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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of High Dose Tamoxifen versus Placebo in Patients with Inoperable Hepatocellular Carcinoma (Summary Last Modified 07/2000)

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	10 to 90		NMRC-AHCC01 EU-98018, NCT00003424

Trial Description

Purpose:

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.

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

Eligibility:

• 10-90 years old
• No previous chemotherapy or surgery for liver cancer
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomized to receive either tamoxifen or a placebo by mouth twice a day for 1 year. Quality of life will be assessed before treatment and then once a month. All patients will receive evaluations once a month.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

NMRC Asia-Pacific Hepatocellular Carcinoma Trials Group

Pierce Chow, MD, PhD, MBBS, FRCS, FAMS, Protocol chair		Ph: 65-6321-4051 Email: gsupc@sgh.com.sg

Registry Information
Official Title		Randomised Trial of Tamoxifen Versus Placebo for the Treatment of Inoperable Hepatocellular Carcinoma
Trial Start Date		1997-04-04
Trial Completion Date		2000-06-01
Registered in ClinicalTrials.gov		NCT00003424
Date Submitted to PDQ		1998-07-09
Information Last Verified		2009-08-17

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