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

Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Study ID
NCT03828227
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Elderly Patients
  • Metastatic Colorectal Cancer
  • Quality of Life

Eligibility Criteria

Sex
ALL
Age
75 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OPTIMOX-bevacizumab — DRUG
    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
  • Capecitabine plus bevacizumab — DRUG
    * 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).

Study Details

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

Key Dates

First listed
Feb 4, 2019
Start date
Jun 14, 2019
Status verified
Jul 2025
Primary completion
Nov 10, 2023
Completion
Dec 31, 2025

Study Design

Enrollment
49 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: "Candidate group" OPTIMOX plus bevacizumab (Arm A)
    Patients with : * Serum albumin level ≥ 30g/L, * ECOG PS 0-1 (whatever mini GDS score) or ECOG PS 2 with mini GDS 0 (ie, no depression). Adapted FOLFOX7 (aFOLFOX7)-bevacizumab for 6 cycles and then Adapted LV5FU2 (aLV5FU2)-bevacizumab (until progression or or unacceptable limiting toxicity)
  • Active Comparator: "Candidate group" - Capecitabine-bevacizumab (Arm B)
    Patients with : * Serum albumin level ≥ 30g/L, * ECOG PS 0-1 (whatever mini GDS score) or ECOG PS 2 with mini GDS 0 (ie, no depression). This treatment regimen will be given until disease progression (PD) or unacceptable limiting toxicity, as follows:
  • Active Comparator: "Non candidate group" - Capecitabine-bevacizumab
    Patients with: * Serum albumin level \< 30g/L. * And/ or ECOG PS 2 and mini GDS ≥ 1 (ie, depression). This treatment regimen will be given until disease progression (PD) or unacceptable limiting toxicity, as follows:

Primary Outcome Measure

Health-related quality of life (HRQoL) at 6 months in the "candidate group". [ Time Frame: At 6 months ]

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