Tamoxifen in Treating Patients With Primary Liver Cancer - Full Text View

Purpose

RATIONALE: Estrogen can stimulate the growth of cancer cells. Hormone therapy using tamoxifen may fight liver cancer by blocking the absorption of estrogen. It is not yet known whether receiving tamoxifen is more effective than no further therapy in treating patients with primary liver cancer.

PURPOSE: Randomized phase III trial to compare high-dose tamoxifen with no further treatment in treating patients with liver cancer that cannot be surgically removed.

Condition	Intervention	Phase
Liver Cancer	Drug: tamoxifen citrate	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	Randomised Trial of Tamoxifen Versus Placebo for the Treatment of Inoperable Hepatocellular Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: Tamoxifen Tamoxifen citrate

Genetic and Rare Diseases Information Center resources: Liver Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):


Estimated Enrollment:	300
Study Start Date:	April 1997
Study Completion Date:	August 2009
Primary Completion Date:	June 2000 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	10 Years to 90 Years (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003424

Locations


Hong Kong
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Indonesia
University of Udayana
Sanglah, Denpasar, Bali, Indonesia
Malaysia
Universiti Kebangsaan Malaysia
Bangi, Malaysia, 43600
New Zealand
Wellington Cancer Centre
Wellington, New Zealand, 6039
Pakistan
National Cancer Institute - Karachi
Karachi, Pakistan
Nishtar Medical College, Multan
Multan, Pakistan
Singapore
Tan Tock Seng Hospital
Singapore, Singapore, 1130
National Cancer Centre - Singapore
Singapore, Singapore, 169608

Sponsors and Collaborators

National Medical Research Council (NMRC), Singapore

Investigators


Study Chair:	Pierce Chow, MD, PhD, MBBS, FRCS, FAMS	National Cancer Centre, Singapore

More Information


ClinicalTrials.gov Identifier:	NCT00003424 History of Changes
Other Study ID Numbers:	NMRC-AHCC01 CDR0000066444 EU-98018
Study First Received:	November 1, 1999
Last Updated:	June 25, 2013
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):


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

Additional relevant MeSH terms:


Carcinoma, Hepatocellular Liver Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases	Tamoxifen Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 30, 2016