Last updated on July 2019

Quality of Life in Elderly Patients With Metastatic Colorectal Cancer Receiving First-line Therapy Based on Simplified Geriatric Parameters

Brief description of study

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

Detailed Study 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

Clinical Study Identifier: NCT03828227

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