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Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer Clinical research trials and Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer. Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer  Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer
Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer
For Condition: Cachexia,limited stage small cell lung cancer,Anorexia,stage 2 non-small cell lung cancer,stage 1 non-small cell lung cancer,stage 3B non-small cell lung cancer,stage 3A non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Comprehensive Cancer Center of Wake Forest University
Synopsis: 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.
Details: OBJECTIVES: I. Determine the effect of megestrol on weight in patients receiving radiotherapy for lung cancer. II. Determine the quality of life of patients treated with this drug. PROTOCOL 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 maximum of 98 patients (49 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EdwardShaw, Study Chair, Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Additional Information:
Study ID Numbers: CDR0000069226; CCCWFU-98199,NCI-P02-0210
Study Start Date: September 2000
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031785
Other Stage 3a Non-Small Cell Lung Cancer Studies:
1. Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery
2. Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer
3. Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer
4. Cisplatin and Gemcitabine Plus Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
5. Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Related Studies:
Other stage 3A non-small cell lung cancer Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer
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