Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Determine the effect of megestrol on weight in patients receiving radiotherapy for lung cancer. Determine the quality of life of patients treated with this drug. 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. Arm I: Patients receive oral megestrol once daily beginning within the first 3 days of radiotherapy and continuing until 12 weeks after the completion of radiotherapy. Arm II: Patients receive oral placebo once daily beginning within the first 3 days of radiotherapy and continuing until 12 weeks after the completion of radiotherapy. In both arms, quality of life is assessed at baseline, at the completion of radiotherapy, and at 4, 8, 12, 16, and 20 weeks after the completion of radiotherapy. 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.

Official Title
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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

Conditions
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Anorexia, Cachexia, Lung Cancer

Intervention / Treatment
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* Drug: megestrol acetate
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed lung cancer Unresectable stage I-IIIB non-small cell lung cancer (NSCLC) Resected stage I-IIIB NSCLC Limited stage small cell lung cancer Planned radiotherapy with a total dose of at least 5,000 cGy in fraction sizes of no greater than 200 cGy each No distant metastases No significant ascites, pleural effusions, or edema that would inhibit oral food intake or invalidate weight determinations PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: More than 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No uncontrolled hypertension No active thromboembolic disease No myocardial infarction within the past 3 months No prior congestive heart failure or thromboembolic events Pulmonary: No prior pulmonary edema Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 3 years except curatively treated carcinoma in situ of the cervix or non-melanoma skin cancer No uncontrolled diabetes with glycosylated hemoglobin greater than 10% No Cushing's syndrome No dietary restrictions (e.g., salt, sugar, or lipid) No other serious medical or psychiatric illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Endocrine therapy Endocrine therapy: At least 12 months since prior corticosteroids, estrogens, progestins, or other steroid hormone except as antiemetic prior to chemotherapy No concurrent corticosteroids, estrogens, progestins, or other steroid hormone except as antiemetic prior to chemotherapy Radiotherapy: See Disease Characteristics No prior radiotherapy to lung Surgery: See Disease Characteristics More than 14 days since prior surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: megestrol acetate|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I non-small cell lung cancer, stage II non-small cell lung cancer, limited stage small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, anorexia, cachexia