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Phase 3
18 Years
Not Enrolling
Metastatic Cancer

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Trial Information


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.

Inclusion Criteria

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

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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

David W. Andrews, MD, FACS

Investigator Role:

Study Chair

Investigator Affiliation:

Kimmel Cancer Center (KCC)


United States: Federal Government

Study ID:




Start Date:

January 1996

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • tumors metastatic to brain
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Akron City Hospital Akron, Ohio  44304
Arizona Cancer Center Tucson, Arizona  85724
Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Albert Einstein Comprehensive Cancer Center Bronx, New York  10461
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Mayo Clinic Cancer Center Rochester, Minnesota  55905
University of Alabama Comprehensive Cancer Center Birmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
University of Colorado Cancer Center Denver, Colorado  80262
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Emory University Hospital - Atlanta Atlanta, Georgia  30322
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Johns Hopkins Oncology Center Baltimore, Maryland  21287
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Cancer Center of Albany Medical Center Albany, New York  12208
State University of New York Health Science Center at Brooklyn Brooklyn, New York  11203
University of Rochester Cancer Center Rochester, New York  14642
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157-1082
Ireland Cancer Center Cleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Medical University of South Carolina Charleston, South Carolina  29425-0721
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Cancer Center, University of Virginia HSC Charlottesville, Virginia  22908
St. Luke's Medical Center Milwaukee, Wisconsin  53215
Sylvester Cancer Center, University of Miami Miami, Florida  33136
MBCCOP - LSU Medical Center New Orleans, Louisiana  70112
Hurley Medical Center Flint, Michigan  48503
East Carolina University School of Medicine Greenville, North Carolina  27858-4354
Vermont Cancer Center Burlington, Vermont  05401-3498
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Baptist Cancer Institute Memphis, Tennessee  38117
University of California San Diego Cancer Center La Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Sinai Hospital of Baltimore Baltimore, Maryland  21225
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
CCOP - North Shore University Hospital Manhasset, New York  11030
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer Center Memphis, Tennessee  38103
Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis, Indiana  46202
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East Orange East Orange, New Jersey  07018-1095
Hahnemann University Hospital Philadelphia, Pennsylvania  19102-1192
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
Baptist Regional Cancer Center - Knoxville Knoxville, Tennessee  37901
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
MD Anderson Cancer Center Orlando Orlando, Florida  32806
Loyola University Medical Center Maywood, Illinois  60153
CCOP - Ochsner New Orleans, Louisiana  70121
CCOP - Toledo Community Hospital Oncology Program Toledo, Ohio  43623-3456
Rapid City Regional Hospital Rapid City, South Dakota  57709
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
Henry Ford Hospital Detroit, Michigan  48202
Marshfield Clinic Marshfield, Wisconsin  54449
Medical College of Wisconsin Milwaukee, Wisconsin  53226
Huntsville Hospital System Huntsville, Alabama  35801
Urology Associates - Mobile AL Mobile, Alabama  36640
Alabama Oncology, LLC Montgomery, Alabama  36106-2801
Radiation Oncology Associates of West Alabama Tuscallosa, Alabama  35401
Providence Cancer Therapy Center Anchorage, Alaska  99508
Mount Diablo Medical Center Concord, California  94524-4110
California Cancer Center Fresno, California  93720
Saint Agnes Cancer Center Fresno, California  93720
Glendale Memorial Hospital and Health Center Glendale, California  91204
Sutter Health Western Division Cancer Research Group Greenbrae, California  94904
Loma Linda University Medical Center Loma Linda, California  92354
Veterans Affairs Medical Center - Long Beach Long Beach, California  90822
