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

NCT00471965 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 371

Last updated 2010-09-20

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Benedict Blayney · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • China
  • South Korea
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00471965 on ClinicalTrials.gov