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Tamoxifen in Treating Patients With Primary Liver Cancer
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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 |
| 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) |
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) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00003424
| 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 | |
| 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 ( Registry Identifier: PDQ (Physician Data Query) ) EU-98018 |
| Study First Received: | November 1, 1999 |
| Last Updated: | June 25, 2013 |
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 June 23, 2017