A Phase III Comparison Of Prophylactic Cranial Irradiation Versus Observation In Patients With Locally Advanced Non-Small Cell Lung Cancer
- Determine whether prophylactic cranial irradiation improves survival after effective
locoregional/systemic therapy in patients with stage IIIA or IIIB non-small cell lung
- 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
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 prophylatctic cranial irradiation 5 days a week for 3 weeks.
- Arm II: Patients undergo observation. Quality of life is assessed at baseline and at
months 6, 12, 24, 36, and 48.
Patients are followed 3 months during the first year, every 6 months for 2-3 years and then
PROJECTED ACCRUAL: A total of 1,058 patients (529 per treatment arm) will be accrued for
this study within 36 months.
Allocation: Randomized, Primary Purpose: Treatment
Elizabeth M. Gore, MD
Medical College of Wisconsin
United States: Federal Government
|Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center||Wilkes-Barre, Pennsylvania 18711|
|Josephine Ford Cancer Center at Henry Ford Hospital||Detroit, Michigan 48202|
|Maine Center for Cancer Medicine and Blood Disorders - Scarborough||Scarborough, Maine 04074|
|Geisinger Cancer Institute at Geisinger Health||Danville, Pennsylvania 17822-0001|
|Huntsman Cancer Institute at University of Utah||Salt Lake City, Utah 84112|
|North Star Lodge Cancer Center at Yakima Valley Memorial Hospital||Yakima, Washington 98902|
|Arizona Oncology Services Foundation||Phoenix, Arizona 85013|
|MetroWest Medical Center - Framingham Union Hospital||Framingham, Massachusetts 01702|
|Resurrection Medical Center||Chicago, Illinois 60631|
|Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea||Scottsdale, Arizona 85260|
|Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn||Scottsdale, Arizona 85251|
|Cancer Institute of New Jersey at Cooper University Hospital - Camden||Camden, New Jersey 08103|
|Central Maine Comprehensive Cancer Center at Central Maine Medical Center||Lewiston, Maine 04240|
|Shore Regional Cancer Center at Memorial Hospital - Easton||Easton, Maryland 21601|