RecruitingNot ApplicableNCT06204484

MRD-guided Deferred Adjuvant Therapy in Resectable Early-stage Colon Cancer

The Effectiveness of Deferred Adjuvant Therapy Guided by Dynamic Monitoring Minimal Residue Disease in Resectable High-risk Stage II and Low-risk Stage III Colon Cancer: an Open-label, Multicenter, Phase II Clinical Study

Sponsor

Sun Yat-sen University

Enrollment

349 participants

Start Date

Jul 26, 2023

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer

Summary

The aim of this clinical trial is to test whether minimal residual disease (MRD) status detected by circulating tumor DNA (ctDNA) could be used to guide precision therapy of post-surgery in colon cancer. The colon cancers are intended for resectable colon cancer of high-risk stage II and low-risk stage III status. The main questions it aims to answer are: 1. Whether patients with MRD negative status could benefit from deferred adjuvant therapy. 2. Whether patients with MRD positive status need intensive adjuvant therapy. The qualified participants will go through two different randomized groups according to the post-surgery 1-month MRD status. In MRD negative groups, participants will be divided into standard adjuvant therapy groups and deferred adjuvant therapy groups at 1:2 ratios. In MRD positive groups, participants will be divided into standard adjuvant therapy groups and intensive adjuvant therapy groups at 1:2 ratios. All the patients will receive MRD detection every 3 months and radiological evaluation every 6 months up to 3 years, and survival follow-up up to 5 years.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial uses circulating tumor DNA (ctDNA) — tiny fragments of cancer DNA detectable in a blood test — to guide whether people with early-stage colon cancer need chemotherapy after surgery, potentially sparing those at lower risk from unnecessary treatment. **You may be eligible if...** - You have been diagnosed with stage II high-risk or stage III low-risk colon cancer (not a highly unstable tumor type called MSI-H) - You are between 18 and 70 years old - You are in good general health (ECOG 0–1) - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - Your tumor is the MSI-H type (a specific genetic marker) - Your cancer has spread beyond the colon - You have received any prior chemotherapy for this cancer - Your blood counts or organ function do not meet minimum levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCAPEOX adjuvant therapy

In MRD-/+ standard therapy groups, patients will receive 3-month CAPEOX therapy, regardless of the MRD status.

OTHERdeferred CAPEOX adjuvant therapy

In MRD-negative deferred adjuvant therapy group, patients won't get the standard CAPEOX adjuvant therapy at first. When MRD negative status turns to positive status, the 3-month CAPEOX therapy will be arranged.

OTHERmFOLFOXIRI intensive adjuvant therapy

In the MRD+ intensive standard therapy group, which represents a high risk of recurrence, patients will receive 3-month mFOLFOXIRI intensive therapy, instead of the CAPEOX standard adjuvant therapy.