S0001 RT and Carmustine With or Without O6BG in Patients With New Glioblastoma Multiforme or Gliosarcoma
Study Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. O6-benzylguanine may help carmustine kill more tumor cells by making tumor cells more sensitive to the drug. It is not yet known whether radiation therapy and carmustine are more effective with or without O6-benzylguanine. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus carmustine with or without O6-benzylguanine in treating patients who have newly diagnosed glioblastoma multiforme or gliosarcoma.
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 |
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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 | 18 Years and Over |
| Gender | All |
DISEASE CHARACTERISTICS:
- - Histologically confirmed glioblastoma multiforme or gliosarcoma.
- - Biopsy or surgical resection within the past 28 days.
- - MRI* with gadolinium performed before registration.
- - Patients who undergo a simple biopsy only require preoperative MRI* with gadolinium.
- - No more than 2 noncontiguous tumor sites based on T2-weighted MRI (in 3 dimensions)* - No prior radiotherapy-delivered cephalad to the interspace between the seventh cervical and the first thoracic vertebral body NOTE: *If an MRI is not medically feasible, patients may have a CT scan with contrast.
- - 18 and over.
- - Zubrod 0-2.
- - Not specified.
- - Absolute neutrophil count at least 3,000/mm^3.
- - Platelet count at least 100,000/mm^3.
- - Hemoglobin at least 8 g/dL.
- - Bilirubin no greater than 2 times upper limit of normal (ULN) - SGOT/SGPT no greater than 2 times ULN.
- - Alkaline phosphatase no greater than 2 times ULN.
- - PT/PTT no greater than 1.2 times ULN.
- - Not specified.
- - No severe cardiac disease, including any of the following: - Uncontrolled arrhythmias or conduction defects.
- - Major problems with edema (e.g., residual swelling in the legs from deep vein thrombosis) - Recent coronary artery disease.
- - Poorly controlled hypertension (i.e., diastolic blood pressure greater than 110 mm Hg and/or systolic blood pressure greater than 180 mm Hg) Pulmonary: - DLCO at least 70% of predicted.
- - No severe pulmonary disease.
- - HIV negative.
- - No severe Cushing's syndrome.
- - No known allergies to any of the study drugs.
- - No major psychiatric illness.
- - No poorly controlled diabetes complicated by steroid treatment.
- - No other medical illness that cannot be adequately controlled or that would preclude study participation.
- - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission.
- - Not pregnant or nursing.
- - Fertile patients must use effective contraception.
- - Not specified.
- - No prior chemotherapy.
- - No other concurrent antitumor chemotherapy.
- - No concurrent hormonal therapy except postmenopausal estrogen replacement therapy.
- - Corticosteroids at stable or decreasing dose for tumor edema allowed.
- - See Disease Characteristics.
- - No prior radiotherapy.
- - No other concurrent radiotherapy (including intensity-modulated radiotherapy) to the index lesion(s) Surgery: - See Disease Characteristics.
- - No concurrent antitumor surgery.
- - No other concurrent investigational drugs.
Trial Details
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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. |
NCT00017147 |
|
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 3 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
SWOG Cancer Research Network |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Deborah T. Blumenthal, MDAlexander M. Spence, MDKeith J. Stelzer, MD, PhD |
| Principal Investigator Affiliation | University of UtahUniversity of WashingtonCelilo Cancer Center at Mid-Columbia Medical Center |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other, NIH |
| Overall Status | Completed |
| Countries | United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Malignant Neoplasms of Eye, Brain and Other Parts of Central Nervous System |
OBJECTIVES:
- - Compare the overall survival, failure-free survival, and progression-free survival of patients with newly diagnosed glioblastoma multiforme or gliosarcoma treated with radiotherapy and carmustine with or without O6-benzylguanine.
- - Compare the frequency and severity of toxic effects of these regimens in these patients.
- - Correlate the survival of these patients with the expression of O6-alkylguanine-DNA alkyltransferase.
- - Arm I: Patients undergo radiotherapy daily 5 days a week over 7 weeks for a total of 34 fractions.
- - Arm II: Patients undergo radiotherapy as in arm I.
- I. Patients are followed at week 48, every 4 months for 1 year, and then every 6 months for 4 years.
Arms
Experimental: O6-BG + BCNU + Radiation Therapy
O6-BG: 120 mg/m^2 IV over 1 hour on day 1 of each cycle BCNU: 40 mg/m^2 IV over 1 hour on day 1 of each cycle 6 hours after O6-BG dose. Radiation Therapy: 5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions.
Active Comparator: BCNU + Radiation Therapy
BCNU: 40 mg/m^2 IV over 1 hour on day 1 of each cycle. Radiation Therapy: 5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions.
Interventions
Drug: - carmustine
40 mg/m^2 IV over 1 hour on day 1 of each cycle 6 hours after O6-BG dose for experimental arm with O6=BG. 200 mg/m^2 IV over 1 hour on day 2 of each cycle for the active comparator arm.
