drugset / Trial / NCT00471965

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

NCT00471965 ↗

Phase 3 Completed 371 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start
2007-03
Primary completion
2010-03
Completion
2010-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Subject Leucovorin Small molecule 200 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject fluorouracil Small molecule 400 mg/m2 Intravenous
Subject fluorouracil Small molecule 600 mg/m2 Intravenous