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Investigate the Efficacy of Chemotherapy in Patients With Positive ctDNA After Surgery and Adjuvant Chemotherapy for a Stage III Colorectal Cancer

NCT06197425 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1660

Last updated 2026-05-22

No results posted yet for this study

Summary

Phase III multicentric, open-label, randomized study

The main objective is to assess the efficacy on time to disease recurrence (TTR) of treating minimal residual disease diagnosed by the presence of ctDNA after full treatment (surgery + chemotherapy) in stage III or high-risk stage II colon or upper rectum adenocarcinoma

Conditions

  • Colon or Upper Rectum Adenocarcinoma

Interventions

DRUG

"FOLFIRI" cures

(Irinotecan 180 mg/m2, leucovorine 400mg/m2, 5FU bolus 400 mg/m2, 5FU continuous infusion 2400 mg/m2) every 14 days for 6 months or until disease progression on imaging

DRUG

Trifluridine cures

Trifluridine tipiracil 35 mg/m2 bid during 5 days/w on week 1 and 2 every 4 weeks, for 6 months or until disease progression on imaging

BIOLOGICAL

BIOLOGICAL ASSESSMENT

blood sample ACE markers

OTHER

Questionnaires

Quality of life questionnaires (QLQ-C30 ; EQ-5D-5L ; GPAQ)

OTHER

Thoracic-abdomino-pelvic scan or MRI

Thoracic-abdomino-pelvic scan or MRI

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Dijon

    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
2026-05-07
Primary Completion
2032-05-31
Completion
2032-05-31

Countries

  • France

Study Locations

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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 NCT06197425 on ClinicalTrials.gov