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Brief Title: Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan1 Levels
Official Title: Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan-1 Levels
Study ID: NCT03117972
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Christophe BORG, Pr
Affiliation: Centre Hospitalier Universitaire de Besançon
Role: PRINCIPAL_INVESTIGATOR