Megestrol in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT00041275|
Recruitment Status : Completed
First Posted : January 28, 2003
Last Update Posted : September 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Drug: megestrol acetate||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Official Title:||Randomized Double Blind Trial Of Megestrol Acetate Versus Placebo For The Treatment Of Inoperable Hepatocellular Carcinoma|
|Study Start Date :||May 2002|
|Primary Completion Date :||June 2007|
|Study Completion Date :||August 2011|
- Survival measured weekly
- Quality of life as measured by EORTC quality of life instrument monthly
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): NCT00041275
|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|
|National Cancer Centre - Singapore|
|Singapore, Singapore, 169608|
|Changi General Hospital|
|Singapore, Singapore, 529889|
|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|