Spots Global Cancer Trial Database for Radiation Therapy in Preventing Central Nervous System (CNS) Metastases in Patients With Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: Radiation Therapy in Preventing Central Nervous System (CNS) Metastases in Patients With Non-Small Cell Lung Cancer
Official Title: A Phase III Comparison Of Prophylactic Cranial Irradiation (PCI) Versus Observation In Patients With Locally Advanced Non-Small Cell Lung Cancer
Study ID: NCT00048997
Conditions
Study Description
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if giving radiation therapy to the head is effective in preventing CNS metastases in patients who have stage III non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying how well radiation therapy to the head works in preventing CNS metastases in patients who have been previously treated for stage III non-small cell lung cancer.
Detailed Description: OBJECTIVES: * Determine whether prophylactic cranial irradiation improves survival after effective locoregional/systemic therapy in patients with stage IIIA or IIIB non-small cell lung cancer. * Determine the neuropsychologic impact of this therapy in these patients. * Assess quality of life of patients receiving this therapy. * Determine the impact of this therapy on the incidence of CNS metastases in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (IIIA vs IIIB), histology (non-squamous cell vs squamous cell), and prior surgery (yes vs no). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo prophylactic cranial irradiation 5 days a week for 3 weeks. * Arm II: Patients undergo observation. Patients are followed 3 months during the first year, every 6 months for 2-3 years and then annually thereafter. Quality of life is assessed at baseline and at months 6, 12, 24, 36, and 48. PROJECTED ACCRUAL: A total of 1,058 patients (529 per treatment arm) will be accrued for this study within 36 months.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Oncology Services Foundation, Phoenix, Arizona, United States
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn, Scottsdale, Arizona, United States
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea, Scottsdale, Arizona, United States
Resurrection Medical Center, Chicago, Illinois, United States
Central Maine Comprehensive Cancer Center at Central Maine Medical Center, Lewiston, Maine, United States
Maine Center for Cancer Medicine and Blood Disorders - Scarborough, Scarborough, Maine, United States
Shore Regional Cancer Center at Memorial Hospital - Easton, Easton, Maryland, United States
MetroWest Medical Center - Framingham Union Hospital, Framingham, Massachusetts, United States
Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, United States
Cancer Institute of New Jersey at Cooper University Hospital - Camden, Camden, New Jersey, United States
Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania, United States
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima, Washington, United States
Contact Details
Name: Elizabeth M. Gore, MD
Affiliation: Medical College of Wisconsin
Role: STUDY_CHAIR
Name: James A. Bonner, MD
Affiliation: University of Alabama at Birmingham
Role: STUDY_CHAIR
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