Spots Global Cancer Trial Database for Megestrol in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

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Trial Identification

Brief Title: Megestrol in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

Official Title: Randomized Double Blind Trial Of Megestrol Acetate Versus Placebo For The Treatment Of Inoperable Hepatocellular Carcinoma

Study ID: NCT00041275

Conditions

Liver Cancer

Interventions

megestrol acetate

Study Description

Brief Summary: RATIONALE: Estrogen can stimulate the growth of cancer cells. Hormone therapy using megestrol may fight liver cancer by blocking the uptake of estrogen. It is not yet known if megestrol is an effective treatment for liver cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in treating patients who have liver cancer that cannot be removed by surgery.

Detailed Description: OBJECTIVES: * 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 treatment arms. * 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.