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FOLFOX6 + bevacizumab (D1=D15, 12 cycles)

Raltitrexed + Oxaliplatin + Bevacizumab (D1=D21, 8 cycles)

Bevacizumab 5 mg/kg administered as an iv infusion for 1h30, then for 1h and for 30 min. at the following cycles, respectively.

Oxaliplatin 85 mg/m² administered as an iv infusion for 2h Elvorine 200 mg/m² administered as an iv infusion for 2h 5FU 400 mg/m2 bolus then 5FU 2,400 mg/m² iv infusion for 46h D1=D15 (12 cycles)

bevacizumab, oxaliplatin and 5FU combination

Bevacizumab 7.5 mg/kg administered as an iv infusion for 1h30, then administered for 1h and 30 min at the following cycles, respectively.

Oxaliplatin 130 mg/m² administered as an iv infusion for 2h Raltitrexed 3 mg/m² administered as an iv infusion for 15 min

Bevacizumab, oxaliplatin and raltitrexed combination

Emmanuelle Samalin-Scalzi, MD

This phase 2 trial aims to evaluate the continued use of bevacizumab with raltitrexed and oxaliplatin combination versus FOLFOX6 plus bevacizumab in patients with metastatic colorectal cancer whose disease has progressed after irinotecan-based chemotherapy.

Eligible patients are randomly allocated to receive either bevacizumab with raltitrexed and oxaliplatin combination or bevacizumab with FOLFOX 6 combination. Random allocation schedule is performed using a minimization technique for the following stratification factors:

* Center
* Number of metastatic sites: 1 versus \> 1
* Bevacizumab-based first-line therapy: Yes versus No

2nd-line Treatment of Metastatic Colorectal Cancer

A Multicenter Randomized Phase 2 Trial to Evaluate the Triplet Combination of Raltitrexed, Oxaliplatin and Bevacizumab Versus FOLFOX6 Plus Bevacizumab in Second-line Treatment of Metastatic Colorectal Cancer

DFS is estimated from the date of randomization until the first date of objectively documented event or death

Treatment-related toxicity is evaluated according to the NCI-CTCAE v.4 criteria.

Objective response rate is evaluated according to the RECIST V 1.1 criteria.

OS is estimated from the date of randomization until the date of death from any cause

The cost-effectiveness study includes the number of hospital stays (treatment and toxicity), the global cost of treatments, and the cost of hospital stays due to treatment-induced toxicity

Quality of life is measured using the QLQ-C30 questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
2nd-line Treatment of Metastatic Colorectal Cancer	NCT01532804	Metastatic Colo...	bevacizumab, ox... Bevacizumab, ox...	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle
2nd-line Treatment of Metastatic Colorectal Cancer	NCT01532804	Metastatic Colo...	bevacizumab, ox... Bevacizumab, ox...	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle
2nd-line Treatment of Metastatic Colorectal Cancer	NCT01532804	Metastatic Colo...	bevacizumab, ox... Bevacizumab, ox...	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle
2nd-line Treatment of Metastatic Colorectal Cancer	NCT01532804	Metastatic Colo...	bevacizumab, ox... Bevacizumab, ox...	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle

Spots Global Cancer Trial Database for bevacizumab, oxaliplatin and raltitrexed combination