Radiation Therapy With or Without Radiosurgery in Treating Patients With Brain Metastases

November 18, 2013 updated by: Radiation Therapy Oncology Group

A PHASE III TRIAL COMPARING WHOLE BRAIN IRRADIATION WITH VERSUS WITHOUT STEREOTACTIC RADIOSURGERY BOOST FOR PATIENTS WITH ONE TO THREE UNRESECTED BRAIN METASTASES

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether giving radiation therapy during surgery is more effective than standard radiation therapy in treating brain metastases.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without radiosurgery in treating patients with brain metastases that cannot be removed during surgery.

Study Overview

Status

Completed

Conditions

Metastatic Cancer

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Compare the overall survival of patients with one unresected brain metastasis treated with conventional whole brain radiotherapy (WBRT) with vs. without a stereotactic radiosurgery (SRS) boost. II. Compare sites of recurrence and cause of death in these patients treated with WBRT followed by SRS vs. WBRT alone.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center and extracranial disease (yes or no). Patients are randomized to one of two treatment arms. Arm I: Patients receive fractionated external beam whole brain irradiation (WBRT) 5 days each week for 3 weeks. Both portals are treated during each radiotherapy session. Patients who still have a solitary lesion with a diameter no greater than 4.0 cm also receive stereotactic radiosurgery within 7 days of completing WBRT. Arm II: Patients receive WBRT only. Patients are followed every 3 months for 1 year, then every 4 months for 2 years, and then annually.

PROJECTED ACCRUAL: A total of 262 patients will be accrued over 2.5-3.75 years for this study. The study may close early if interim analysis after 33% and 67% of patients have been followed for 6 months produces significant results. After 6/14/99 an additional 46 patients with a solitary brain metastasis only will be accrued.

Study Type

Interventional

Enrollment (Actual)

