Neoplasms

Digestive System Diseases

All Conditions

Behaviors and Mental Disorders

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

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Intestinal Diseases

Rectal Diseases

Quality of Life

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

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Capecitabine

Bevacizumab

Leucovorin

Fluorouracil

Levoleucovorin

Oxaliplatin

Folic Acid

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Folinic Acid

Folate

Vitamin B9

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)

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:

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:

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

OPTIMOX-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).

Capecitabine plus bevacizumab

Elisabeth CAROLA, MD

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

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.

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).

Proportion of patients amenable to second-line therapy.

Proportion of patients amenable to salvage surgery and/or locoregional therapy (e.g., radiofrequency ablation, stereotactic radiotherapy, ...).

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.

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.

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.

IADL as prognostic factor for overall survival (OS) and treatment toxicity.

To determine G8 score at baseline and to correlate the candidate group and the non-candidate group according to G8 score.

External analysis of PSG score as predictive for treatment efficacy: PFS and OS.

Spots Global Cancer Trial Database for capecitabine plus bevacizumab