NCT06197425

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

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)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,660 (estimated)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2024-01-01
• Primary completion: 2030-01-01
• Completion: 2030-01-01
• First posted: 2024-01-09
• Last updated: 2024-01-09

Locations

1 site across 1 country: France