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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

June 14, 2019

Primary Completion Date

November 10, 2023

Study Completion Date

December 31, 2025

Conditions
Elderly PatientsMetastatic Colorectal CancerQuality of Life
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)."

Trial Locations (22)

Unknown

CH Abbeville, Abbeville

CHU Amiens Hôpital sud, Amiens

Clinique de l'Europe, Amiens

CH Beauvais, Beauvais

Hôpital Duchenne, Boulogne-sur-Mer

Centre hospitalier de Cannes, Cannes

CH Compiègne Noyon, Compiègne

UCOG Picardie Groupe Hospitalier, Creil

CHU Henri Mondor, Créteil

Centre geroges François Leclerc, Dijon

Institut Daniel Hollard, Grenoble

Institut Hospitalier Franco-Britannique, Levallois-Perret

Hôpital Privé Jean Mermoz, Lyon

Institut Paoli-Calmettes, Marseille

CH Sud Ile de France, Melun

CH Mont de Marsan, Mont-de-Marsan

Centre Antoine Lacassagne, Nice

Hôpital des Diaconnesses Croix Saint Simon, Paris

Hôpital Saint Antoine, Paris

Institut Mutualiste Montsouris, Paris

CH Annecy Genevois, Pringy

CH Saint Malo, St-Malo

All Listed Sponsors
lead

GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER

NCT03828227 - QoL in mCRC Elderly Patients Receiving First-line Therapy Based on Simplified Geriatric Parameters. | Biotech Hunter | Biotech Hunter