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Intensified Chemotherapy in CRC After Resection of Liver Metastases

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Sanofi
Chugai Pharmaceutical
Information provided by:
Centre Val d'Aurelle - Paul Lamarque
ClinicalTrials.gov Identifier:
NCT00208260
First received: September 13, 2005
Last updated: June 15, 2010
Last verified: June 2010
History of Changes
  Purpose

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
Chemotherapy
 Drug: FOLFIRI
Drug: FOLFOX-4
Drug: FOLFIRI-HD
Drug: FOLFOX-7
Drug: FOLFIRINOX
 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:

U.S. FDA Resources

Further study details as provided by Centre Val d'Aurelle - Paul Lamarque:

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
 Drug: FOLFIRI
FOLFIRI : Irinotecan : 180 mg/m² 90 min continuous perfusion during levorin d1 every 2 weeks
Active Comparator: B
FOLFOX-4
 Drug: FOLFOX-4
FOLFOX 4 : Oxaliplatine : 85 mg/m² 2h continuous perfusion during levorin d1 every 2weeks
Experimental: C
FOLFIRI-HD
 Drug: FOLFIRI-HD
High Dose FOLFIRI : Irinotecan : 260 mg/m² in 90min continuous perfusion during levorin d1 every 2 weeks
Experimental: D
FOLFOX-7
 Drug: FOLFOX-7
FOLFOX 7 : Oxaliplatine : 130 mg/m² in 2h continuous perfusion during levorin d1 every 2 weeks
Experimental: E
FOLFIRINOX
 Drug: FOLFIRINOX
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

-

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

Locations
France
CRLC Val d'Aurelle
Montpellier, France, 34298
Sponsors and Collaborators
Centre Val d'Aurelle - Paul Lamarque
Pfizer
Sanofi
Chugai Pharmaceutical
Investigators
Principal Investigator: Marc YCHOU, MD, PhD CRLC Val d'Aurelle
Study Chair: Michel RIVOIRE, MD CRLC Leon Berard - Lyon
  More Information

No publications provided

ClinicalTrials.gov 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
Neoplasms, Second Primary
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases

ClinicalTrials.gov processed this record on May 23, 2013