Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anorexia Cachexia Lung Cancer |
Drug: megestrol acetate Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Supportive Care |
| 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 |
| Study Start Date: | September 2000 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, North Carolina | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| Study Chair: | Edward G. Shaw, MD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00031785 History of Changes |
| Other Study ID Numbers: | CDR0000069226, CCCWFU-98199, NCI-P02-0210 |
| Study First Received: | March 8, 2002 |
| Last Updated: | August 20, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by Wake Forest University Baptist Medical Center:
|
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 |
Additional relevant MeSH terms:
|
Anorexia Cachexia Lung Neoplasms Signs and Symptoms, Digestive Signs and Symptoms Emaciation Weight Loss Body Weight Changes Body Weight Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Megestrol Megestrol Acetate Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Appetite Stimulants Central Nervous System Stimulants Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 21, 2013