The main objective is to evaluate progression-free survival (PFS) at 4 months. The secondary objectives are to evaluate the objective response rate (OR) (= complete responses (CR) and partial responses (PR)) according to the RECIST v1.1 criteria, the progression-free survival (PFS), the overall survival (OS), the overall survival from the date of the first-line chemotherapy used on the metastatic disease, the treatment tolerance (NCI CTC AE V4 criteria, except for peripheral neurological toxicity (Lévi Scale)), the quality of life according to the EORTC QLQ-C30 criteria. The objectives of the biological study are to evaluate potentially predictive anti-EGFR and anti-VEGF response factors and CEC rates as predictive biomarkers for the efficacy of bevacizumab associated with chemotherapy in mCRC treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
133
85mg/m² over 120 mn on D1 every 2 weeks up to progression or toxicity
400 mg/m² (racemic) (or 200 mg/m² if L-folinic acid) over 2 h IV on D1 (in the same time that oxaliplatin or irinotecan) every 2 weeks up to progression or toxicity
400mg/m² in bolus on D1, then 2400mg/m² over 46 h every 2 weeks up to progression or toxicity
180 mg/m2 over 90 mn IV on D1 every 2 weeks up to progression or toxicity
5 mg/kg IV over 90 mn on D1 every 2 weeks up to progression or toxicity
500mg/m² on D1 every 2 weeks up to progression or toxicity
Centre rené Gauducheau
Saint-Herblain, France
Progression-free survival (PFS) at 4 months
Progression-free survival is defined as the time from randomization to progression (RECIST v1.1 criteria) or death. Patients alive without progression will be censored at the last follow-up.
Time frame: 4 months
Objective response rate (OR)
The objective response rate is defined as the occurence of a complete response \[CR\] or a partial responses \[PR\] according to RECIST V1.1 between date of randomization and date of end of treatment. It will be evaluated by the investigator with RECIST v1.1 criteria every 6 weeks up to disease progression.
Time frame: 12 months
Progression-free survival (PFS)
Progression-free survival is defined as the time from randomization to progression (RECIST v1.1 criteria) or death. Patients alive without progression will be censored at the last follow-up.
Time frame: 4 months
Overall survival (OS)
Overall survival is defined as the time from randomization to death any cause or last follow-up (censored data).
Time frame: until death or progression (24 months)
Overall survival from the date of the first-line chemotherapy used on the metastatic disease
Overall survival from the date of the first-line chemotherapy used on the metastatic disease is defined as the time from the first day of the first-line chemotherapy used on the metastatic disease to death any cause or last follow-up news (censored data).
Time frame: until death or progression (24 months)
Treatment tolerance
Tolerance of the treatment will be based on toxicities of evaluated products by clinical and biological measurements (NCIC/CTC (CTCAE V4) criteria, except for peripheral neuropathy toxicity (Lévi scale)).
Time frame: Every 2 weeks, during the treatment.
Quality of life
Quality of life will be evaluated with the EORTC QLQ - C30.
Time frame: every 6 weeks
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