Intensified Chemotherapy in CRC After Resection of Liver Metastases

Institut du Cancer de Montpellier - Val d'Aurelle

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chemotherapy; Liver Metastases; Colorectal Cancer

Treatments: Drug: FOLFIRI; Drug: FOLFOX-4; Drug: FOLFOX-7; Drug: FOLFIRI-HD; Drug: FOLFIRINOX

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00208260

METHEP/2004/22

Details and patient eligibility

About

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

Enrollment: 124 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

-

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 5 patient groups

A

Active Comparator group

Description:

FOLFIRI

Treatment:

Drug: FOLFIRI

B

Active Comparator group

Description:

FOLFOX-4

Treatment:

Drug: FOLFOX-4

C

Experimental group

Description:

FOLFIRI-HD

Treatment:

Drug: FOLFIRI-HD

D

Experimental group

Description:

FOLFOX-7

Treatment:

Drug: FOLFOX-7

E

Experimental group

Description:

FOLFIRINOX

Treatment:

Drug: FOLFIRINOX