Radiation: - radiation therapy
5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions.
Drug: - O6-Benzylguanine
120 mg/m^2 IV over 1 hour on day 1 of each cycle
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
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Alaska Regional Hospital Cancer Center
Anchorage, Alaska, 99508
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Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006
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CCOP - Western Regional, Arizona
Phoenix, Arizona, 85006
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St. Joseph's Hospital and Medical Center
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Banner Thunderbird Medical Center
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North Bay Cancer Center
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Memorial Hospital Cancer Center
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St. Anthony Central Hospital
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University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, 80217-3364
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North Colorado Medical Center
Greeley, Colorado, 80631
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McKee Medical Center
Loveland, Colorado, 80539
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St. Anthony North Hospital
Westminster, Colorado, 80030
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Exempla Lutheran Medical Center
Wheat Ridge, Colorado, 80033
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West Florida Cancer Institute at West Florida Hospital - Pensacola
Pensacola, Florida, 32514
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Piedmont Hospital
Atlanta, Georgia, 30309
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CCOP - Atlanta Regional
Atlanta, Georgia, 30342
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Northside Hospital Cancer Center
Atlanta, Georgia, 30342
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Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342
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WellStar Cobb Hospital
Austell, Georgia, 30106
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Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, 30033
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Northeast Georgia Medical Center
Gainesville, Georgia, 30501
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Gwinnett Medical Center
Lawrenceville, Georgia, 30045
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Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta, Georgia, 30060
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Southern Regional Medical Center
Riverdale, Georgia, 30274
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Hematology Oncology Associates of Eastern Idaho
Idaho Falls, Idaho, 83404
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Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, 62002
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University of Illinois at Chicago Cancer Center
Chicago, Illinois, 60612
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Veterans Affairs Medical Center - Chicago Westside Hospital
Chicago, Illinois, 60612
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Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526
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Good Samaritan Regional Health Center
Mt. Vernon, Illinois, 62864
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Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, 62781-0001
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St. Francis Hospital and Health Centers
Beech Grove, Indiana, 46107
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Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, 52803
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Genesis Medical Center - West Campus
Davenport, Iowa, 52804
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Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720
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Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801
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Cancer Center of Kansas, P.A. - El Dorado
El Dorado, Kansas, 67042
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Veterans Affairs Medical Center - Kansas City
Kansas City, Kansas, 64128
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Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, 66160
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Cancer Center of Kansas - Kingman
Kingman, Kansas, 67068
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Southwest Medical Center
Liberal, Kansas, 67901
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Cancer Center of Kansas - Newton
Newton, Kansas, 67114
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Cancer Center of Kansas, P.A. - Parsons
Parsons, Kansas, 67357
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Pratt Cancer Center of Kansas
Pratt, Kansas, 67124
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Cancer Center of Kansas - Salina
Salina, Kansas, 67042
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Salina Regional Health Center
Salina, Kansas, 67401
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Stormont-Vail Cancer Center
Topeka, Kansas, 66604
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St. Francis Comprehensive Cancer Center
Topeka, Kansas, 66606
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Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152
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Associates in Womens Health
Wichita, Kansas, 67203
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Cancer Center of Kansas, P.A.
Wichita, Kansas, 67208
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Cancer Center of Kansas, P.A. - Wichita
Wichita, Kansas, 67214
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CCOP - Wichita
Wichita, Kansas, 67214
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Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214
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Wesley Medical Center
Wichita, Kansas, 67214
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Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156
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Baton Rouge General Regional Cancer Center
Baton Rouge, Louisiana, 70806
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Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, 70809
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MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
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Medical Center of Louisiana - New Orleans
New Orleans, Louisiana, 70112
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Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, 49017
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Mecosta County General Hospital
Big Rapids, Michigan, 49307
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CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
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Lacks Cancer Center at Saint Mary's Mercy Medical Center
Grand Rapids, Michigan, 49503
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Spectrum Health Cancer Care - Butterworth Campus
Grand Rapids, Michigan, 49503
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Metropolitan Hospital
Grand Rapids, Michigan, 49506
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Holland Community Hospital
Holland, Michigan, 49423
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Hackley Hospital
Muskegon, Michigan, 49443
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Northern Michigan Hospital
Petoskey, Michigan, 49770
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William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, 48073
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Munson Medical Center
Traverse City, Michigan, 49684
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University of Mississippi Medical Center
Jackson, Mississippi, 39216
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St. Francis Medical Center
Cape Girardeau, Missouri, 63701
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Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Gape Girardeau, Missouri, 63701
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Freeman Cancer Institute at Freeman Health System
Joplin, Missouri, 64804
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CCOP - Kansas City
Kansas City, Missouri, 64131
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St. John's Regional Health Center
Springfield, Missouri, 65804
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Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807
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CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, 63141
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David C. Pratt Cancer Center at St. John's Mercy
St. Louis, Missouri, 63141
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CCOP - Montana Cancer Consortium
Billings, Montana, 59101
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Deaconess Billings Clinic - Downtown
