Megestrol in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
RATIONALE: Estrogen can stimulate the growth of cancer cells. Hormone therapy using megestrol may fight liver cancer by blocking the uptake of estrogen. It is not yet known if megestrol is an effective treatment for liver cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in treating patients who have liver cancer that cannot be removed by surgery.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Randomized Double Blind Trial Of Megestrol Acetate Versus Placebo For The Treatment Of Inoperable Hepatocellular Carcinoma|
- Survival measured weekly [ Designated as safety issue: No ]
- Quality of life as measured by EORTC quality of life instrument monthly [ Designated as safety issue: No ]
|Study Start Date:||May 2002|
|Study Completion Date:||August 2011|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
- Compare the overall survival of patients with inoperable hepatocellular carcinoma treated with megestrol vs placebo.
- Compare the quality of life of patients treated with these drugs.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral megestrol twice daily for 1 year.
- Arm II: Patients receive an oral placebo twice daily for 1 year. Quality of life is assessed at baseline and then monthly for 1 year.
PROJECTED ACCRUAL: A minimum of 300 patients (200 for arm I and 100 for arm II) will be accrued for this study.
|Bangabandhu Sheikh Mujib Medical University|
|Dhaka, Bangladesh, 1000|
|Rumah Sakit Sanglah|
|Denpasar, Bali, Indonesia, 20114|
|Korea, Republic of|
|St. Vincent Hospital|
|Suwon, Korea, Republic of, 442-060|
|Yangon General Hospital|
|Auckland City Hospital|
|Auckland, New Zealand, 5|
|Davao Doctors Hospital|
|Davao City, Philippines|
|Changi General Hospital|
|Singapore, Singapore, 529889|
|National Cancer Centre - Singapore|
|Singapore, Singapore, 169608|
|Chang-Gung Memorial Hospital - Taipei|
|Taipei, Taiwan, 333|
|Bangkok, Thailand, 10400|
|National Cancer Institute|
|Ha Noi, Vietnam|
|Cho Ray Hospital|
|Ho Chi Minh City, Vietnam|
|Study Chair:||Pierce Chow, MD, PhD, MBBS, FRCS, FAMS||National Cancer Centre, Singapore|