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Intensified Chemotherapy in CRC After Resection of Liver Metastases

This study has been completed.
Chugai Pharmaceutical
Information provided by:
Institut du Cancer de Montpellier - Val d'Aurelle Identifier:
First received: September 13, 2005
Last updated: June 15, 2010
Last verified: June 2010
Randomized, open label, multicentre phase II trial followed by phase III comparing overall survival after having selected the best experimental arm.

Condition Intervention Phase
Colorectal Cancer
Liver Metastases
Drug: FOLFOX-4
Drug: FOLFOX-7
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Institut du Cancer de Montpellier - Val d'Aurelle:

Primary Outcome Measures:
  • Response [ Time Frame: end of chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: during study treatment ] [ Designated as safety issue: Yes ]
  • Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Secondary resection [ Time Frame: surgery after chemotherapy ] [ Designated as safety issue: No ]

Enrollment: 124
Study Start Date: April 2004
Study Completion Date: August 2007
Arms Assigned Interventions
Active Comparator: A
FOLFIRI : Irinotecan : 180 mg/m² 90 min continuous perfusion during levorin d1 every 2 weeks
Active Comparator: B
Drug: FOLFOX-4
FOLFOX 4 : Oxaliplatine : 85 mg/m² 2h continuous perfusion during levorin d1 every 2weeks
Experimental: C
High Dose FOLFIRI : Irinotecan : 260 mg/m² in 90min continuous perfusion during levorin d1 every 2 weeks
Experimental: D
Drug: FOLFOX-7
FOLFOX 7 : Oxaliplatine : 130 mg/m² in 2h continuous perfusion during levorin d1 every 2 weeks
Experimental: E
FOLFIRINOX : Oxaliplatine : 85 mg/m² 2h continuous perfusion followed by 1H rest followed by 90 min continuous perfusion of irinotecan : 180 mg/m² during levorin d1 every 2 weeks


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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:

  Contacts and Locations
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Please refer to this study by its identifier: NCT00208260

CRLC Val d'Aurelle
Montpellier, France, 34298
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Chugai Pharmaceutical
Principal Investigator: Marc YCHOU, MD, PhD CRLC Val d'Aurelle
Study Chair: Michel RIVOIRE, MD CRLC Leon Berard - Lyon
  More Information Identifier: NCT00208260     History of Changes
Other Study ID Numbers: METHEP/2004/22 
Study First Received: September 13, 2005
Last Updated: June 15, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases processed this record on October 25, 2016