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Tracking Information | |||||
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First Received Date † | March 8, 2002 | ||||
Last Updated Date | May 9, 2009 | ||||
Start Date † | September 2000 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00031785 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer | ||||
Official Title † | A Phase III, Double-Blind, Randomized Study of the Effect of Megestrol Acetate on Weight and Health Related Quality of Life in Lung Cancer Patients Receiving Thoracic Radiation Therapy | ||||
Brief Summary | RATIONALE: Megestrol helps improve appetite. It is not yet known if megestrol is effective in limiting weight loss in patients who are undergoing radiation therapy. PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in limiting weight loss in patients who are undergoing radiation therapy for lung cancer. |
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Detailed Description | OBJECTIVES:
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to histology (non-small cell lung cancer vs small cell lung cancer), and type of treatment (radiotherapy vs radiotherapy and non-cisplatin-containing chemotherapy vs radiotherapy and cisplatin-containing chemotherapy). Patients are randomized to one of two treatment arms. All patients undergo thoracic radiotherapy beginning on week 1 and continuing for a total of 5-7 weeks.
Patients are followed at 4 and 8 weeks. PROJECTED ACCRUAL: A total of 98 patients (49 per treatment arm) will be accrued for this study. |
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Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Supportive Care | ||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | |||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00031785 | ||||
Responsible Party | |||||
Secondary IDs †† | CCCWFU-98199, NCI-P02-0210 | ||||
Study Sponsor † | Wake Forest University | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | July 2006 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |