Randomized Double Blind Trial Of Megestrol Acetate Versus Placebo For The Treatment Of Inoperable Hepatocellular Carcinoma
- Compare the overall survival of patients with inoperable hepatocellular carcinoma
treated with megestrol vs placebo.
- Compare the quality of life of patients treated with these drugs.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to participating center. Patients are randomized to 1 of 2
- Arm I: Patients receive oral megestrol twice daily for 1 year.
- Arm II: Patients receive an oral placebo twice daily for 1 year. Quality of life is
assessed at baseline and then monthly for 1 year.
PROJECTED ACCRUAL: A minimum of 300 patients (200 for arm I and 100 for arm II) will be
accrued for this study.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Survival measured weekly
Pierce Chow, MD, PhD, MBBS, FRCS, FAMS
National Cancer Centre, Singapore
United States: Federal Government