Billings, Montana, 59101
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Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, 59101
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Northern Rockies Radiation Oncology Center
Billings, Montana, 59101
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St. Vincent Healthcare
Billings, Montana, 59101
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Deaconess Billings Clinic Cancer Center
Billings, Montana, 59107
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Bozeman Deaconess Hospital
Bozeman, Montana, 59715
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Internal Medicine Associates of Bozeman
Bozeman, Montana, 59715
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St. James Community Hospital
Butte, Montana, 59701
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Great Falls Clinic
Great Falls, Montana, 59405
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Sletten Regional Cancer Institute
Great Falls, Montana, 59405
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St. Peter's Hospital
Helena, Montana, 59601
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Glacier Oncology, PLLC
Kalispell, Montana, 59901
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Kalispell Medical Oncology
Kalispell, Montana, 59901
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Eastern Montana Cancer Center
Miles City, Montana, 59301
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Address
Community Medical Center
Missoula, Montana, 59801
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Address
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, 59802
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Address
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, 59802
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Address
Good Samaritan Health Systems
Kearney, Nebraska, 68847
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James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
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Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, 28233
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Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534
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Adena Regional Medical Center
Chillicothe, Ohio, 54601
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Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
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Riverside Methodist Hospital Cancer Care
Columbus, Ohio, 43214
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CCOP - Columbus
Columbus, Ohio, 43215
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Grant Riverside Cancer Services
Columbus, Ohio, 43215
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Mount Carmel West Hospital
Columbus, Ohio, 43222
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Doctors Hospital at Ohio Health
Columbus, Ohio, 43228
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Grandview Hospital
Dayton, Ohio, 45405
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Good Samaritan Hospital
Dayton, Ohio, 45406
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David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, 45409
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Address
Samaritan North Cancer Care Center
Dayton, Ohio, 45415
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Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
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CCOP - Dayton
Dayton, Ohio, 45429
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Grady Memorial Hospital
Delaware, Ohio, 43015
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Community Oncology Group - Independence
Independence, Ohio, 44131
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Address
Charles F. Kettering Memorial Hospital
Kettering, Ohio, 45429
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Address
Fairfield Medical Center
Lancaster, Ohio, 43130
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Address
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, 45750
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Address
Middletown Regional Hospital
Middletown, Ohio, 45044
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Address
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, 43055
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Address
Mercy Medical Center Oncology Unit
Springfield, Ohio, 45504
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Address
Community Hospital of Springfield and Clark County
Springfield, Ohio, 45505
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Address
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, 45373
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Address
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
Westerville, Ohio, 43081
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Address
Cleveland Clinic - Wooster
Wooster, Ohio, 44691
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Address
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, 45385
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Address
Genesis - Good Samaritan Hospital
Zanesville, Ohio, 43701
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Address
Legacy Mount Hood Medical Center
Glesham, Oregon, 97030
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Address
Providence Milwaukie Hospital
Milwaukie, Oregon, 97222
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Address
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
Portland, Oregon, 97210
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Address
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, 97213
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Address
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
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Address
Providence St. Vincent Medical Center
Portland, Oregon, 97225
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Address
Institute of Oncology at Vilnius University
Portland, Oregon, 97227
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Address
Salem Hospital Regional Cancer Center
Salem, Oregon, 97309
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Address
Legacy Meridian Park Hospital
Tualatin, Oregon, 97062
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Address
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660
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Address
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
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Address
Wilford Hall Medical Center
Lackland AFB, Texas, 78236
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Address
CCOP - Scott and White Hospital
Temple, Texas, 76508
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Address
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112
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Address
Danville Regional Medical Center
Danville, Virginia, 24541
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Address
St. Joseph Hospital Community Cancer Center
Bellingham, Washington, 98225
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Address
Olympic Hematology and Oncology
Bremerton, Washington, 98310
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Address
St. Francis Hospital
Federal Way, Washington, 98003
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Address
Skagit Valley Hospital Cancer Care Center
Mt. Vernon, Washington, 98273
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Address
Capital Medical Center
Olympia, Washington, 98507
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Address
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98104
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Address
Group Health Central Hospital
Seattle, Washington, 98104
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Address
Harborview Medical Center
Seattle, Washington, 98104
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Address
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, 98114
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Address
University Cancer Center at University of Washington Medical Center
Seattle, Washington, 98195
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Address
North Puget Oncology at United General Hospital
Sedro-Wooley, Washington, 98284
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Address
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202
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Allenmore Hospital
Tacoma, Washington, 98405
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Address
CCOP - Northwest
Tacoma, Washington, 98405
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Address
St. Clare Hospital
Tacoma, Washington, 98499
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Address
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, 98668
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Address
Central Washington Hospital
Wenatchee, Washington, 98801
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Address
Wenatchee Valley Clinic
Wenatchee, Washington, 98801
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Address
Welch Cancer Center
Sheridan, Wyoming, 82801
