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.

Status Active, not recruiting

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 ;

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Elderly Patients
• Metastatic Colorectal Cancer
• Quality of Life

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