Radiation Therapy in Preventing Central Nervous System (CNS) Metastases in Patients With Non-Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00048997|
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : October 6, 2014
Last Update Posted : February 17, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Radiation: Radiation therapy Other: Observation||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||356 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Comparison Of Prophylactic Cranial Irradiation (PCI) Versus Observation In Patients With Locally Advanced Non-Small Cell Lung Cancer|
|Study Start Date :||September 2002|
|Primary Completion Date :||December 2008|
|Study Completion Date :||December 2016|
Experimental: Prophylactic cranial irradiation (PCI)
Radiation: Radiation therapy
PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy.
- Overall Survival [ Time Frame: After all patients have been potentially followed for a minimum of 12 months ]Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 12 months.
- Neuropsychological Impact of Prophylactic Cranial Irradiation (PCI) [ Time Frame: After all patients have been potentially followed for a minimum of 12 months ]
- Impact of PCI on Quality of Life [ Time Frame: After all patients have been potentially followed for a minimum of 12 months ]
- Impact of PCI on Incidence of CNS Metastases [ Time Frame: After all patients have been potentially followed for a minimum of 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00048997
|United States, Arizona|
|Arizona Oncology Services Foundation|
|Phoenix, Arizona, United States, 85013|
|Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn|
|Scottsdale, Arizona, United States, 85251|
|Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea|
|Scottsdale, Arizona, United States, 85260|
|United States, Illinois|
|Resurrection Medical Center|
|Chicago, Illinois, United States, 60631|
|United States, Maine|
|Central Maine Comprehensive Cancer Center at Central Maine Medical Center|
|Lewiston, Maine, United States, 04240|
|Maine Center for Cancer Medicine and Blood Disorders - Scarborough|
|Scarborough, Maine, United States, 04074|
|United States, Maryland|
|Shore Regional Cancer Center at Memorial Hospital - Easton|
|Easton, Maryland, United States, 21601|
|United States, Massachusetts|
|MetroWest Medical Center - Framingham Union Hospital|
|Framingham, Massachusetts, United States, 01702|
|United States, Michigan|
|Josephine Ford Cancer Center at Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, New Jersey|
|Cancer Institute of New Jersey at Cooper University Hospital - Camden|
|Camden, New Jersey, United States, 08103|
|United States, Pennsylvania|
|Geisinger Cancer Institute at Geisinger Health|
|Danville, Pennsylvania, United States, 17822-0001|
|Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center|
|Wilkes-Barre, Pennsylvania, United States, 18711|
|United States, Utah|
|Huntsman Cancer Institute at University of Utah|
|Salt Lake City, Utah, United States, 84112|
|United States, Washington|
|North Star Lodge Cancer Center at Yakima Valley Memorial Hospital|
|Yakima, Washington, United States, 98902|
|Study Chair:||Elizabeth M. Gore, MD||Medical College of Wisconsin|
|Study Chair:||James A. Bonner, MD||University of Alabama at Birmingham|