NCT03117972

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	FOLFOXIRI	12 cycles
DRUG	FOLFOX	12 cycles
DRUG	FOLFIRI	12 cycles
DRUG	Bevacizumab	12 cycles
DRUG	LV5FU2	Maintenance chemotherapy
DRUG	Capecitabine	Maintenance chemotherapy

Timeline

• Start date: 2017-08-04
• Primary completion: 2024-08-07
• Completion: 2024-11-18
• First posted: 2017-04-18
• Last updated: 2025-02-05

Locations

10 sites across 1 country: France