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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00208260
Other study ID # METHEP/2004/22
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received September 13, 2005
Last updated June 15, 2010
Start date April 2004
Est. completion date August 2007

Study information

Verified date June 2010
Source Institut du Cancer de Montpellier - Val d'Aurelle
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
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

Locations

Country Name City State
France CRLC Val d'Aurelle Montpellier

Sponsors (4)

Lead Sponsor Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle Chugai Pharmaceutical, Pfizer, Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response end of chemotherapy No
Secondary Safety during study treatment Yes
Secondary Survival 2 years No
Secondary Secondary resection surgery after chemotherapy No
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