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Chemotherapy for Stage III Colon Cancer Based on Residual Disease

This study is for people with Stage III colon cancer who have had surgery. It aims to figure out the best chemotherapy (drug treatment) plan based on whether tiny amounts of cancer cells (called circulating tumor DNA or ctDNA) are still in your body after surgery. You would receive a Signatera test to check for ctDNA. Depending on the results, you might receive mFOLFOX6, CAPOX, or mFOLFIRINOX chemotherapy. The study will look at how long it takes for ctDNA to be detected and how long people live without their cancer returning. You must be at least 18 years old and have Stage IIB, IIC, or III colon cancer that has been completely removed by surgery.

Study design
This interventional study plans to enroll 1912 participants. It is evaluating different chemotherapy regimens based on ctDNA test results.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 3 years to measure ctDNA status and up to 5 years to track disease-free survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05174169

Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease

Recruiting
PHASE2Ages 18+InterventionalTreatment
NRG Oncology
~1,912 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:Signatera testmFOLFOX6 3-6 monthCAPOX 3 monthmFOLFIRINOXmFOLFOX6 6 monthCAPOX 6 month

At a glance

Recruiting sites
953 of 1066 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
ctDNA positive status (TTPos)
Measured over Time from randomization to the first TTPos event, a maximum of 3 years
+1 more outcome measured

Conditions

Stage III Colon Cancer

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Where it's being run

1066 sites across 57 states
California113
Ohio93
Illinois78
Wisconsin72
Pennsylvania68
Michigan60
Minnesota42
Colorado34

Who to contact

Judy Langer
[email protected]
412-339-5300
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3;
Participants with benign ethnic neutropenia (BEN): ANC less than 1300 mm3 are eligible.
BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups.
Platelet count must be greater than or equal to 100,000/mm3; and
Hemoglobin must be greater than or equal to 9 g/dL.
total bilirubin must be less than or equal to ULN (upper limit of normal) for the lab and
alkaline phosphatase must be less than 2.5 x ULN for the lab; and
AST and ALT must be less than 2.5 x ULN for the lab.
Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3;
Participants with benign ethnic neutropenia (BEN): ANC less than 1300 mm3 are eligible.
BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups.
Platelet count must be greater than or equal to 100,000/mm3; and
Hemoglobin must be greater than or equal to 9 g/dL.
total bilirubin must be less than or equal to ULN (upper limit of normal) for the lab and
alkaline phosphatase must be less than 2.5 x ULN for the lab; and
AST and ALT must be less than 2.5 x ULN for the lab.

What this trial measures

  • ctDNA positive status (TTPos)Time from randomization to the first TTPos event, a maximum of 3 years

    TTPos is defined as time from randomization until ctDNA positive event: TTPos events are first ctDNA positive result after randomization for the immediate adjuvant chemo arm (Arm 1), 2nd ctDNA positive result after randomization for the delayed adjuvant chemo (Arm 2) and recurrence without a positive ctDNA result for both arms.

  • Disease-Free Survival (DFS)Time from randomization to disease-free survival event, a maximum of 5 years]

    Time from randomization to first disease-free survival event (recurrence, second primary colorectal cancer or death from any cause).