CompletedPhase 3NCT00031785

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

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.

Checked against the public recordLast updated Sep 9, 2021 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 3
U.S. locations1
SponsorWake Forest University Health Sciences
01
Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Phase 3
Sponsor
Wake Forest University Health Sciences
Interventions being studied
Drug: megestrol acetate; Radiation: radiation therapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 9, 2021. Always confirm current availability with the study team.

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