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Clinical Trial Summary

In patients in progression after oxaliplatin and irinotecan, the study FOLFIRINOX 3 proposes to evaluate the interest of modifying the standard pattern of administration of the molecule of irinotecan in order to make it more efficient. In combination with other chemotherapy drugs (5-fluorouracil, oxaliplatin, folinic acid and bevacizumab), irinotecan will be administered at the beginning and end of each cycle of chemotherapy, whereas it is normally administered at one time in the regimen. standard of treatment.

The hypothesis of this study is an increase in the objective response rate at 2 months of 10 to 30% with a scheme by FOLFIRINOX3 - bevacizumab compared to an optimal treatment to date by FOLFIRINOX-bevacizumab.

Clinical Trial Description

Primary objective

- Main objective of phase I: To evaluate the acute toxicity of treatment with FOLFIRINOX 3 - bevacizumab

- Main objective of phase II: To evaluate the efficacy of treatment with FOLFIRINOX 3 - bevacizumab in terms of objective response according to the RECIST criteria.

Secondary objectives

- To evaluate the efficacy of treatment with FOLFIRINOX 3 - bevacizumab in terms of objective response according to the criteria of CHOI, progression-free survival (PFS) and overall survival (OS)

- To evaluate the late toxicity of treatment with FOLFIRINOX 3 - bevacizumab

- Evaluate the quality of life ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03795311
Study type Interventional
Source Centre Georges Francois Leclerc
Contact François Ghiringhelli, PU PH
Phone 03 80 73 77 53
Status Recruiting
Phase Phase 1/Phase 2
Start date November 7, 2018
Completion date January 7, 2023

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