A Phase 3 interventional study of megestrol acetate in Liver Cancer, sponsored by National Medical Research Council (NMRC), Singapore. Completed at 12 sites in 10 countries. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-09-20.
Sponsored by National Medical Research Council (NMRC), Singapore · Phase 3, Interventional, and Treatment
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.
OBJECTIVES:
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.
PROJECTED ACCRUAL: A minimum of 300 patients (200 for arm I and 100 for arm II) will be accrued for this study.
DISEASE CHARACTERISTICS:
Diagnosis of hepatocellular carcinoma (HCC)
Meets 2 of the following criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Survival measured weekly
Quality of life as measured by EORTC quality of life instrument monthly
This study is completed, as verified in Sep 2002. You cannot join it, but the record below documents what was studied.
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National Medical Research Council (NMRC), Singapore