Intensified Chemotherapy in CRC After Resection of Liver Metastases

Colorectal Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00208260
• Other study ID #: METHEP/2004/22
• 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
• 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

Related Conditions & MeSH terms

• Chemotherapy
• Colorectal Cancer
• Colorectal Neoplasms
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

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