A national, multicenter, open-label, randomized phase III study. The trial aim is to determine the best therapeutic strategies according with the HRQoL.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
49
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
* 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).
CH Abbeville
Abbeville, France
CHU Amiens Hôpital sud
Amiens, France
Health-related quality of life (HRQoL) at 6 months in the "candidate group".
Improvement of HRQoL at 6 months by 10 points compared to the score at inclusion on the following targeted dimensions: emotional functioning (4 items) and global health (2 items) (score from 6-30 with higher values representing better quality of life).
Time frame: At 6 months
Number of patients amenable to second-line therapy.
Proportion of patients amenable to second-line therapy.
Time frame: until 58 months
Number of patient amenable to surgery and/or locoregional therapy.
Proportion of patients amenable to salvage surgery and/or locoregional therapy (e.g., radiofrequency ablation, stereotactic radiotherapy, …).
Time frame: until 58 months
Progression-free survival (PFS)
PFS is defined as time from date of first dose of study treatment to date of first documented PD or death due to any cause determined by the Investigator assessment in accordance to RECIST 1.1. Alive patients without progression will be censored at the last tumor assessment, either during study treatment period or during follow-up period.
Time frame: until 58 months
Overall survival (OS)
OS defined as the time between the date of the first dose of study treatment and the death date. Alive patients will be censored at the last date known to be alive, either during study treatment period or during follow-up period.
Time frame: Until 58 months
Other dimensions of health-related quality of life (HRQoL) and longitudinal HRQoL
HRQoL: all other dimensions of the QLQC-30 and QLQELD-14 questionnaires, and longitudinal analyses of the QLQC-30 and QLQELD-14 elderly specific module integrating all measurement times.
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Clinique de l'Europe
Amiens, France
CH Beauvais
Beauvais, France
Hôpital Duchenne
Boulogne-sur-Mer, France
Centre hospitalier de Cannes
Cannes, France
CH Compiègne Noyon
Compiègne, France
UCOG Picardie Groupe Hospitalier
Creil, France
CHU Henri Mondor
Créteil, France
Centre geroges François Leclerc
Dijon, France
...and 12 more locations
Time frame: Until 58 months
Determination of instrumental activities of daily living (IADL) as prognostic factor for overall survival (OS).
IADL as prognostic factor for overall survival (OS) and treatment toxicity.
Time frame: Until 58 months
G8 score at baseline.
To determine G8 score at baseline and to correlate the candidate group and the non-candidate group according to G8 score.
Time frame: until 58 months
Performance status geriatric (PSG) score.
External analysis of PSG score as predictive for treatment efficacy: PFS and OS.
Time frame: until 58 months