Spots Global Cancer Trial Database for QoL in mCRC Elderly Patients Receiving First-line Therapy Based on Simplified Geriatric Parameters.

Study Description

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

Detailed 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

Keywords

Eligibility

Minimum Age: 75 Years

Eligible Ages: OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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