NCT00471965

Oxaliplatin + 5-FluoroUracil/LeucoVorin (5-FU/LV) (FOLFOX4) Versus Doxorubicin as Palliative Chemotherapy in Advanced Hepatocellular Carcinoma Patients

Oxaliplatin(Eloxatin®) + 5-FU/LV (FOLFOX4) Compared With Single Agent Doxorubicin (Adriamycin®) as Palliative Chemotherapy in Advanced Hepatocellular Carcinoma Patients Ineligible for Curative Resection or Local Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 371 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Primary: * Overall Survival (OS) Secondary: * Time to Tumor Progression (TTP) * Response Rate (RR) * Improvement of Quality of Life (QoL) * Safety * Secondary resection rate

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	Oxaliplatin + 5-Fluorouracil/Leucovorin	Day 1: Oxaliplatin 85mg/m² 2h IV infusion, leucovorin 200mg/m² 2h IV infusion, 5-fluorouracil 400mg/m² IV bolus, 5-fluorouracil 600mg/m2 22h IV infusion. Day 2: Leucovorin 200mg/m² 2h IV infusion, 5-fluorouracil 400mg/m² IV bolus, 5-fluorouracil 600mg/m² 22h IV infusion. Repeated every 2 weeks
DRUG	Doxorubicin	Day 1: Doxorubicin 50mg/m² iv infusion. Repeated every 3 weeks.

Timeline

• Start date: 2007-03-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2007-05-10
• Last updated: 2010-09-20

Locations

4 sites across 4 countries: China, South Korea, Taiwan, Thailand