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Clinical Trials/NCT00208260
NCT00208260
Completed
Phase 2

Randomized Phase II Trial Followed by Phase III Trial With Molecular Biology Study, Comparing a Standard Bi-therapy vs 3 Arms of Intensified Chemotherapy in Patients With Unresectable or Not Optimally Resectable Colorectal Cancer Liver Metastases.

Institut du Cancer de Montpellier - Val d'Aurelle1 site in 1 country124 target enrollmentApril 1, 2004
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ConditionsColorectal CancerLiver MetastasesChemotherapy
InterventionsFOLFIRIFOLFOX-4FOLFIRI-HDFOLFOX-7FOLFIRINOX
DrugsFOLFIRIFOLFOX-4FOLFIRI-HDFOLFOX-7FOLFIRINOX

Overview

Phase
Phase 2
Intervention
FOLFIRI
Conditions
Colorectal Cancer
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Enrollment
124
Locations
1
Primary Endpoint
Response
Status
Completed
Last Updated
2 months ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

Randomized, open label, multicentre phase II trial followed by phase III comparing overall survival after having selected the best experimental arm.

Registry
clinicaltrials.gov
Start Date
April 1, 2004
End Date
August 1, 2007
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle

Eligibility Criteria

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

  • Not provided

Arms & Interventions

A

FOLFIRI

Intervention: FOLFIRI

B

FOLFOX-4

Intervention: FOLFOX-4

C

FOLFIRI-HD

Intervention: FOLFIRI-HD

D

FOLFOX-7

Intervention: FOLFOX-7

E

FOLFIRINOX

Intervention: FOLFIRINOX

Outcomes

Primary Outcomes

Response

Time Frame: end of chemotherapy

Secondary Outcomes

  • Safety(during study treatment)
  • Survival(2 years)
  • Secondary resection(surgery after chemotherapy)

Study Sites (1)

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