BEvacizumab plus Trifluridine/tipiracil in a bi-WEEkly administration to reduce grade 3-4 Neutropenia in patients with mCRC: A prospective, multicenter, comparative, randomized GERCOR G-124 BETWEEN phase II study

Condition studied

colorectal adenocarcinoma

Investigational medicinal product(s)

Eligibility

Primary endpoint

The occurrence of grade 3-4 neutropenia in patients undergoing treatment with the combination of bevacizumab and bi-weekly administration of trifluridine/tipiracil (experimental arm) compared to a conventional administration (control arm).

Endpoint detail

OS in both arms,, PFS in both arms,, BOR in both arms,, DCR in both arms,, OS, PFS, BOR, and DCR in subgroups of patients with at least one episode of grade 3-4 neutropenia or without grade 3-4 neutropenia in both arms,, Incidence and grade of AEs and SAEs in both arms,, Incidence of dose delay, dose reduction, and dose reduction not related to grade 3-4 neutropenia in both arms,, Treatment compliance (Percentage of patients with compliance to treatment) in both arms,, Time to ECOG PS deterioration.