Kaiser Permanente Medical Center - Los Angeles Los Angeles, California  90027
Beckman Research Institute, City of Hope Los Angeles, California  91010
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
Cancer Care Center Pomona, California  91767
Radiation Oncology Center - Sacramento Sacramento, California  95816
O'Connor Hospital San Jose, California  95128
CCOP - Santa Rosa Memorial Hospital Santa Rosa, California  95403
Stanford University Stanford, California  94305
Memorial Hospital Cancer Center Colorado Springs, Colorado  80909
Bridgeport Hospital Bridgeport, Connecticut  06610
Whittingham Cancer Center Norwalk, Connecticut  06856
Lykes Center for Radiation Therapy Clearwater, Florida  33757-0210
Halifax Medical Center Daytona Beach, Florida  32114
Radiation Therapy Associates - Fort Myers Fort Myers, Florida  33901
University of Florida Health Science Center Gainesville, Florida  32610-0296
Health First Holmes Regional Medical Center Melbourne, Florida  32901
Baptist Hospital of Miami Miami, Florida  33176-2197
Florida Radiation Oncology Group Orange Park, Florida  32073
Gulf Coast Cancer Treatment Center Panama City, Florida  32405-4587
West Florida Cancer Institute - Pensacola Pensacola, Florida  32514
Bayfront Medical Center Saint Petersburg, Florida  33701
Sarasota Radiation and Medical Oncology Center Sarasota, Florida  34233
Medical Center/John B. Amos Community Cancer Center Columbus, Georgia  31902
InterCommunity Cancer Center at Rome Rome, Georgia  30161
Northwest Community Hospital Arlington Heights, Illinois  60005
Northwestern Memorial Hospital Chicago, Illinois  60611
Ingalls Memorial Hospital Harvey, Illinois  60426
Lutheran General Cancer Care Center Park Ridge, Illinois  60068
Methodist Medical Center of Illinois Peoria, Illinois  61636
CCOP - Central Illinois Springfield, Illinois  62526
St. John's Medical Center Anderson, Indiana  46016
Clarion Health Partners Inc. Indianapolis, Indiana  46206-1367
Community Hospitals of Indianapolis - Regional Cancer Center Indianapolis, Indiana  46219
Ball Memorial Hospital Muncie, Indiana  47303-3499
Memorial Hospital of South Bend South Bend, Indiana  46601
St. Joseph's Radiation Oncology Center South Bend, Indiana  46617
Wendt Regional Cancer Center of Finley Hospital Dubuque, Iowa  52001
Veterans Affairs Medical Center - Lexington Lexington, Kentucky  40511-1093
James Graham Brown Cancer Center Louisville, Kentucky  40202
Louisville Radiation Oncology Louisville, Kentucky  40215
Merle M. Mahr Cancer Center Madisonville, Kentucky  42431
Western Baptist Hospital Paducah, Kentucky  42001
Mary Bird Perkins Cancer Center Baton Rouge, Louisiana  70809
Romagosa Radiation Oncology Center Lafayette, Louisiana  70501
Tulane University School of Medicine New Orleans, Louisiana  70112
Maine Medical Center Portland, Maine  04102
Anne Arundel Oncology Center Annapolis, Maryland  21401
Greater Baltimore Medical Center and Cancer Center Baltimore, Maryland  21204
Harbor Hospital Center Baltimore, Maryland  21225
Radiation Oncology Affiliates of Maryland, P.A. Baltimore, Maryland  21237
Cape Cod Hospital Hyannis, Massachusetts  02601
Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain, Massachusetts  02130
McLaren Regional Cancer Center Flint, Michigan  48432
Marquette General Hospital Marquette, Michigan  49855
St. Mary's Medical Center Saginaw, Michigan  48601
Mallinckrodt Institute of Radiology Saint Louis, Missouri  63110
St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
Methodist Cancer Center - Omaha Omaha, Nebraska  68114
Elliot Regional Cancer Center Manchester, New Hampshire  03103
John F. Kennedy Medical Center Edison, New Jersey  08818
South Jersey Hospital - Millville Millville, New Jersey  08332
Newark Beth Israel Medical Center Newark, New Jersey  07112
Community Medical Center Toms River, New Jersey  08755
St. Francis Medical Center Trenton, New Jersey  08629
Saint Joseph Medical Center Albuquerque, New Mexico  87102
New York Methodist Hospital Brooklyn, New York  11215-3609
Finger Lakes Radiation Oncology, P.C. Clifton Springs, New York  14432
Beth Israel Medical Center New York, New York  10003
Champlain Valley Physicians Hospital Medical Center Plattsburgh, New York  12901
Vassar Brothers Hospital Poughkeepsie, New York  12601
New York Medical College Valhalla, New York  10595
Northeast Medical Center Concord, North Carolina  28025
Catawba Memorial Hospital Hickory, North Carolina  28601
Meritcare Roger Maris Cancer Center Fargo, North Dakota  58122
Akron General Medical Center Akron, Ohio  44302
