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Randomized Trial of Plasma ctDNA Methylation-Guided Adjuvant Therapy in T4N0 and Low-Risk Stage III Colorectal Cancer

NCT07562503 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2026-05-01

No results posted yet for this study

Summary

The patient (T4N0 or low-risk stage III) will be randomly assigned to either the control group (FOLFOX/CAPOX for 3 months) or the intervention group (FOLFOX/CAPOX for 6 months or FOLFOX/CAPOX for 3 months followed by FOLFIRI/CAPIRI for 3 months) to receive adjuvant therapy. Venous blood samples (8-16 mL) will be collected at 1 month, 3 months, and 6 months after surgery for dynamic monitoring of plasma ctDNA.

Conditions

Interventions

DRUG

CAPEOX regimen

CAPEOX regimen for 3 months

DRUG

CAPEOX regimen

6 months or FOLFOX/CAPOX for 3 months followed by FOLFIRI/CAPIRI for 3 months

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07562503 on ClinicalTrials.gov