Radiation Therapy in Preventing Central Nervous System (CNS) Metastases in Patients With Non-Small Cell Lung Cancer
NCT ID: NCT00048997
Last Updated: 2018-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
356 participants
INTERVENTIONAL
2002-09-30
2016-12-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prophylactic cranial irradiation (PCI)
Radiation therapy
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.
Observation
Observation
Observation
Interventions
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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.
Observation
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of stage IIIA or IIIB non-small cell lung cancer
* Complete response, partial response, or stable disease after definitive locoregional therapy (with surgery and/or radiation therapy, with or without chemotherapy (chemotherapy alone does not constitute definitive therapy))
* No more than 16 weeks since prior therapy
* No progressive disease
* No extracranial distant metastatic disease
* No suspicion of CNS metastases by MRI or CT scan
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* No other malignancy within the past 3 years except nonmelanoma skin cancer
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent anticancer biologic therapy
Chemotherapy
* See Disease Characteristics
* No concurrent anticancer cytotoxic chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* No prior cranial irradiation
Surgery
* See Disease Characteristics
Other
* Recovered from all prior therapies
* No concurrent enrollment on any other phase III study that has progression-free, disease-free, or overall survival as an endpoint
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Elizabeth M. Gore, MD
Role: STUDY_CHAIR
Medical College of Wisconsin
James A. Bonner, MD
Role: STUDY_CHAIR
University of Alabama at Birmingham
Locations
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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
Countries
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References
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Gondi V, Paulus R, Bruner D, et al.: Prognostic significance of QOL deterioration during early lung cancer survivorship: secondary analysis of RTOG 0212 and 0214. [Abstract] J Clin Oncol 29 (Suppl 15): A-6061, 2011.
Gore EM, Bae K, Wong SJ, Sun A, Bonner JA, Schild SE, Gaspar LE, Bogart JA, Werner-Wasik M, Choy H. Phase III comparison of prophylactic cranial irradiation versus observation in patients with locally advanced non-small-cell lung cancer: primary analysis of radiation therapy oncology group study RTOG 0214. J Clin Oncol. 2011 Jan 20;29(3):272-8. doi: 10.1200/JCO.2010.29.1609. Epub 2010 Dec 6.
Sun A, Bae K, Gore EM, Movsas B, Wong SJ, Meyers CA, Bonner JA, Schild SE, Gaspar LE, Bogart JA, Werner-Wasik M, Choy H. Phase III trial of prophylactic cranial irradiation compared with observation in patients with locally advanced non-small-cell lung cancer: neurocognitive and quality-of-life analysis. J Clin Oncol. 2011 Jan 20;29(3):279-86. doi: 10.1200/JCO.2010.29.6053. Epub 2010 Dec 6.
Gore E. RTOG 0214: a phase III comparison of prophylactic cranial irradiation versus observation in patients with locally advanced non-small cell lung cancer. Clin Adv Hematol Oncol. 2005 Aug;3(8):625-6. No abstract available.
Sun A, Hu C, Wong SJ, Gore E, Videtic G, Dutta S, Suntharalingam M, Chen Y, Gaspar LE, Choy H. Prophylactic Cranial Irradiation vs Observation in Patients With Locally Advanced Non-Small Cell Lung Cancer: A Long-term Update of the NRG Oncology/RTOG 0214 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2019 Jun 1;5(6):847-855. doi: 10.1001/jamaoncol.2018.7220.
Other Identifiers
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CDR0000257200
Identifier Type: -
Identifier Source: secondary_id
ECOG-RTOG-0214
Identifier Type: -
Identifier Source: secondary_id
RTOG-0214
Identifier Type: -
Identifier Source: org_study_id
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