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

Primary Purpose

Liver Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
megestrol acetate
Sponsored by
National Medical Research Council (NMRC), Singapore
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring localized unresectable adult primary liver cancer, advanced adult primary liver cancer, adult primary hepatocellular carcinoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of hepatocellular carcinoma (HCC) Histologically confirmed OR Meets 2 of the following criteria: Radiological evidence of HCC on CT scan, MRI, or ultrasound Serum alpha-fetoprotein level at least 400 µg/L Positive lipiodol retention Not amenable to surgery PATIENT CHARACTERISTICS: Age: 20 to 100 Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 5.8 mg/dL Renal: Creatinine less than 1.7 mg/dL Other: Not pregnant No clinical encephalopathy No other malignancy within the past 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemoembolization for HCC No prior systemic chemotherapy for HCC Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics No prior surgery for HCC Other: No prior percutaneous injection for HCC

Sites / Locations

  • Bangabandhu Sheikh Mujib Medical University
  • Rumah Sakit Sanglah
  • St. Vincent Hospital
  • Yangon General Hospital
  • Auckland City Hospital
  • Davao Doctors Hospital
  • National Cancer Centre - Singapore
  • Changi General Hospital
  • Chang-Gung Memorial Hospital - Taipei
  • Ramathibodi Hospital
  • National Cancer Institute
  • Cho Ray Hospital

Outcomes

Primary Outcome Measures

Survival measured weekly

Secondary Outcome Measures

Quality of life as measured by EORTC quality of life instrument monthly

Full Information

First Posted
July 8, 2002
Last Updated
September 19, 2013
Sponsor
National Medical Research Council (NMRC), Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT00041275
Brief Title
Megestrol in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Official Title
Randomized Double Blind Trial Of Megestrol Acetate Versus Placebo For The Treatment Of Inoperable Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2002
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Medical Research Council (NMRC), Singapore

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
localized unresectable adult primary liver cancer, advanced adult primary liver cancer, adult primary hepatocellular carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
megestrol acetate
Primary Outcome Measure Information:
Title
Survival measured weekly
Secondary Outcome Measure Information:
Title
Quality of life as measured by EORTC quality of life instrument monthly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of hepatocellular carcinoma (HCC) Histologically confirmed OR Meets 2 of the following criteria: Radiological evidence of HCC on CT scan, MRI, or ultrasound Serum alpha-fetoprotein level at least 400 µg/L Positive lipiodol retention Not amenable to surgery PATIENT CHARACTERISTICS: Age: 20 to 100 Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 5.8 mg/dL Renal: Creatinine less than 1.7 mg/dL Other: Not pregnant No clinical encephalopathy No other malignancy within the past 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemoembolization for HCC No prior systemic chemotherapy for HCC Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics No prior surgery for HCC Other: No prior percutaneous injection for HCC
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierce Chow, MD, PhD, MBBS, FRCS, FAMS
Organizational Affiliation
National Cancer Centre, Singapore
Official's Role
Study Chair
Facility Information:
Facility Name
Bangabandhu Sheikh Mujib Medical University
City
Dhaka
ZIP/Postal Code
1000
Country
Bangladesh
Facility Name
Rumah Sakit Sanglah
City
Denpasar
State/Province
Bali
ZIP/Postal Code
20114
Country
Indonesia
Facility Name
St. Vincent Hospital
City
Suwon
ZIP/Postal Code
442-060
Country
Korea, Republic of
Facility Name
Yangon General Hospital
City
Yangon
Country
Myanmar
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
5
Country
New Zealand
Facility Name
Davao Doctors Hospital
City
Davao City
Country
Philippines
Facility Name
National Cancer Centre - Singapore
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Facility Name
Chang-Gung Memorial Hospital - Taipei
City
Taipei
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
National Cancer Institute
City
Ha Noi
Country
Vietnam
Facility Name
Cho Ray Hospital
City
Ho Chi Minh City
Country
Vietnam

12. IPD Sharing Statement

Citations:
PubMed Identifier
21863030
Citation
Chow PK, Machin D, Chen Y, Zhang X, Win KM, Hoang HH, Nguyen BD, Jin MY, Lobo R, Findlay M, Lim CH, Tan SB, Gandhi M, Soo KC; Asia-Pacific Hepatocellular Carcinoma Trials Group. Randomised double-blind trial of megestrol acetate vs placebo in treatment-naive advanced hepatocellular carcinoma. Br J Cancer. 2011 Sep 27;105(7):945-52. doi: 10.1038/bjc.2011.333. Epub 2011 Aug 23.
Results Reference
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Megestrol in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

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