Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care, Treatment	Completed	Over 18	NCI	CCCWFU-98199 NCI-P02-0210, NCT00031785

Objectives

1. Determine the effect of megestrol on weight in patients receiving radiotherapy for lung cancer.
2. Determine the quality of life of patients treated with this drug.

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

Expected Enrollment

A total of 98 patients (49 per treatment arm) will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Wake Forest University Comprehensive Cancer Center

Edward Shaw, MD, Protocol chair		Ph: 336-713-6506; 800-446-2255 Email: eshaw@wfubmc.edu

Registry Information
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
Trial Start Date		2000-09-04
Registered in ClinicalTrials.gov		NCT00031785
Date Submitted to PDQ		2002-01-15
Information Last Verified		2006-07-17
NCI Grant/Contract Number		CA12197