Megestrol in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

Phase 3

Completed

• Conditions: Liver Cancer

• Registration Number: NCT00041275
• Lead Sponsor: National Medical Research Council (NMRC), Singapore

Brief Summary

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.

Detailed Description

OBJECTIVES:

* 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 Timeline

• Study Start: 2002-05
• Study First Submitted: 2002-07-08
• Status Verified: 2002-09
• Study First Submitted QC: 2003-01-27
• Study First Posted: 2003-01-28
• Primary Completion: 2007-06
• Study Completion: 2011-08
• Last Update Submitted: 2013-09-19
• Last Update Posted: 2013-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival measured weekly

Secondary Outcome Measures

Name	Time	Method
Quality of life as measured by EORTC quality of life instrument monthly

Trial Locations

Locations (12)

Changi General Hospital; 🇸🇬 Singapore, Singapore

Rumah Sakit Sanglah; 🇮🇩 Denpasar, Bali, Indonesia

Yangon General Hospital; 🇲🇲 Yangon, Myanmar

Davao Doctors Hospital; 🇵🇭 Davao City, Philippines

National Cancer Centre - Singapore; 🇸🇬 Singapore, Singapore

National Cancer Institute; 🇻🇳 Ha Noi, Vietnam

Chang-Gung Memorial Hospital - Taipei; 🇨🇳 Taipei, Taiwan

Cho Ray Hospital; 🇻🇳 Ho Chi Minh City, Vietnam

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

St. Vincent Hospital; 🇰🇷 Suwon, Korea, Republic of

Bangabandhu Sheikh Mujib Medical University; 🇧🇩 Dhaka, Bangladesh

Ramathibodi Hospital; 🇹🇭 Bangkok, Thailand