NCT06197425View on ClinicalTrials.gov

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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

1,660

Participants

Timeline

Start Date

January 31, 2024

Primary Completion Date

January 31, 2030

Study Completion Date

January 31, 2030

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

Trial Locations (1)

21000

Chu Dijon Bourgogne, Dijon

All Listed Sponsors
lead

Centre Hospitalier Universitaire Dijon

OTHER