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Intensified Chemotherapy in CRC After Resection of Liver Metastases

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00208260
First Posted: September 21, 2005
Last Update Posted: June 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Pfizer
Sanofi
Chugai Pharmaceutical
Information provided by:
Institut du Cancer de Montpellier - Val d'Aurelle
  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
Intervention Model: Parallel Assignment
Masking: None (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.

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

Primary Outcome Measures:
  • Response [ Time Frame: end of chemotherapy ]

Secondary Outcome Measures:
  • Safety [ Time Frame: during study treatment ]
  • Survival [ Time Frame: 2 years ]
  • Secondary resection [ Time Frame: surgery after chemotherapy ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00208260


Locations
France
CRLC Val d'Aurelle
Montpellier, France, 34298
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
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

ClinicalTrials.gov Identifier: NCT00208260     History of Changes
Other Study ID Numbers: METHEP/2004/22
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: June 16, 2010
Last Verified: June 2010

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
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
Fluorouracil
Oxaliplatin
Leucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins