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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
Sponsor: Centre Hospitalier Universitaire Dijon
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
Conditions
Interventions
"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
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 ASSESSMENT
blood sample ACE markers
Questionnaires
Quality of life questionnaires (QLQ-C30 ; EQ-5D-5L ; GPAQ)
Thoracic-abdomino-pelvic scan or MRI
Thoracic-abdomino-pelvic scan or MRI
Locations (1)
Chu Dijon Bourgogne
Dijon, France