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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00041275

Enrollment

300

Registered

2003-01-28

Start date

2002-05-31

Completion date

2011-08-31

Last updated

2013-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer

Keywords

localized unresectable adult primary liver cancer, advanced adult primary liver cancer, adult primary hepatocellular carcinoma

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.

Interventions

DRUGmegestrol acetate

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Diagnosis of hepatocellular carcinoma (HCC) * Histologically confirmed OR * Meets 2 of the following criteria: * Radiological evidence of HCC on CT scan, MRI, or ultrasound * Serum alpha-fetoprotein level at least 400 µg/L * Positive lipiodol retention * Not amenable to surgery PATIENT CHARACTERISTICS: Age: * 20 to 100 Performance status: * ECOG 0-3 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 5.8 mg/dL Renal: * Creatinine less than 1.7 mg/dL Other: * Not pregnant * No clinical encephalopathy * No other malignancy within the past 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemoembolization for HCC * No prior systemic chemotherapy for HCC Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * See Disease Characteristics * No prior surgery for HCC Other: * No prior percutaneous injection for HCC

Design outcomes

Primary

Measure	Time frame
Survival measured weekly	—

Secondary

Measure	Time frame
Quality of life as measured by EORTC quality of life instrument monthly	—

Countries

Bangladesh, Burma, Indonesia, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026