Christ Hospital Cincinnati, Ohio  45219
University Hospitals of Cleveland Cleveland, Ohio  44106
CCOP - Columbus Columbus, Ohio  43206
CCOP - Dayton Kettering, Ohio  45429
St. John Medical Center Tulsa, Oklahoma  74104
CCOP - Columbia River Program Portland, Oregon  97213
Lehigh Valley Hospital Allentown, Pennsylvania  18103
St. Luke's Hospital Regional Cancer Center Bethlehem, Pennsylvania  18015
Mercy Catholic Medical Center, Mercy Fitzgerald Divison Darby, Pennsylvania  19023
Delaware County Memorial Hospital Drexel Hill, Pennsylvania  19026
Penn State Geisinger Cancer Center Hershey, Pennsylvania  17033
Albert Einstein Cancer Center Philadelphia, Pennsylvania  19141
Veterans Affairs Medical Center - Philadelphia Philadelphia, Pennsylvania  19104
Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224
Mercy Hospital of Pittsburgh Pittsburgh, Pennsylvania  15219
Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
Mercy Hospital Cancer Center - Scranton Scranton, Pennsylvania  18501
Wilkes Barre General Hospital Wilkes-Barre, Pennsylvania  18764
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
York Hospital York, Pennsylvania  17315
Roger Williams Medical Center/BUSM Providence, Rhode Island  02908-4735
CCOP - Greenville Greenville, South Carolina  29615
Jackson-Madison County General Hospital Jackson, Tennessee  38301
Harrington Cancer Center Amarillo, Texas  79106
Julie and Ben Rogers Cancer Institute Beaumont, Texas  77701
University of Texas Medical Branch Galveston, Texas  77555-1329
Wilford Hall - 59th Medical Wing Lackland Air Force Base, Texas  78236-5300
Joe Arrington Cancer Research and Treatment Center Lubbock, Texas  79410-1894
Bayshore Medical Center Pasadena, Texas  77504
East Texas Medical Center - Cancer Institute Tyler, Texas  75701
Dixie Regional Medical Center Saint George, Utah  84770
LDS Hospital Salt Lake City, Utah  84143
CCOP - Southwestern Vermont Regional Cancer Center Bennington, Vermont  05201
Green Mountain Oncology Group Rutland, Vermont  05701
Martha Jefferson Hospital Charlottesville, Virginia  22901
Virginia Baptist Hospital Lynchburg, Virginia  24503
Naval Medical Center, Portsmouth Portsmouth, Virginia  23708-2197
Virginia Mason Medical Center Seattle, Washington  98111
Swedish Cancer Institute Seattle, Washington  98104
Deaconess Medical Center Spokane, Washington  99210-0248
Yakima Valley Memorial Hospital Yakima, Washington  98902
St. Vincent Hospital Green Bay, Wisconsin  54307-3508
Gundersen Lutheran Medical Foundation La Crosse, Wisconsin  54601
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Southern Wisconsin Radiotherapy Center Madison, Wisconsin  53713
Community Memorial Hospital Menomonee Falls, Wisconsin  53051
Columbia Hospital Milwaukee, Wisconsin  53211
St. Joseph's Hospital Milwaukee, Wisconsin  53210
Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee, Wisconsin  53295
Southeastern Wisconsin Regional Cancer Center Racine, Wisconsin  53405
Waukesha Memorial Hospital Waukesha, Wisconsin  53188
MBCCOP - Gulf Coast Mobile, Alabama  36688
Herbert Irving Comprehensive Cancer Center New York, New York  10032
Comprehensive Cancer Institute of Huntsville Huntsville, Alabama  35801
Radiation Medical Group, Inc. San Diego, California  92101-1492
Veterans Affairs Medical Center - Miami Miami, Florida  33125
Bay Medical Center Panama City, Florida  32401
Tallahassee Memorial Healthcare Tallahassee, Florida  32308
Provena St. Joseph Hospital- Regional Cancer Care Center Elgin, Illinois  60123
Peninsula Regional Medical Center Salisbury, Maryland  21801
MidMichigan Medical Center - Midland Midland, Michigan  48670
William Beaumont Hospital Royal Oak, Michigan  48073
North Mississippi Medical Center/Cancer Center Tupelo, Mississippi  38801
Nebraska Health System Omaha, Nebraska  68105-1018
Trinitas Hospital - Jersey Street Campus Elizabeth, New Jersey  07201
Monmouth Medical Center Long Branch, New Jersey  07740-6395
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County Mount Holly, New Jersey  08060
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Atlantic City Medical Center Pomona, New Jersey  08240
Associated Radiologists, P.A. Warren, New Jersey  07059
St. Anthony Hospital Oklahoma City, Oklahoma  73101
University of Utah Health Sciences Center Salt Lake City, Utah  84132
RMH Regional Canter Center Harrisonburg, Virginia  22801
Schiffler Cancer Center Wheeling, West Virginia  26003
Cooper Cancer Institute Camden, New Jersey  08103
Mobile Infirmary Medical Center Mobile, Alabama  36640-0460
UNIMED Medical Center Minot, North Dakota  58701