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QoL in mCRC Elderly Patients Receiving First-line Therapy Based on Simplified Geriatric Parameters. — COLAGE  

Quality of Life Clinical Trial

Official title:
Phase III Study to Evaluate the Quality of Life in Elderly Patients With Metastatic Colorectal Cancer Receiving First-line Therapy Based on Simplified Geriatric Parameters.

Clinical Trial Summary

A national, multicenter, open-label, randomized phase III study. The trial aim is to determine the best therapeutic strategies according with the HRQoL.

Clinical Trial Description

Treatment cohort will be determined based on three parameters: - Serum albumin level at baseline, - ECOG Performance Status, - Mini GDS. The "Candidate" group will be defined according to (all the following criteria must be fulfilled): - Serum albumin level ≥ 30g/L, - ECOG PS 0-1 (whatever mini GDS score) or ECOG PS 2 with mini GDS 0 (ie, no depression). The "Non-candidate" cohort group will be defined according to (at least one of those parameters is fulfilled): - Serum albumin level < 30g/L. - And/ or ECOG PS 2 and mini GDS ≥ 1 (ie, depression). Patients in the "Candidate group" will be randomized to: - OPTIMOX bevacizumab (arm A), - Capecitabine + bevacizumab (arm B), in priority followed by FOLFOX-bevacizumab at first progression. Patients in the "Non-candidate" group cohort - Not randomized, follow-up patients receiving: capecitabine + bevacizumab ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03828227
Study type Interventional
Source GERCOR - Multidisciplinary Oncology Cooperative Group
Contact
Status Active, not recruiting
Phase Phase 3
Start date June 14, 2019
Completion date September 30, 2024
View Details
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