Randomized Double Blind Trial Of Megestrol Acetate Versus Placebo For The Treatment Of Inoperable Hepatocellular Carcinoma
20 Years
N/A
Both
Liver Cancer
Trial Information
Randomized Double Blind Trial Of Megestrol Acetate Versus Placebo For The Treatment Of Inoperable Hepatocellular Carcinoma
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Survival measured weekly
Safety Issue:
No
Principal Investigator
Pierce Chow, MD, PhD, MBBS, FRCS, FAMS
Investigator Role:
Study Chair
Investigator Affiliation:
National Cancer Centre, Singapore
Authority:
United States: Federal Government
Study ID:
CDR0000069460
NCT ID:
NCT00041275
Start Date:
May 2002
Completion Date:
Related Keywords:
- Liver Cancer
- localized unresectable adult primary liver cancer
- advanced adult primary liver cancer
- adult primary hepatocellular carcinoma
- Liver Neoplasms
- Carcinoma, Hepatocellular
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