Lung Cancer Clinical Trial

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

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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Full 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.

View Eligibility Criteria

Eligibility 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

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

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

25

Study ID:

NCT00031785

Recruitment Status:

Completed

Sponsor:

Wake Forest University Health Sciences

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There is 1 Location for this study

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Comprehensive Cancer Center at Wake Forest University
Winston-Salem North Carolina, 27157, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

25

Study ID:

NCT00031785

Recruitment Status:

Completed

Sponsor:


Wake Forest University Health Sciences

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