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

NCT ID: NCT00031785

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-01
• Study Completion Date: 2002-09-11

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.

Conditions

Anorexia; Cachexia; Lung Cancer

Study Design

• Primary Study Purpose: SUPPORTIVE_CARE

Interventions

megestrol acetate

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward G. Shaw, MD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

CCCWFU-98199

Identifier Type: -

Identifier Source: secondary_id

NCI-P02-0210

Identifier Type: -

Identifier Source: secondary_id

REBACDR0000069226

Identifier Type: -

Identifier Source: org_study_id