333

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Tom Baker Cancer Center - Calgary
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Cross Cancer Institute
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 4E6
    - BC Cancer Agency
- New Brunswick
  - Moncton, New Brunswick, Canada, E1C 8X3
    - Doctor Leon Richard Oncology Centre
  - Saint John, New Brunswick, Canada, E2L 4L2
    - Saint John Regional Hospital
- Newfoundland and Labrador
  - St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
    - Newfoundland Cancer Treatment and Research Foundation
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1V7
    - Nova Scotia Cancer Centre
- Ontario
  - Hamilton, Ontario, Canada, L8V 5C2
    - Cancer Care Ontario-Hamilton Regional Cancer Centre
  - Kingston, Ontario, Canada, K7L 5P9
    - Kingston Regional Cancer Centre
  - London, Ontario, Canada, N6A 4L6
    - Cancer Care Ontario-London Regional Cancer Centre
  - Ottawa, Ontario, Canada, K1H 1C4
    - Ottawa Regional Cancer Centre - General Campus
  - Sudbury, Ontario, Canada, P3E 5J1
    - Northeastern Ontario Regional Cancer Centre, Sudbury
  - Thunder Bay, Ontario, Canada, P7A 7T1
    - Northwestern Ontario Regional Cancer Centre, Thunder Bay
  - Toronto, Ontario, Canada, M4N 3M5
    - Toronto Sunnybrook Regional Cancer Centre
  - Toronto, Ontario, Canada, M5G 2M9
    - Princess Margaret Hospital
- Quebec
  - Fleurimont, Quebec, Canada, J1H 5N4
    - Centre Universitaire de Sante de l'Estrie - Site Fleurimont
  - Montreal, Quebec, Canada, H2W 1S6
    - McGill University Department of Oncology
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7N 4H4
    - Saskatoon Cancer Centre
United States
- Alabama
  - Birmingham, Alabama, United States, 35294
    - University Of Alabama Comprehensive Cancer Center
  - Huntsville, Alabama, United States, 35801
    - Huntsville Hospital System
  - Huntsville, Alabama, United States, 35801
    - Comprehensive Cancer Institute of Huntsville
  - Mobile, Alabama, United States, 36640
    - Urology Associates - Mobile AL
  - Mobile, Alabama, United States, 36640-0460
    - Mobile Infirmary Medical Center
  - Mobile, Alabama, United States, 36652
    - MBCCOP - Gulf Coast
  - Montgomery, Alabama, United States, 36106-2801
    - Alabama Oncology, LLC
  - Tuscallosa, Alabama, United States, 35401
    - Radiation Oncology Associates of West Alabama
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Providence Cancer Therapy Center
- Arizona
  - Tucson, Arizona, United States, 85724
    - Arizona Cancer Center
- California
  - Concord, California, United States, 94524-4110
    - Mount Diablo Medical Center
  - Fresno, California, United States, 93720
    - California Cancer Center
  - Fresno, California, United States, 93720
    - Saint Agnes Cancer Center
  - Glendale, California, United States, 91204
    - Glendale Memorial Hospital and Health Center
  - Greenbrae, California, United States, 94904
    - Sutter Health Western Division Cancer Research Group
  - La Jolla, California, United States, 92093-0658
    - University of California San Diego Cancer Center
  - Loma Linda, California, United States, 92354
    - Loma Linda University Medical Center
  - Long Beach, California, United States, 90822
    - Veterans Affairs Medical Center - Long Beach
  - Los Angeles, California, United States, 90033-0800
    - USC/Norris Comprehensive Cancer Center
  - Los Angeles, California, United States, 90095-1781
    - Jonsson Comprehensive Cancer Center, UCLA
  - Los Angeles, California, United States, 91010
    - Beckman Research Institute, City of Hope
  - Los Angeles, California, United States, 90027
    - Kaiser Permanente Medical Center - Los Angeles
  - Oakland, California, United States, 94609-3305
    - CCOP - Bay Area Tumor Institute
  - Pomona, California, United States, 91767
    - Cancer Care Center
  - Sacramento, California, United States, 95816
    - Radiation Oncology Center - Sacramento
  - San Diego, California, United States, 92101-1492
    - Radiation Medical Group, Inc.
  - San Francisco, California, United States, 94115-0128
    - UCSF Cancer Center and Cancer Research Institute
  - San Jose, California, United States, 95128
    - O'Connor Hospital
  - Santa Rosa, California, United States, 95403
    - CCOP - Santa Rosa Memorial Hospital
  - Stanford, California, United States, 94305
    - Stanford University
- Colorado
  - Colorado Springs, Colorado, United States, 80909
    - Memorial Hospital Cancer Center
  - Denver, Colorado, United States, 80262
    - University of Colorado Cancer Center
- Connecticut
  - Bridgeport, Connecticut, United States, 06610
    - Bridgeport Hospital
  - Norwalk, Connecticut, United States, 06856
    - Whittingham Cancer Center
- Delaware
  - Wilmington, Delaware, United States, 19899
    - CCOP - Christiana Care Health Services
- District of Columbia
  - Washington, District of Columbia, United States, 20307-5000
    - Walter Reed Army Medical Center
- Florida
  - Clearwater, Florida, United States, 33757-0210
    - Lykes Center for Radiation Therapy
  - Daytona Beach, Florida, United States, 32114
    - Halifax Medical Center
  - Fort Myers, Florida, United States, 33901
    - Radiation Therapy Associates - Fort Myers
  - Gainesville, Florida, United States, 32610-0296
    - University of Florida Health Science Center
  - Melbourne, Florida, United States, 32901
    - Health First Holmes Regional Medical Center
  - Miami, Florida, United States, 33136
    - Sylvester Cancer Center, University of Miami
  - Miami, Florida, United States, 33176-2197
    - Baptist Hospital of Miami
  - Miami, Florida, United States, 33125
    - Veterans Affairs Medical Center - Miami
  - Miami Beach, Florida, United States, 33140
    - CCOP - Mount Sinai Medical Center
  - Orange Park, Florida, United States, 32073
    - Florida Radiation Oncology Group
  - Orlando, Florida, United States, 32806
    - MD Anderson Cancer Center Orlando
  - Panama City, Florida, United States, 32405-4587
    - Gulf Coast Cancer Treatment Center
  - Panama City, Florida, United States, 32401
    - Bay Medical Center
  - Pensacola, Florida, United States, 32514
    - West Florida Cancer Institute - Pensacola
  - Saint Petersburg, Florida, United States, 33701
    - Bayfront Medical Center
  - Sarasota, Florida, United States, 34233
    - Sarasota Radiation and Medical Oncology Center
  - Tallahassee, Florida, United States, 32308
    - Tallahassee Memorial HealthCare
  - Tampa, Florida, United States, 33612
    - H. Lee Moffitt Cancer Center and Research Institute
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Emory University Hospital - Atlanta
  - Atlanta, Georgia, United States, 30342-1701
    - CCOP - Atlanta Regional
  - Columbus, Georgia, United States, 31902
    - Medical Center/John B. Amos Community Cancer Center
  - Rome, Georgia, United States, 30161
    - InterCommunity Cancer Center at Rome
- Illinois
  - Arlington Heights, Illinois, United States, 60005
    - Northwest Community Hospital
  - Chicago, Illinois, United States, 60611
    - Northwestern Memorial Hospital
  - Chicago, Illinois, United States, 60637
    - University of Chicago Cancer Research Center
  - Decatur, Illinois, United States, 62526
    - CCOP - Central Illinois
  - Elgin, Illinois, United States, 60123
    - Provena St. Joseph Hospital- Regional Cancer Care Center
  - Harvey, Illinois, United States, 60426
    - Ingalls Memorial Hospital
  - Maywood, Illinois, United States, 60153
    - Loyola University Medical Center
  - Park Ridge, Illinois, United States, 60068
    - Lutheran General Cancer Care Center
  - Peoria, Illinois, United States, 61636
    - Methodist Medical Center of Illinois
- Indiana
  - Anderson, Indiana, United States, 46016
    - St. John's Medical Center
  - Indianapolis, Indiana, United States, 46202
    - Veterans Affairs Medical Center - Indianapolis (Roudebush)
  - Indianapolis, Indiana, United States, 46206-1367
    - Clarion Health Partners Inc.
  - Indianapolis, Indiana, United States, 46219
    - Community Hospitals of Indianapolis - Regional Cancer Center
  - Muncie, Indiana, United States, 47303-3499
    - Ball Memorial Hospital
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46617
    - St. Joseph's Radiation Oncology Center
- Iowa
  - Dubuque, Iowa, United States, 52001
    - Wendt Regional Cancer Center of Finley Hospital
  - Iowa City, Iowa, United States, 52242
    - University of Iowa Hospitals and Clinics
- Kentucky
  - Lexington, Kentucky, United States, 40511-1093
    - Veterans Affairs Medical Center - Lexington
  - Lexington, Kentucky, United States, 40536-0084
    - Albert B. Chandler Medical Center, University of Kentucky
  - Louisville, Kentucky, United States, 40202
    - James Graham Brown Cancer Center
  - Louisville, Kentucky, United States, 40215
    - Louisville Radiation Oncology
  - Madisonville, Kentucky, United States, 42431
    - Merle M. Mahr Cancer Center
  - Paducah, Kentucky, United States, 42001
    - Western Baptist Hospital
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Mary Bird Perkins Cancer Center
  - Lafayette, Louisiana, United States, 70501
    - Romagosa Radiation Oncology Center
  - New Orleans, Louisiana, United States, 70112
    - Tulane University School of Medicine
  - New Orleans, Louisiana, United States, 70112
    - MBCCOP - LSU Medical Center
  - New Orleans, Louisiana, United States, 70121
    - CCOP - Ochsner
- Maine
  - Portland, Maine, United States, 04102
    - Maine Medical Center
- Maryland
  - Annapolis, Maryland, United States, 21401
    - Anne Arundel Oncology Center
  - Baltimore, Maryland, United States, 21225
    - Sinai Hospital of Baltimore
  - Baltimore, Maryland, United States, 21204
    - Greater Baltimore Medical Center and Cancer Center
  - Baltimore, Maryland, United States, 21225
    - Harbor Hospital Center
  - Baltimore, Maryland, United States, 21237
    - Radiation Oncology Affiliates of Maryland, P.A.
  - Baltimore, Maryland, United States, 21231
    - Johns Hopkins Oncology Center
  - Salisbury, Maryland, United States, 21801
    - Peninsula Regional Medical Center
- Massachusetts
  - Hyannis, Massachusetts, United States, 02601
    - Cape Cod Hospital
  - Jamaica Plain, Massachusetts, United States, 02130
    - Veterans Affairs Medical Center - Boston (Jamaica Plain)
- Michigan
  - Ann Arbor, Michigan, United States, 48109-0752
    - University of Michigan Comprehensive Cancer Center
  - Ann Arbor, Michigan, United States, 48106
    - CCOP - Ann Arbor Regional
  - Detroit, Michigan, United States, 48201
    - Barbara Ann Karmanos Cancer Institute
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48432
    - McLaren Regional Cancer Center
  - Kalamazoo, Michigan, United States, 49007-3731
    - CCOP - Kalamazoo
  - Lansing, Michigan, United States, 48909
    - Sparrow Regional Cancer Center
  - Marquette, Michigan, United States, 49855
    - Marquette General Hospital
  - Midland, Michigan, United States, 48670
    - MidMichigan Medical Center - Midland
  - Royal Oak, Michigan, United States, 48073
    - William Beaumont Hospital
  - Saginaw, Michigan, United States, 48601
    - St. Mary's Medical Center
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic Cancer Center
  - Saint Louis Park, Minnesota, United States, 55416
    - CCOP - Metro-Minnesota
- Mississippi
  - Tupelo, Mississippi, United States, 38801
    - North Mississippi Medical Center/Cancer Center
- Missouri
  - Columbia, Missouri, United States, 65203
    - Ellis Fischel Cancer Center - Columbia
  - Kansas City, Missouri, United States, 64131
    - CCOP - Kansas City
  - Saint Louis, Missouri, United States, 63110-0250
    - St. Louis University Health Sciences Center
  - Saint Louis, Missouri, United States, 63110
    - Mallinckrodt Institute of Radiology
  - Springfield, Missouri, United States, 65807
    - CCOP - Cancer Research for the Ozarks
  - Springfield, Missouri, United States, 65807
    - Cancer Research for the Ozarks
- Montana
  - Billings, Montana, United States, 59101
    - CCOP - Montana Cancer Consortium
- Nebraska
  - Omaha, Nebraska, United States, 68114
    - Methodist Cancer Center - Omaha
  - Omaha, Nebraska, United States, 68198-7400
    - Nebraska Health System
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - CCOP - Southern Nevada Cancer Research Foundation
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - Norris Cotton Cancer Center
  - Manchester, New Hampshire, United States, 03103
    - Elliot Regional Cancer Center
- New Jersey
  - Camden, New Jersey, United States, 08103
    - Cooper Cancer Institute
  - East Orange, New Jersey, United States, 07018-1095
    - Veterans Affairs Medical Center - East Orange
  - Edison, New Jersey, United States, 08818
    - John F. Kennedy Medical Center
  - Elizabeth, New Jersey, United States, 07201
    - Trinitas Hospital - Jersey Street Campus
  - Long Branch, New Jersey, United States, 07740
    - Monmouth Medical Center
  - Millville, New Jersey, United States, 08332
    - South Jersey Hospital - Millville
  - Mount Holly, New Jersey, United States, 08060
    - Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
  - New Brunswick, New Jersey, United States, 08901
    - Cancer Institute Of New Jersey
  - Newark, New Jersey, United States, 07112
    - Newark Beth Israel Medical Center
  - Pomona, New Jersey, United States, 08240
    - Atlantic City Medical Center
  - Toms River, New Jersey, United States, 08755
    - Community Medical Center
  - Trenton, New Jersey, United States, 08629
    - St. Francis Medical Center
  - Warren, New Jersey, United States, 07059
    - Associated Radiologists, P.A.
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - Saint Joseph Medical Center
- New York
  - Albany, New York, United States, 12208
    - Cancer Center of Albany Medical Center
  - Bronx, New York, United States, 10461
    - Albert Einstein Comprehensive Cancer Center
  - Brooklyn, New York, United States, 11203
    - State University of New York Health Science Center at Brooklyn
  - Brooklyn, New York, United States, 11215-3609
    - New York Methodist Hospital
  - Buffalo, New York, United States, 14263-0001
    - Roswell Park Cancer Institute
  - Clifton Springs, New York, United States, 14432
    - Finger Lakes Radiation Oncology, P.C.
  - Manhasset, New York, United States, 11030
    - CCOP - North Shore University Hospital
  - New York, New York, United States, 10021
    - Memorial Sloan-Kettering Cancer Center
  - New York, New York, United States, 10003
    - Beth Israel Medical Center
  - New York, New York, United States, 10016
    - NYU School of Medicine's Kaplan Comprehensive Cancer Center
  - New York, New York, United States, 10032
    - Herbert Irving Comprehensive Cancer Center
  - Plattsburgh, New York, United States, 12901
    - Champlain Valley Physicians Hospital Medical Center
  - Poughkeepsie, New York, United States, 12601
    - Vassar Brothers Hospital
  - Rochester, New York, United States, 14642
    - University of Rochester Cancer Center
  - Valhalla, New York, United States, 10595
    - New York Medical College
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599-7295
    - Lineberger Comprehensive Cancer Center, UNC
  - Concord, North Carolina, United States, 28025
    - Northeast Medical Center
  - Greenville, North Carolina, United States, 27858-4354
    - East Carolina University School of Medicine
  - Hickory, North Carolina, United States, 28601
    - Catawba Memorial Hospital
  - Winston-Salem, North Carolina, United States, 27104-4241
    - CCOP - Southeast Cancer Control Consortium
  - Winston-Salem, North Carolina, United States, 27157-1082
    - Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
- North Dakota
  - Fargo, North Dakota, United States, 58122
    - Meritcare Roger Maris Cancer Center
  - Minot, North Dakota, United States, 58701
    - UNIMED Medical Center
- Ohio
  - Akron, Ohio, United States, 44302
    - Akron General Medical Center
  - Akron, Ohio, United States, 44309
    - Akron City Hospital
  - Cincinnati, Ohio, United States, 45219
    - Christ Hospital
  - Cleveland, Ohio, United States, 44106
    - University Hospitals of Cleveland
  - Cleveland, Ohio, United States, 44106-5065
    - Ireland Cancer Center
  - Columbus, Ohio, United States, 43206
    - CCOP - Columbus
  - Columbus, Ohio, United States, 43210
    - Arthur G. James Cancer Hospital - Ohio State University
  - Kettering, Ohio, United States, 45429
    - CCOP - Dayton
  - Toledo, Ohio, United States, 43623-3456
    - CCOP - Toledo Community Hospital Oncology Program
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73101
    - St. Anthony Hospital
  - Tulsa, Oklahoma, United States, 74104
    - St. John Medical Center
- Oregon
  - Portland, Oregon, United States, 97213
    - CCOP - Columbia River Program
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18103
    - Lehigh Valley Hospital
  - Bethlehem, Pennsylvania, United States, 18015
    - St. Luke's Hospital Regional Cancer Center
  - Danville, Pennsylvania, United States, 17822-2001
    - Geisinger Medical Center
  - Darby, Pennsylvania, United States, 19023
    - Mercy Catholic Medical Center, Mercy Fitzgerald Divison
  - Drexel Hill, Pennsylvania, United States, 19026
    - Delaware County Memorial Hospital
  - Hershey, Pennsylvania, United States, 17033
    - Penn State Geisinger Cancer Center
  - Philadelphia, Pennsylvania, United States, 19111
    - Fox Chase Cancer Center
  - Philadelphia, Pennsylvania, United States, 19104
    - University of Pennsylvania Cancer Center
  - Philadelphia, Pennsylvania, United States, 19104
    - Veterans Affairs Medical Center - Philadelphia
  - Philadelphia, Pennsylvania, United States, 19107
    - Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
  - Philadelphia, Pennsylvania, United States, 19141
    - Albert Einstein Cancer Center
  - Philadelphia, Pennsylvania, United States, 19102-1192
    - Hahnemann University Hospital
  - Pittsburgh, Pennsylvania, United States, 15224
    - Western Pennsylvania Hospital
  - Pittsburgh, Pennsylvania, United States, 15213
    - University of Pittsburgh Cancer Institute
  - Pittsburgh, Pennsylvania, United States, 15219
    - Mercy Hospital of Pittsburgh
  - Reading, Pennsylvania, United States, 19612-6052
    - Reading Hospital and Medical Center
  - Scranton, Pennsylvania, United States, 18501
    - Mercy Hospital Cancer Center - Scranton
  - Wilkes-Barre, Pennsylvania, United States, 18764
    - Wilkes Barre General Hospital
  - Wynnewood, Pennsylvania, United States, 19096
    - CCOP - MainLine Health
  - York, Pennsylvania, United States, 17315
    - York Hospital
- Rhode Island
  - Providence, Rhode Island, United States, 02908-4735
    - Roger Williams Medical Center/BUSM
- South Carolina
  - Charleston, South Carolina, United States, 29425-0721
    - Medical University of South Carolina
  - Greenville, South Carolina, United States, 29615
    - CCOP - Greenville
  - Spartanburg, South Carolina, United States, 29303
    - CCOP - Upstate Carolina
- South Dakota
  - Rapid City, South Dakota, United States, 57709
    - Rapid City Regional Hospital
- Tennessee
  - Jackson, Tennessee, United States, 38301
    - Jackson-Madison County General Hospital
  - Knoxville, Tennessee, United States, 37901
    - Baptist Regional Cancer Center - Knoxville
  - Memphis, Tennessee, United States, 38103
    - University of Tennessee, Memphis Cancer Center
  - Memphis, Tennessee, United States, 38117
    - CCOP - Baptist Cancer Institute
  - Nashville, Tennessee, United States, 37232-6838
    - Vanderbilt-Ingram Cancer Center
- Texas
  - Amarillo, Texas, United States, 79106
    - Harrington Cancer Center
  - Beaumont, Texas, United States, 77701
    - Julie and Ben Rogers Cancer Institute
  - Galveston, Texas, United States, 77555-0209
    - University of Texas Medical Branch
  - Houston, Texas, United States, 77030-4009
    - University of Texas - MD Anderson Cancer Center
  - Lackland Air Force Base, Texas, United States, 78236-5300
    - Wilford Hall - 59th Medical Wing
  - Lubbock, Texas, United States, 79410-1894
    - Joe Arrington Cancer Research and Treatment Center
  - Pasadena, Texas, United States, 77504
    - Bayshore Medical Center
  - Tyler, Texas, United States, 75701
    - East Texas Medical Center - Cancer Institute
- Utah
  - Saint George, Utah, United States, 84770
    - Dixie Regional Medical Center
  - Salt Lake City, Utah, United States, 84132
    - University of Utah Health Sciences Center
  - Salt Lake City, Utah, United States, 84143
    - LDS Hospital
- Vermont
  - Bennington, Vermont, United States, 05201
    - CCOP - Southwestern Vermont Regional Cancer Center
  - Burlington, Vermont, United States, 05401-3498
    - Vermont Cancer Center
  - Rutland, Vermont, United States, 05701
    - Green Mountain Oncology Group
- Virginia
  - Charlottesville, Virginia, United States, 22901
    - Martha Jefferson Hospital
  - Charlottesville, Virginia, United States, 22908
    - Cancer Center, University of Virginia HSC
  - Harrisonburg, Virginia, United States, 22801
    - RMH Regional Canter Center
  - Lynchburg, Virginia, United States, 24503
    - Virginia Baptist Hospital
  - Portsmouth, Virginia, United States, 23708-2197
    - Naval Medical Center, Portsmouth
- Washington
  - Seattle, Washington, United States, 98104
    - Swedish Cancer Institute
  - Seattle, Washington, United States, 98111
    - Virginia Mason Medical Center
  - Spokane, Washington, United States, 99210-0248
    - Deaconess Medical Center
  - Yakima, Washington, United States, 98902
    - Yakima Valley Memorial Hospital
- West Virginia
  - Wheeling, West Virginia, United States, 26003
    - Schiffler Cancer Center
- Wisconsin
  - Green Bay, Wisconsin, United States, 54307-3508
    - St. Vincent Hospital
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Medical Foundation
  - Madison, Wisconsin, United States, 53792
    - University of Wisconsin Comprehensive Cancer Center
  - Madison, Wisconsin, United States, 53713
    - Southern Wisconsin Radiotherapy Center
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Clinic
  - Menomonee Falls, Wisconsin, United States, 53051
    - Community Memorial Hospital
  - Milwaukee, Wisconsin, United States, 53226
    - Medical College of Wisconsin
  - Milwaukee, Wisconsin, United States, 53210
    - St. Joseph's Hospital
  - Milwaukee, Wisconsin, United States, 53211
    - Columbia Hospital
  - Milwaukee, Wisconsin, United States, 53215
    - St. Luke's Medical Center
  - Milwaukee, Wisconsin, United States, 53295
    - Veterans Affairs Medical Center - Milwaukee (Zablocki)
  - Racine, Wisconsin, United States, 53405
    - Southeastern Wisconsin Regional Cancer Center
  - Waukesha, Wisconsin, United States, 53188
    - Waukesha Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: No more than 1 unresected or subtotally resected brain metastasis lesion from histologically confirmed systemic malignancy Eligible only if surgical resection refused by patient or resection deemed inappropriate by patient's physician 1 intraparenchymal metastasis clearly defined on contrast enhanced MRI Maximum diameter of lesion no greater than 4.0 cm No leukemia or lymphoma Extracranial sites of primary metastatic disease allowed if no clinical or radiographic evidence of progression within 1 month prior to entry No metastasis to brainstem, midbrain, pons, or medulla No leptomeningeal metastasis by MRI or CSF evaluation No metastasis within 10 mm of optic nerves and chiasm (area must be excluded from high dose stereotactic radiosurgery boost field)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 70-100% Karnofsky Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 50,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Not specified Renal: Not specified Other: Neurologic status 0-2 No major medical or psychiatric contraindication to protocol entry Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy for systemic cancer Endocrine therapy: Concurrent hormonal therapy, including tamoxifen, allowed Radiotherapy: No prior cranial radiotherapy Surgery: Prior subtotal resection allowed Other: No other concurrent treatment for brain metastasis until recurrence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 Whole brain radiation therapy (WBRT) to 37.5 Gy/15 fractions/2.5 Gy once daily, 5 days/week followed by radiosurgery to all metastases	Radiation: radiation therapy Radiation: stereotactic radiosurgery Procedure: surgical procedure
Active Comparator: Arm 2 WBRT to 37.5 Gy/15 fractions/2.5 Gy once daily, 5 days/week	Radiation: radiation therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: David W. Andrews, MD, FACS, Sidney Kimmel Cancer Center at Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Hazard LJ, Jensen RL, Shrieve DC. Role of stereotactic radiosurgery in the treatment of brain metastases. Am J Clin Oncol. 2005 Aug;28(4):403-10. doi: 10.1097/01.coc.0000158438.79665.bb.
Andrews DW, Scott CB, Sperduto PW, Flanders AE, Gaspar LE, Schell MC, Werner-Wasik M, Demas W, Ryu J, Bahary JP, Souhami L, Rotman M, Mehta MP, Curran WJ Jr. Whole brain radiation therapy with or without stereotactic radiosurgery boost for patients with one to three brain metastases: phase III results of the RTOG 9508 randomised trial. Lancet. 2004 May 22;363(9422):1665-72. doi: 10.1016/S0140-6736(04)16250-8.
Sperduto PW, Scott C, Andrews D: Stereotactic radiosurgery with whole brain radiation therapy improves survival in patients with brain metastases: report of Radiation Therapy Oncology Group phase III study 95-08. [Abstract] Int J Radiat Oncol Biol Phys 54(2 suppl 1): 3, 2002.
Sperduto P, Scott C, Andrews D, et al.: Preliminary report of RTOG 95-08: a phase III trial comparing whole brain irradiation alone versus whole brain irradiation plus stereotactic radiosurgery for patients with two or three unresected brain metastases. [Abstract] Int J Radiat Oncol Biol Phys 48: A-6, 113, 2000.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1996

Primary Completion (Actual)

January 1, 2002

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

April 12, 2004

First Posted (Estimate)

April 13, 2004

Study Record Updates

Last Update Posted (Estimate)

November 19, 2013

Last Update Submitted That Met QC Criteria

November 18, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

tumors metastatic to brain

Additional Relevant MeSH Terms

Other Study ID Numbers

RTOG-9508
CDR0000064522

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

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Study Locations

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Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

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Description

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Design Details

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Study record dates

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Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Metastatic Cancer

Clinical Trials on radiation therapy

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