Radiation Therapy, Temozolomide, and Irinotecan in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Study Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as temozolomide and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well radiation therapy, temozolomide, and irinotecan work in treating patients with newly diagnosed 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 |
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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 newly diagnosed supratentorial glioblastoma multiforme by surgical biopsy or excision.
- - No gliomas graded less than glioblastoma multiforme.
- - No recurrent malignant gliomas.
- - No tumor foci below the tentorium or beyond the cranial vault.
- - Study therapy must begin ≤ 5 weeks after surgery.
- - 18 and over.
- - Zubrod 0-1.
- - At least 8 weeks.
- - Absolute neutrophil count ≥ 1,500/mm^3.
- - Platelet count ≥ 100,000/mm^3.
- - Hemoglobin ≥ 10 g/dL* - Hematocrit ≥ 30%* NOTE: *Transfusion allowed.
- - Bilirubin ≤ 0.5 mg/dL.
- - ALT or AST ≤ 2 times upper limit of normal.
- - Creatinine ≤ 1.5 mg/dL.
- - BUN ≤ 25 mg/dL.
- - Not pregnant or nursing.
- - Negative pregnancy test.
- - Fertile patients must use effective double-barrier contraception during and for 2 months after study participation.
- - No AIDS.
- - No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or bladder.
- - No other major medical illness or psychiatric impairment that would preclude study participation.
- - No concurrent sargramostim (GM-CSF) Chemotherapy.
- - No other concurrent chemotherapy.
- - Concurrent steroid therapy allowed provided patient is on a stable or decreasing dose for at least 2 weeks before study entry.
- - No prior radiotherapy to the head or neck resulting in overlap of radiotherapy fields.
- - Prior radiotherapy for stage T1 glottic cancer allowed.
- - See Disease Characteristics.
- - Recovered from prior surgery.
- - No enzyme-inducing antiepileptic drugs within 14 days before the initiation of irinotecan.
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. |
NCT00099125 |
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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 |
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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. |
Radiation Therapy Oncology Group |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Frank S. Lieberman, MDChristina I. Tsien, MD |
| Principal Investigator Affiliation | University of PittsburghUniversity of Michigan Rogel Cancer Center |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other, NIH |
| Overall Status | Completed |
| Countries | United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Brain and Central Nervous System Tumors |
OBJECTIVES:
- - Compare overall survival of patients with newly diagnosed supratentorial glioblastoma multiforme treated with radiotherapy and temozolomide followed by temozolomide and irinotecan with historical controls from the RTOG database.
- - Determine the short- and long-term toxicity of this regimen in these patients.
- - Determine progression-free survival of patients treated with this regimen.
- - Chemoradiotherapy: Patients undergo radiotherapy once daily, 5 days a week, for 6 weeks.
- - Post-radiotherapy chemotherapy: Beginning 4-6 weeks after the completion of chemoradiotherapy, patients receive irinotecan IV on days 1 and 15 and oral temozolomide once daily on days 1-5.
Arms
Experimental: RT with chemotherapy + post-radiation chemotherapy
Radiation therapy (RT) with concurrent chemotherapy + post-radiation chemotherapy
Interventions
Drug: - irinotecan hydrochloride
Drug: - temozolomide
Procedure: - adjuvant therapy
Radiation: - radiation therapy
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
Foundation for Cancer Research and Education
Phoenix, Arizona, 85013
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Providence Saint Joseph Medical Center - Burbank
Burbank, California, 91505
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Saint Agnes Medical Center
Fresno, California, 93720
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Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, 92354
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Providence Holy Cross Cancer Center
Mission Hills, California, 91346-9600
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Pomona Valley Hospital Medical Center
Pomona, California, 91767
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Radiological Associates of Sacramento Medical Group, Inc.
