Intensified Chemotherapy in CRC After Resection of Liver Metastases
NCT ID: NCT00208260
Last Updated: 2010-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
124 participants
INTERVENTIONAL
2004-04-30
2007-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
FOLFIRI
FOLFIRI
FOLFIRI : Irinotecan : 180 mg/m² 90 min continuous perfusion during levorin d1 every 2 weeks
B
FOLFOX-4
FOLFOX-4
FOLFOX 4 : Oxaliplatine : 85 mg/m² 2h continuous perfusion during levorin d1 every 2weeks
C
FOLFIRI-HD
FOLFIRI-HD
High Dose FOLFIRI : Irinotecan : 260 mg/m² in 90min continuous perfusion during levorin d1 every 2 weeks
D
FOLFOX-7
FOLFOX-7
FOLFOX 7 : Oxaliplatine : 130 mg/m² in 2h continuous perfusion during levorin d1 every 2 weeks
E
FOLFIRINOX
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
Interventions
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FOLFIRI
FOLFIRI : Irinotecan : 180 mg/m² 90 min continuous perfusion during levorin d1 every 2 weeks
FOLFOX-4
FOLFOX 4 : Oxaliplatine : 85 mg/m² 2h continuous perfusion during levorin d1 every 2weeks
FOLFIRI-HD
High Dose FOLFIRI : Irinotecan : 260 mg/m² in 90min continuous perfusion during levorin d1 every 2 weeks
FOLFOX-7
FOLFOX 7 : Oxaliplatine : 130 mg/m² in 2h continuous perfusion during levorin d1 every 2 weeks
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 Criteria
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Inclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Sanofi
INDUSTRY
Chugai Pharmaceutical
INDUSTRY
Institut du Cancer de Montpellier - Val d'Aurelle
OTHER
Principal Investigators
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Marc YCHOU, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CRLC Val d'Aurelle
Michel RIVOIRE, MD
Role: STUDY_CHAIR
CRLC Leon Berard - Lyon
Locations
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CRLC Val d'Aurelle
Montpellier, , France
Countries
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Other Identifiers
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METHEP/2004/22
Identifier Type: -
Identifier Source: org_study_id
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