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Trial record 1 of 1 for:    NCT00208260
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Intensified Chemotherapy in CRC After Resection of Liver Metastases

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.
 
ClinicalTrials.gov Identifier: NCT00208260
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 16, 2010
Sponsor:
Collaborators:
Pfizer
Sanofi
Chugai Pharmaceutical
Information provided by:
Institut du Cancer de Montpellier - Val d'Aurelle

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 21, 2005
Last Update Posted Date June 16, 2010
Study Start Date  ICMJE April 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2007)
Response [ Time Frame: end of chemotherapy ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Response
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2007)
  • Safety [ Time Frame: during study treatment ]
  • Survival [ Time Frame: 2 years ]
  • Secondary resection [ Time Frame: surgery after chemotherapy ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Safety
  • Survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intensified Chemotherapy in CRC After Resection of Liver Metastases
Official Title  ICMJE 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.
Brief Summary Randomized, open label, multicentre phase II trial followed by phase III comparing overall survival after having selected the best experimental arm.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Liver Metastases
  • Chemotherapy
Intervention  ICMJE
  • Drug: FOLFIRI
    FOLFIRI : Irinotecan : 180 mg/m² 90 min continuous perfusion during levorin d1 every 2 weeks
  • Drug: FOLFOX-4
    FOLFOX 4 : Oxaliplatine : 85 mg/m² 2h continuous perfusion during levorin d1 every 2weeks
  • Drug: FOLFIRI-HD
    High Dose FOLFIRI : Irinotecan : 260 mg/m² in 90min continuous perfusion during levorin d1 every 2 weeks
  • Drug: FOLFOX-7
    FOLFOX 7 : Oxaliplatine : 130 mg/m² in 2h continuous perfusion during levorin d1 every 2 weeks
  • 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
Study Arms  ICMJE
  • Active Comparator: A
    FOLFIRI
    Intervention: Drug: FOLFIRI
  • Active Comparator: B
    FOLFOX-4
    Intervention: Drug: FOLFOX-4
  • Experimental: C
    FOLFIRI-HD
    Intervention: Drug: FOLFIRI-HD
  • Experimental: D
    FOLFOX-7
    Intervention: Drug: FOLFOX-7
  • Experimental: E
    FOLFIRINOX
    Intervention: Drug: FOLFIRINOX
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2007)
124
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
300
Actual Study Completion Date  ICMJE August 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00208260
Other Study ID Numbers  ICMJE METHEP/2004/22
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Institut du Cancer de Montpellier - Val d'Aurelle
Collaborators  ICMJE
  • Pfizer
  • Sanofi
  • Chugai Pharmaceutical
Investigators  ICMJE
Principal Investigator: Marc YCHOU, MD, PhD CRLC Val d'Aurelle
Study Chair: Michel RIVOIRE, MD CRLC Leon Berard - Lyon
PRS Account Institut du Cancer de Montpellier - Val d'Aurelle
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP