Radiation Therapy in Preventing CNS Metastases in Patients With Non-Small Cell Lung Cancer - Full Text View

Purpose

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	Intervention	Phase
Lung Cancer	Other: clinical observation Radiation: radiation therapy	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	A Phase III Comparison Of Prophylactic Cranial Irradiation Versus Observation In Patients With Locally Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Neuropsychological impact of prophylactic cranial irradiation (PCI) [ Designated as safety issue: No ]
Impact of PCI on quality of life [ Designated as safety issue: No ]
Impact of PCI on incidence of CNS metastases [ Designated as safety issue: No ]

Estimated Enrollment:	1058
Study Start Date:	September 2002
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I Patients undergo prophylactic cranial irradiation 5 days a week for 3 weeks.	Radiation: radiation therapy Given 5 days a week for 3 weeks
No Intervention: Arm II Patients undergo observation.	Other: clinical observation Patients undergo observation.

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 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 annually thereafter.

PROJECTED ACCRUAL: A total of 1,058 patients (529 per treatment arm) will be accrued for this study within 36 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of stage IIIA or IIIB non-small cell lung cancer
- Complete response, partial response, or stable disease after definitive locoregional therapy (thoracic radiotherapy) with or without systemic chemotherapy and/or surgery (chemotherapy alone is not considered 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048997

Locations

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

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

Investigators

Study Chair:	Elizabeth M. Gore, MD	Medical College of Wisconsin
Study Chair:	James A. Bonner, MD	University of Alabama at Birmingham

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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. 2010 Dec 6; [Epub ahead of print]

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. 2010 Dec 6; [Epub ahead of print]

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.

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.

Responsible Party:	Walter John Curran, Jr, Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:	NCT00048997 History of Changes
Other Study ID Numbers:	CDR0000257200, RTOG-0214, ECOG-RTOG-0214
Study First Received:	November 12, 2002
Last Updated:	June 17, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms

Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013