Radiation Therapy Followed by Carmustine in Treating Patients Who Have Supratentorial Glioblastoma Multiforme
Study Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by carmustine in treating patients who have supratentorial glioblastoma multiforme.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | N/A and Over |
| Gender | All |
DISEASE CHARACTERISTICS:
- - Histologically confirmed supratentorial glioblastoma multiforme by surgical biopsy or resection within 5 weeks of study.
- - Postoperative residual contrast enhancing tumor and resection tumor cavity together no greater than 60 mm in maximum diameter.
- - No well-differentiated or anaplastic astrocytomas or multifocal glioma.
- - No tumors originating in the brainstem.
- - No residual tumor within 10 mm of optic chiasm.
- - No recurrent glioblastoma multiforme.
- - Not specified.
- - Zubrod 0-1.
- - Not specified.
- - Hemoglobin greater than 9 g/dL.
- - Absolute neutrophil count greater than 1,500/mm^3.
- - Platelet count greater than 100,000/mm^3.
- - Bilirubin less than 2.0 mg/dL.
- - Serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) less than 2 times normal.
- - Creatinine less than 1.8 mg/dL.
- - Blood urea nitrogen (BUN) less than 30 mg/dL.
- - Chest x-ray normal OR.
- - Diffusion capacity of lung for carbon monoxide (DLCO) greater than 60% predicted.
- - Not pregnant or nursing.
- - Negative pregnancy test.
- - Fertile patients must use effective contraception.
- - Neurologic functional status 0-3.
- - No other prior malignancy within the past 5 years except carcinoma in situ of the cervix or bladder, ductal carcinoma in situ of the breast, or nonmelanomatous skin cancer.
- - Not specified.
- - Not specified.
- - Concurrent steroids allowed.
- - Not specified.
- - See Disease Characteristics.
Trial Details
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT00006386 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Radiation Therapy Oncology Group |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Robert M. Cardinale, MD |
| Principal Investigator Affiliation | MCV Hospitals |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other, NIH |
| Overall Status | Completed |
| Countries | Canada, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Brain and Central Nervous System Tumors |
OBJECTIVES:
- - Determine the overall and progression-free survival in patients with supratentorial glioblastoma multiforme treated with accelerated radiotherapy and conformal stereotactic radiotherapy boost followed by carmustine.
- - Determine the short and long-term toxicity of this regimen in these patients.
- - Determine the feasibility of this regimen in these patients.
Arms
Experimental: External beam radiotherapy with stereotactic boost
External beam radiotherapy (EBXRT): 50 Gy in 25 daily fractions of 2 Gy. Stereotactic radiotherapy (SRT) boost: 4 treatments of 5 or 7 Gy, once per week during weeks 3-6. Patients will not receive EBXRT on the SRT treatment days.
Interventions
Drug: - carmustine
Radiation: - radiation therapy
Radiation: - stereotactic radiosurgery
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
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Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, 35801
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Huntsville Hospital System
Huntsville, Alabama, 35807
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Address
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
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Address
Alabama Oncology, LLC
Montgomery, Alabama, 36106-3657
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Address
DCH Cancer Treatment Center
Tuscaloosa, Alabama, 35401
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Address
Foundation for Cancer Research and Education
Phoenix, Arizona, 85013
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Address
Mount Diablo Medical Center
Concord, California, 94524-4110
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Address
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
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Address
Saint Agnes Cancer Center
Fresno, California, 93720
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Address
California Cancer Center
Fresno, California, 93729-5100
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Address
Sutter Health West Cancer Research Group
Greenbrae, California, 94904
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Address
Loma Linda University Medical Center
Loma Linda, California, 92354
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Address
Veterans Affairs Medical Center - Long Beach
Long Beach, California, 90822
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Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90025-1781
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USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
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CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
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Huntington Cancer Center
Pasadena, California, 91105
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Robert and Beverly Lewis Family Cancer Care Center
Pomona, California, 91767
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Radiation Oncology Center - Sacramento
Sacramento, California, 95816
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Radiation Medical Group, Incorporated
San Diego, California, 92101
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UCSF Comprehensive Cancer Center
San Francisco, California, 94143-0128
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O'Connor Hospital
San Jose, California, 95128
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CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
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David Grant Medical Center
Travis Air Force Base, California, 94535
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Memorial Hospital Cancer Center
Colorado Springs, Colorado, 80909
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University of Colorado Cancer Center
Denver, Colorado, 80010
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Saint Mary's Hospital and Medical Center
Grand Junction, Colorado, 81502-1628
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Hospital of St. Raphael
New Haven, Connecticut, 06511
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CCOP - Christiana Care Health Services
Newark, Delaware, 19713
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University of Florida Health Science Center
Gainesville, Florida, 32610-0385
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Florida Radiation Oncology Group
Jacksonville, Florida, 32207
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Health First Holmes Regional Medical Center
Melbourne, Florida, 32901-3276
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CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140
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Veterans Affairs Medical Center - Miami
Miami, Florida, 33125
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Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
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Baptist Hospital of Miami
Miami, Florida, 33256-2110
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MD Anderson Cancer Center Orlando
Orlando, Florida, 32806-2134
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Bay Medical Center
Panama City, Florida, 32401
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Gulf Coast Cancer Treatment Center
Panama City, Florida, 32405-4587
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Sarasota Radiation and Medical Oncology Center
Sarasota, Florida, 34233
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Tallahassee Memorial Healthcare
Tallahassee, Florida, 32308
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H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
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Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
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CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
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Medical Center/John B. Amos Community Cancer Center
Columbus, Georgia, 31901
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Regional Radiation Oncology Center at Rome
Rome, Georgia, 30165
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MBCCOP - Hawaii
Honolulu, Hawaii, 96813
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Northwest Community Hospital
Arlington Heights, Illinois, 60005
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Northwestern Memorial Hospital
Chicago, Illinois, 60611
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CCOP - Central Illinois
Decatur, Illinois, 62526
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Ingalls Memorial Hospital
Harvey, Illinois, 60426
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Loyola University Medical Center
Maywood, Illinois, 60153
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Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068
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Methodist Medical Center of Illinois
Peoria, Illinois, 61636
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St. John's Medical Center
Anderson, Indiana, 46016
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Bloomington Hospital
Bloomington, Indiana, 47402
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Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
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Clarian Health Partners Inc.
Indianapolis, Indiana, 46206-1367
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Regional Cancer Center
Indianapolis, Indiana, 46219
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Ball Memorial Hospital
Muncie, Indiana, 47303-3499
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CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
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Wendt Regional Cancer Center of Finley Hospital
Dubuque, Iowa, 52001
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Central Baptist Hospital
Lexington, Kentucky, 40503
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Cancer Center at Lexington Clinic
Lexington, Kentucky, 40504
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Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
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James Graham Brown Cancer Center
Louisville, Kentucky, 40202
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Louisville Radiation Oncology
Louisville, Kentucky, 40215
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Merle M. Mahr Cancer Center
Madisonville, Kentucky, 42431
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Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
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Tulane University School of Medicine
New Orleans, Louisiana, 70112-2699
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MBCCOP - LSU Medical Center
New Orleans, Louisiana, 70112
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CCOP - Ochsner
New Orleans, Louisiana, 70121
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Maine Medical Center
Portland, Maine, 04102
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Anne Arundel Oncology Center
Annapolis, Maryland, 21401
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Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
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Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, 21204
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Harbor Hospital Center
Baltimore, Maryland, 21215-1290
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Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
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Peninsula Regional Medical Center
Salisbury, Maryland, 21801
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
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Cape Cod Hospital
Hyannis, Massachusetts, 02601
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Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
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CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
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University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
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Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
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Henry Ford Hospital
Detroit, Michigan, 48202
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Hurley Medical Center
Flint, Michigan, 48503
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McLaren Regional Cancer Center
Flint, Michigan, 48532-3685
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CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
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Marquette General Hospital
Marquette, Michigan, 49855
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MidMichigan Medical Center - Midland
Midland, Michigan, 48670
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CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
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William Beaumont Hospital
Royal Oak, Michigan, 48073
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William Beaumont Hospital - Troy
Troy, Michigan, 48098
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Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
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CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
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Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
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CCOP - Kansas City
Kansas City, Missouri, 64131
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Mallinckrodt Institute of Radiology
Saint Louis, Missouri, 63108
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St. Louis University Health Sciences Center
Saint Louis, Missouri, 63110-0250
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Cancer Research for the Ozarks
Springfield, Missouri, 65807
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CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
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CCOP - Montana Cancer Consortium
Billings, Montana, 59101
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CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
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Methodist Hospital Cancer Center - Omaha
Omaha, Nebraska, 68114
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Nebraska Health System
Omaha, Nebraska, 68198-7460
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CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
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Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
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Elliot Regional Cancer Center
Manchester, New Hampshire, 03103
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Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07019
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John F. Kennedy Medical Center
Edison, New Jersey, 08818
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Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, 07201
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Monmouth Medical Center
Long Branch, New Jersey, 07740-6395
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South Jersey Regional Cancer Center
Millville, New Jersey, 08332
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Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
Mount Holly, New Jersey, 08060
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Cancer Institute of New Jersey
New Brunswick, New Jersey, 38103-2807
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Newark Beth Israel Medical Center
Newark, New Jersey, 07112
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Atlantic City Medical Center
Pomona, New Jersey, 08240
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Valley Hospital
Ridgewood, New Jersey, 07450
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Community Medical Center
Toms River, New Jersey, 08755
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St. Francis Medical Center
Trenton, New Jersey, 08629
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Associated Radiologists, P.A.
