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Randomised Trial of Tamoxifen Versus Placebo for the Treatment of Inoperable Hepatocellular Carcinoma

Phase 3
10 Years
90 Years
Not Enrolling
Liver Cancer

Thank you

Trial Information

Randomised Trial of Tamoxifen Versus Placebo for the Treatment of Inoperable Hepatocellular Carcinoma

OBJECTIVES: I. Assess the therapeutic role of tamoxifen in patients with inoperable
hepatocellular carcinoma in terms of overall survival and quality of life.

OUTLINE: This is a randomized, double blind, placebo controlled study of tamoxifen. Patients
are randomized to one of 3 treatment arms. Arm I: Patients receive placebo orally twice
daily for one year. Arms II and III: Patients receive tamoxifen, at 1 of 2 different doses,
orally twice daily for one year. Quality of life is assessed before treatment and then
monthly thereafter. Patients are followed monthly until death.

PROJECTED ACCRUAL: This study will accrue 300 patients.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or radiologically confirmed inoperable
hepatocellular carcinoma Serum alfa-feto protein level at least 500 ug/L OR Positive
lipiodol uptake

PATIENT CHARACTERISTICS: Age: 10 to 90 Performance status: ECOG 0-3 Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine less than
1.7 mg/dL Other: No encephalopathy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemoembolization therapy for disease No prior systemic chemotherapy for disease Endocrine
therapy: Not specified Radiotherapy: Not specified Surgery: No prior surgery for disease
Other: No prior percutaneous injection

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Pierce Chow, MD, PhD, MBBS, FRCS, FAMS

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Centre, Singapore


United States: Federal Government

Study ID:




Start Date:

April 1997

Completion Date:

August 2009

Related Keywords:

  • Liver Cancer
  • localized unresectable adult primary liver cancer
  • advanced adult primary liver cancer
  • adult primary hepatocellular carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular