Intensified Chemotherapy in CRC After Resection of Liver Metastases
Phase 2
Completed
- Conditions
- Colorectal CancerLiver MetastasesChemotherapy
- Interventions
- Registration Number
- NCT00208260
- Lead Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Brief Summary
Randomized, open label, multicentre phase II trial followed by phase III comparing overall survival after having selected the best experimental arm.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
Inclusion Criteria
- Histologically proven adenocarcinoma of the colon or rectum without previous resection, or clinically asymptomatic (with or without stent)
- Hepatic unresectable metastases R0: due to close vascular contact, or due to liver remaining mass less than 25 to 30 % of functional liver.
- Not optimally resectable metastases
- Extra-hepatic disease will be accepted in case of: asymptomatic primary tumour or tumor requiring no urgent surgery (in less than 3 months); three of less than three lung metastases (thoracic scan diameter less than 2 cm) and potentially respectable.
- Synchronous and metachronous hepatic metastases
- WHO performance status 0-1
- Adjuvant chemotherapy allowed, except oxaliplatin and irinotecan based combination.
- No prior treatment of the liver metastases, whatever.
- Life expectancy equal or more than 3 months
Exclusion Criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A FOLFIRI FOLFIRI B FOLFOX-4 FOLFOX-4 C FOLFIRI-HD FOLFIRI-HD D FOLFOX-7 FOLFOX-7 E FOLFIRINOX FOLFIRINOX
- Primary Outcome Measures
Name Time Method Response end of chemotherapy
- Secondary Outcome Measures
Name Time Method Safety during study treatment Survival 2 years Secondary resection surgery after chemotherapy
Trial Locations
- Locations (1)
CRLC Val d'Aurelle
🇫🇷Montpellier, France