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

NCT03828227 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-07-18

No results posted yet for this study

Summary

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

Conditions

Interventions

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).

Sponsors & Collaborators

  • GERCOR - Multidisciplinary Oncology Cooperative Group

    lead OTHER

Principal Investigators

  • Elisabeth CAROLA, MD · UCOG Picardie Groupe Hospitalier Public du Sud de l'Oise (GHPSO)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-14
Primary Completion
2023-11-10
Completion
2025-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03828227 on ClinicalTrials.gov