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Tamoxifen in Treating Patients With Primary Liver Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003424
Recruitment Status : Completed
First Posted : August 4, 2004
Last Update Posted : June 26, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Liver Cancer Drug: tamoxifen citrate Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomised Trial of Tamoxifen Versus Placebo for the Treatment of Inoperable Hepatocellular Carcinoma
Study Start Date : April 1997
Actual Primary Completion Date : June 2000
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003424


Locations
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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
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Study Chair: Pierce Chow, MD, PhD, MBBS, FRCS, FAMS National Cancer Centre, Singapore
More Information
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ClinicalTrials.gov Identifier: NCT00003424    
Other Study ID Numbers: NMRC-AHCC01
CDR0000066444 ( Registry Identifier: PDQ (Physician Data Query) )
EU-98018
First Posted: August 4, 2004    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: August 2009
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:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
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