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Spots Global Cancer Trial Database for Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan1 Levels

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Christophe BORG, Pr

Affiliation: Centre Hospitalier Universitaire de Besançon

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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