Sacramento, California, 95815
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Yale Comprehensive Cancer Center at Yale University School of Medicine
New Haven, Connecticut, 06520-8032
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CCOP - Christiana Care Health Services
Newark, Delaware, 19718
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University of Florida Shands Cancer Center
Gainesville, Florida, 32610
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Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, 32207
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John B. Amos Community Cancer Center
Columbus, Georgia, 31904
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Regional Radiation Oncology Center at Rome
Rome, Georgia, 30165
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Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706
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Northwest Community Hospital
Arlington Heights, Illinois, 60005
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Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
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University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
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Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, 60426
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Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, 60153
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St. Francis Hospital and Health Centers
Beech Grove, Indiana, 46107
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Tulane Cancer Center
New Orleans, Louisiana, 70112
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CCOP - Ochsner
New Orleans, Louisiana, 70121
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University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
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Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, 48202
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West Michigan Cancer Center
Kalamazoo, Michigan, 49007
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Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, 39581
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Cancer Institute of Cape Girardeau
Cape Girardeau, Missouri, 63703
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CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65802
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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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Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, 63110
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Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska, 68114
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CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
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Dartmouth - Hitchcock Concord
Concord, New Hampshire, 03301
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Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
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Cancer Institute of New Jersey at the Cooper University Hospital
Camden, New Jersey, 08103
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Cooper Cancer Institute
Camden, New Jersey, 08103
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John F. Kennedy Medical Center
Edison, New Jersey, 08818
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Monmouth Medical Center
Long Branch, New Jersey, 07740
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Community Medical Center
Toms River, New Jersey, 08755
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University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, 87106
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Roswell Park Cancer Institute
Buffalo, New York, 14263
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Lipson Cancer and Blood Center at Rochester General Hospital
Rochester, New York, 14621
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James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
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Randolph Hospital
Asheboro, North Carolina, 27203
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Mission Hospitals - Memorial Campus
Asheville, North Carolina, 28801
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John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital
Eden, North Carolina, 27288
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Address
Wayne Radiation Oncology
Goldsboro, North Carolina, 27534
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Address
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, 27401
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Annie Penn Cancer Center
Reidsville, North Carolina, 27320
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Akron City Hospital
Akron, Ohio, 44304
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McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, 44307
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Radiation Oncology Center
Alliance, Ohio, 44601
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Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, 44710
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Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45267
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CCOP - Columbus
Columbus, Ohio, 43215
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Grandview Hospital
Dayton, Ohio, 45405
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David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, 45409
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Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
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Charles F. Kettering Memorial Hospital
Kettering, Ohio, 45429
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Address
Middletown Regional Hospital
Middletown, Ohio, 45044
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Address
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
Salem, Ohio, 44460
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Address
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, 45373
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Address
Cancer Treatment Center
Wooster, Ohio, 44691
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Address
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, 45385
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Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, 74136
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Legacy Mount Hood Medical Center
Glesham, Oregon, 97030
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Address
Providence Milwaukie Hospital
Milwaukie, Oregon, 97222
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Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center
Portland, Oregon, 97210
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Address
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, 97213
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CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
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Providence St. Vincent Medical Center
Portland, Oregon, 97225
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Institute of Oncology at Vilnius University
Portland, Oregon, 97227
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Legacy Meridian Park Hospital
Tualatin, Oregon, 97062
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Abington Memorial Hospital
Abington, Pennsylvania, 19001
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John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
Allentown, Pennsylvania, 18105
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St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, 18015
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Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
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UPMC Cancer Center - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601
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Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
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UPMC McKeesport
McKeesport, Pennsylvania, 15132
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Paoli Memorial Hospital
Paoli, Pennsylvania, 19301
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Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107
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Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141
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Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
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UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
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UPMC Cancer Center at UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
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UPMC St. Margaret
Pittsburgh, Pennsylvania, 15215
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Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15219
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UPMC - Shadyside
Pittsburgh, Pennsylvania, 15232
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UPMC - Passavant Hospital
Pittsburgh, Pennsylvania, 15237
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Cancer Center at St. Clair Memorial Hospital
Pittsburgh, Pennsylvania, 15243
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Address
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburg, Pennsylvania, 15213
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Reading Hospital and Medical Center
West Reading, Pennsylvania, 19612
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CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
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Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, 19096
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York Cancer Center at Wellspan Health
York, Pennsylvania, 17405
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Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
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CCOP - Upstate Carolina
Spartanburg, South Carolina, 29304
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Rapid City Regional Hospital
Rapid City, South Dakota, 57701
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Cottonwood Hospital Medical Center
Murray, Utah, 84107
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McKay-Dee Hospital Center
Ogden, Utah, 84403
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Utah Valley Regional Medical Center - Provo
Provo, