Intensified Chemotherapy in CRC After Resection of Liver Metastases (NCT00208260) | Clinical Trial Compass
CompletedPhase 2/3
Intensified Chemotherapy in CRC After Resection of Liver Metastases
France124 participantsStarted 2004-04
Plain-language summary
Randomized, open label, multicentre phase II trial followed by phase III comparing overall survival after having selected the best experimental arm.
Who can participate
Age range18 Years – 75 Years
SexALL
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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:
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What they're measuring
1
Response
Timeframe: end of chemotherapy
Trial details
NCT IDNCT00208260
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle