Tamoxifen in Treating Patients With Primary Liver Cancer
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.
|Study Design:||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|
|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.
|Prince of Wales Hospital|
|Shatin, New Territories, Hong Kong|
|University of Udayana|
|Sanglah, Denpasar, Bali, Indonesia|
|Universiti Kebangsaan Malaysia|
|Bangi, Malaysia, 43600|
|Wellington Cancer Centre|
|Wellington, New Zealand, 6039|
|National Cancer Institute - Karachi|
|Nishtar Medical College, Multan|
|National Cancer Centre - Singapore|
|Singapore, Singapore, 169608|
|Tan Tock Seng Hospital|
|Singapore, Singapore, 1130|
|Study Chair:||Pierce Chow, MD, PhD, MBBS, FRCS, FAMS||National Cancer Centre, Singapore|