Tamoxifen in Treating Patients With Primary Liver Cancer

Status Completed

Clinical Trial 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.

Clinical Trial 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

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00003424
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Completed
Phase	Phase 3
Start date	April 1997
Completion date	August 2009

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03213314` - HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies	N/A
Not yet recruiting	`NCT04931420` - Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels	Phase 2
Terminated	`NCT00788125` - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors	Phase 1/Phase 2
Completed	`NCT03756597` - PAN-study: Pan-Cancer Early Detection Study (PAN)
Recruiting	`NCT05160740` - Indocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer	N/A
Completed	`NCT01906021` - Study of New Software Used During Ablations	N/A
Terminated	`NCT04589884` - Intraoperative EXamination Using MAChine-learning-based HYperspectral for diagNosis & Autonomous Anatomy Assessment
Recruiting	`NCT05953337` - Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)	N/A
Enrolling by invitation	`NCT04466124` - Prospective Cohort Study of Liver Cancer Patients Treated With Proton Beam Therapy
Not yet recruiting	`NCT04053231` - Hepatocarcinoma Recurrence on the Liver Study - Part2
Active, not recruiting	`NCT02869217` - Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors	Phase 1
Completed	`NCT03059238` - Parecoxib Versus Celecoxib Versus Oxycodone in Pain Control for Transcatheter Chemoembolization Procedure	Phase 3
Recruiting	`NCT02632188` - Radical Surgery Followed by Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen for the Treatment of Hepatocellular Carcinoma	Phase 1/Phase 2
Recruiting	`NCT01388101` - Real-time Diagnosis of Serum LECT 2 in Patient With Liver Cancer Using Electronic Antibody Sensor (e- Ab Sensor)	N/A
Terminated	`NCT00903396` - Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer	Phase 2
Completed	`NCT01042041` - Sorafenib Tosylate and Chemoembolization in Treating Patients With Unresectable Liver Cancer	Phase 1
Completed	`NCT00980239` - HAI Irinotecan + IV Bevacizumab, Bevacizumab & Oxaliplatin or Bevacizumab & Cetuximab in Advanced Cancers Metastatic to Liver	Phase 1
Completed	`NCT00790569` - Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking	N/A
Terminated	`NCT00896467` - Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy	N/A
Completed	`NCT00543777` - Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease	Phase 1/Phase 2