Back to resultsIntensified Chemotherapy in CRC After Resection of Liver Metastases
Primary Purpose
Colorectal Cancer, Liver Metastases, Chemotherapy
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
FOLFIRI
FOLFOX-4
FOLFIRI-HD
FOLFOX-7
FOLFIRINOX
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
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: -
Sites / Locations
- CRLC Val d'Aurelle
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Experimental
Experimental
Experimental
Arm Label
A
B
C
D
E
Arm Description
FOLFIRI
FOLFOX-4
FOLFIRI-HD
FOLFOX-7
FOLFIRINOX
Outcomes
Primary Outcome Measures
Response
Secondary Outcome Measures
Safety
Survival
Secondary resection
Full Information
NCT ID
NCT00208260
First Posted
September 13, 2005
Last Updated
June 15, 2010
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Collaborators
Pfizer, Sanofi, Chugai Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00208260
Brief Title
Intensified Chemotherapy in CRC After Resection of Liver Metastases
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Collaborators
Pfizer, Sanofi, Chugai Pharmaceutical
4. Oversight
5. Study Description
Brief Summary
Randomized, open label, multicentre phase II trial followed by phase III comparing overall survival after having selected the best experimental arm.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Liver Metastases, Chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
FOLFIRI
Arm Title
B
Arm Type
Active Comparator
Arm Description
FOLFOX-4
Arm Title
C
Arm Type
Experimental
Arm Description
FOLFIRI-HD
Arm Title
D
Arm Type
Experimental
Arm Description
FOLFOX-7
Arm Title
E
Arm Type
Experimental
Arm Description
FOLFIRINOX
Intervention Type
Drug
Intervention Name(s)
FOLFIRI
Intervention Description
FOLFIRI : Irinotecan : 180 mg/m² 90 min continuous perfusion during levorin d1 every 2 weeks
Intervention Type
Drug
Intervention Name(s)
FOLFOX-4
Intervention Description
FOLFOX 4 : Oxaliplatine : 85 mg/m² 2h continuous perfusion during levorin d1 every 2weeks
Intervention Type
Drug
Intervention Name(s)
FOLFIRI-HD
Intervention Description
High Dose FOLFIRI : Irinotecan : 260 mg/m² in 90min continuous perfusion during levorin d1 every 2 weeks
Intervention Type
Drug
Intervention Name(s)
FOLFOX-7
Intervention Description
FOLFOX 7 : Oxaliplatine : 130 mg/m² in 2h continuous perfusion during levorin d1 every 2 weeks
Intervention Type
Drug
Intervention Name(s)
FOLFIRINOX
Intervention Description
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
Primary Outcome Measure Information:
Title
Response
Time Frame
end of chemotherapy
Secondary Outcome Measure Information:
Title
Safety
Time Frame
during study treatment
Title
Survival
Time Frame
2 years
Title
Secondary resection
Time Frame
surgery after chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc YCHOU, MD, PhD
Organizational Affiliation
CRLC Val d'Aurelle
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michel RIVOIRE, MD
Organizational Affiliation
CRLC Leon Berard - Lyon
Official's Role
Study Chair
Facility Information:
Facility Name
CRLC Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
12. IPD Sharing Statement
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Intensified Chemotherapy in CRC After Resection of Liver Metastases
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