Spots Global Cancer Trial Database for Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer

Study Description

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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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