Quality of Life in Elderly Patients With Metastatic Colorectal Cancer Receiving First-line Therapy Based on Simplified Geriatric Parameters
Last updated on July 2021Recruitment
- 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