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FOLFOXIRI + bevacizumab, 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 or bevacizumab-capecitabine) until disease progression or limiting toxicities

FOLFOX or FOLFIRI + bevacizumab 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 ou bevacizumab capecitabine) until disease progression or limiting toxicities

FOLFOXIRI

FOLFOX

FOLFIRI

LV5FU2

Christophe BORG, Pr

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.

Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan1 Levels

Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan-1 Levels

Delay from the date of randomization to the disease progression (RECIST) or death from any cause whichever occurs first

Centre Hospitalier Universitaire de Besancon

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan1 Levels	NCT03117972	Metastatic Colo...	FOLFOXIRI FOLFOX FOLFIRI Bevacizumab LV5FU2 Capecitabine	18 Years - 76 Years	Centre Hospitalier Universitaire de Besancon
Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan1 Levels	NCT03117972	Metastatic Colo...	FOLFOXIRI FOLFOX FOLFIRI Bevacizumab LV5FU2 Capecitabine	18 Years - 76 Years	Centre Hospitalier Universitaire de Besancon

Spots Global Cancer Trial Database for chemotherapy intensification