NCT03828227

QoL in mCRC Elderly Patients Receiving First-line Therapy Based on Simplified Geriatric Parameters.

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Elderly Patients
• Metastatic Colorectal Cancer
• Quality of Life

Interventions

Type	Name	Description
DRUG	OPTIMOX-bevacizumab	Induction Adapted FOLFOX7 (aFOLFOX7)-bevacizumab for 6 cycles (3 months) * Bevacizumab: 5 mg/kg IV (day 1, every 2 weeks \[q2w\]), * Folinic acid (FA): 400 mg/m² IV/2h (day 1, q2w), * Oxaliplatin: 85 mg/m² IV/2h (day 1, q2w), * 5-fluorouracil (5-FU) continuous infusion 2400 mg/m² IV/46h (day 1-2, q2w), * No 5-FU bolus. then Maintenance Adapted LV5FU2 (aLV5FU2)-bevacizumab (until progression or or unacceptable limiting toxicity) * Bevacizumab: 5 mg/kg IV (day 1, q2w), * FA: 400 mg/m² IV/2h (day 1, q2w), * 5-FU continuous infusion 2400 mg/m² IV/46h (day 1-2, q2w) * No 5-FU bolus
DRUG	Capecitabine plus bevacizumab	* Bevacizumab: 7.5 mg/kg intravenous infusion \[IV\] (day 1; q3w), * Capecitabine: 1000 mg/m² orally twice a day (day 1 through day 14, q3w).

Timeline

• Start date: 2019-06-14
• Primary completion: 2023-11-10
• Completion: 2025-12-01
• First posted: 2019-02-04
• Last updated: 2025-07-18

Locations

22 sites across 1 country: France