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| Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) Eastern Cooperative Oncology Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00048997 |
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 |
Procedure: observation Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Phase III Comparison Of Prophylactic Cranial Irradiation Versus Observation In Patients With Locally Advanced Non-Small Cell Lung Cancer |
| Estimated Enrollment: | 1058 |
| Study Start Date: | September 2002 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Experimental
Patients undergo prophylactic cranial irradiation 5 days a week for 3 weeks.
|
Radiation: radiation therapy
Given 5 days a week for 3 weeks
|
|
Arm II: No Intervention
Patients undergo observation.
|
Procedure: observation
Patients undergo observation.
|
OBJECTIVES:
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.
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 |
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)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and 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 | |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | |
| Wilkes-Barre, Pennsylvania, United States, 18711 | |
| Geisinger Cancer Institute at Geisinger Health | |
| Danville, Pennsylvania, United States, 17822-0001 | |
| 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 | Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham |
More Information
| Responsible Party: | Radiation Therapy Oncology Group ( Walter John Curran, Jr ) |
| Study ID Numbers: | CDR0000257200, RTOG-0214, ECOG-RTOG-0214 |
| Study First Received: | November 12, 2002 |
| Last Updated: | April 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00048997 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
|
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasm Metastasis |
Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
