Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Elderly Patients
  • Metastatic Colorectal Cancer
  • Quality of Life
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Other

Participation Requirements

Age
Between 75 years and 125 years
Gender
Both males and females

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 ...

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

Tracking Information

NCT #
NCT03828227
Collaborators
Not Provided
Investigators
Not Provided