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NOT YET RECRUITING
NCT06197425
PHASE3

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

Sponsor: Centre Hospitalier Universitaire Dijon

View on ClinicalTrials.gov

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

Official title: Phase III Multicentric, Open-label, Randomized Study to Investigate the Efficacy of Chemotherapy in Patients With Positive ctDNA After Surgery and Adjuvant Chemotherapy for a Stage III Colorectal Cancer (PRODIGE 88)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1660

Start Date

2024-01

Completion Date

2030-01

Last Updated

2024-01-09

Healthy Volunteers

No

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

Locations (1)

Chu Dijon Bourgogne

Dijon, France