Warren, New Jersey, 07059
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Radiation Oncology Associates of Albuquerque
Albuquerque, New Mexico, 87109
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Cancer Center of Albany Medical Center
Albany, New York, 12208
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State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
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New York Methodist Hospital
Brooklyn, New York, 11215
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Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
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Finger Lakes Radiation Oncology Center
Clifton Springs, New York, 14432
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CCOP - North Shore University Hospital
Manhasset, New York, 11030
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Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
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Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, 12901
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Vassar Brothers Medical Center
Poughkeepsie, New York, 12601
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Address
James P. Wilmot Cancer Center
Rochester, New York, 14642
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Address
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
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Address
Riverhill Radiation Oncology
Yonkers, New York, 10701
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Address
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
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Address
Northeast Medical Center
Concord, North Carolina, 28025
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Address
East Carolina University School of Medicine
Greenville, North Carolina, 27858-4354
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Address
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241
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Address
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082
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Address
Trinity Cancer Care Center
Minot, North Dakota, 58701
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Address
Akron General Medical Center
Akron, Ohio, 44302
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Address
Akron City Hospital
Akron, Ohio, 44304
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Address
Christ Hospital
Cincinnati, Ohio, 45219
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Barrett Cancer Center
Cincinnati, Ohio, 45267-0502
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Ireland Cancer Center
Cleveland, Ohio, 44106-5065
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University Hospitals of Cleveland
Cleveland, Ohio, 44106
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Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
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CCOP - Columbus
Columbus, Ohio, 43206
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Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
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CCOP - Dayton
Dayton, Ohio, 45429
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CCOP - Toledo Community Hospital
Toledo, Ohio, 43623-3456
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St. Anthony Hospital
Oklahoma City, Oklahoma, 73101
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
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St. John Health System
Tulsa, Oklahoma, 74104
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CCOP - Oklahoma
Tulsa, Oklahoma, 74136
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CCOP - Columbia River Program
Portland, Oregon, 97225
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Address
Lehigh Valley Hospital
Allentown, Pennsylvania, 18105
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St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, 18015
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Geisinger Medical Center
Danville, Pennsylvania, 17822-2001
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Mercy Fitzgerald Hospital
Darby, Pennsylvania, 19023
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Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
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Pocono Cancer Center
East Stroudsburg, Pennsylvania, 18301
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Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
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Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
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Veterans Affairs Medical Center - Philadelphia
Philadelphia, Pennsylvania, 19104
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Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
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Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
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Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141-3098
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University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
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Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15219
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Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
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Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
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Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, 18501
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Wilkes Barre General Hospital
Wilkes-Barre, Pennsylvania, 18764
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York Cancer Center
York, Pennsylvania, 17403
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Roger Williams Medical Center/BUSM
Providence, Rhode Island, 02908-4735
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CCOP - Greenville
Greenville, South Carolina, 29615
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CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
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Rapid City Regional Hospital
Rapid City, South Dakota, 57709
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Jackson-Madison County General Hospital
Jackson, Tennessee, 38301-3956
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University of Tennessee Cancer Institute
Memphis, Tennessee, 38103
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Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-5671
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Harrington Cancer Center
Amarillo, Texas, 79106
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University of Texas Medical Branch
Galveston, Texas, 77555-0209
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University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
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Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236-5300
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Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410-1894
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Bayshore Medical Center
Pasadena, Texas, 77504
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Dixie Regional Medical Center
Saint George, Utah, 84770
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University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
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Latter Day Saints Hospital
Salt Lake City, Utah, 84143
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Vermont Cancer Center
Burlington, Vermont, 05405-0075
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Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
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RMH Regional Cancer Center
Harrisonburg, Virginia, 22801
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Naval Medical Center, Portsmouth
Portsmouth, Virginia, 23708-2197
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Bon Secours - St. Mary's Hospital
Richmond, Virginia, 23226
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Massey Cancer Center
Richmond, Virginia, 23298-0058
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Virginia Mason Medical Center
Seattle, Washington, 98111
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Deaconess Medical Center
Spokane, Washington, 99204
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Yakima Valley Memorial Hospital
Yakima, Washington, 98902
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Schiffler Cancer Center
Wheeling, West Virginia, 26003
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Address
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301
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Address
St. Vincent Hospital
Green Bay, Wisconsin, 54307-3508
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Address
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, 54601
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Address
Southern Wisconsin Radiotherapy Center
Madison, Wisconsin, 53713
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Address
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
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Address
Marshfield Clinic
Marshfield, Wisconsin, 54449
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Address
Community Memorial Hospital
Menomonee Falls, Wisconsin, 53051
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Columbia Hospital
Milwaukee, Wisconsin, 53211
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St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
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Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
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Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
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All Saints Cancer Center
Racine, Wisconsin, 53405
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Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, 53188
International Sites
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Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
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Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
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Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
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Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, A1B 3V6
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Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
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Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
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Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9
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Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
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Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
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Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, P3E 5J1
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Address
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, P7A 7T1
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Address
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
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Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
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Address
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4
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Address
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L 4MI
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Address
McGill University
Montreal, Quebec, H2W 1S6
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Address
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, G1R 2J6
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Address
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
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Address
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
