In first-line metastatic colorectal cancer (mCRC), baseline prognostic factors allowing death risk and strategy stratification are lacking. In this setting, a simple biological scoring system have recently been proposed, including LDH and CD138 binary status seric values, identifying one third of patients with worst prognostic. Intensified-chemotherapy strategies, combining 5-fluorouracile, Oxaliplatin, Irinotecan and Bevacizumab, are beneficial for patients having a bad prognostic, defined by the BRAFV600E mutation, concerning 5-8% of first line mCRC. For the 30% of patients with LDH-CD138 elevated score, the purpose of CLavSyn phase II study is to compare the PFS of one intensified arm (FOLFOXIRI Bevacizumab) to one standard chemotherapy arm, in order to better discriminate treatment strategies, at metastatic diagnosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
12 cycles
12 cycles
12 cycles
12 cycles
Maintenance chemotherapy
Maintenance chemotherapy
Centre Hospitalier Universitaire de Besançon
Besançon, France
Centre Hospitalier de Boulogne sur Mer
Boulogne-sur-Mer, France
CH de Colmar
Colmar, France
Institut de Cancérologie de Bourgogne
Dijon, France
CHRU de LILLE
Lille, France
Hôpital Nord Franche-Comté
Montbéliard, France
CHU de REIMS, Hôpital Robert Debré
Reims, France
Clinique Sainte Anne
Strasbourg, France
Centre Paul Strauss
Strasbourg, France
CHU de Tours
Tours, France
Progression Free Survival
Delay from the date of randomization to the disease progression (RECIST) or death from any cause whichever occurs first
Time frame: up to 4 years (3 years of inclusion and 12 months of follow up after the last patient included)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.