colorectal adenocarcinoma
Conditions
Brief summary
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).
Detailed description
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.
Interventions
Sponsors
Association Gercor
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
France
Outcome results
None listed