Intensified Chemotherapy in CRC After Resection of Liver Metastases

NCT ID: NCT00208260

Last Updated: 2010-06-16

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2007-08-31

Brief Summary

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Randomized, open label, multicentre phase II trial followed by phase III comparing overall survival after having selected the best experimental arm.

Detailed Description

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Conditions

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Colorectal Cancer Liver Metastases Chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

FOLFIRI

Group Type ACTIVE_COMPARATOR

FOLFIRI

Intervention Type DRUG

FOLFIRI : Irinotecan : 180 mg/m² 90 min continuous perfusion during levorin d1 every 2 weeks

B

FOLFOX-4

Group Type ACTIVE_COMPARATOR

FOLFOX-4

Intervention Type DRUG

FOLFOX 4 : Oxaliplatine : 85 mg/m² 2h continuous perfusion during levorin d1 every 2weeks

C

FOLFIRI-HD

Group Type EXPERIMENTAL

FOLFIRI-HD

Intervention Type DRUG

High Dose FOLFIRI : Irinotecan : 260 mg/m² in 90min continuous perfusion during levorin d1 every 2 weeks

D

FOLFOX-7

Group Type EXPERIMENTAL

FOLFOX-7

Intervention Type DRUG

FOLFOX 7 : Oxaliplatine : 130 mg/m² in 2h continuous perfusion during levorin d1 every 2 weeks

E

FOLFIRINOX

Group Type EXPERIMENTAL

FOLFIRINOX

Intervention Type DRUG

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

Intervention Type DRUG

FOLFOX-4

FOLFOX 4 : Oxaliplatine : 85 mg/m² 2h continuous perfusion during levorin d1 every 2weeks

Intervention Type DRUG

FOLFIRI-HD

High Dose FOLFIRI : Irinotecan : 260 mg/m² in 90min continuous perfusion during levorin d1 every 2 weeks

Intervention Type DRUG

FOLFOX-7

FOLFOX 7 : Oxaliplatine : 130 mg/m² in 2h continuous perfusion during levorin d1 every 2 weeks

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role collaborator

Chugai Pharmaceutical

INDUSTRY

Sponsor Role collaborator

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role lead

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

Site Status

Countries

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France

Other Identifiers

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METHEP/2004/22

Identifier Type: -

Identifier Source: org_study_id

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