
• Primary completion: 2023-06-30
• Completion: 2026-06-21
• First posted: 2019-08-28
• Last updated: 2025-05-07
• Results posted: 2025-04-27

Locations

957 sites across 3 countries: United States, Canada, Puerto Rico

Regulatory

• FDA-regulated device study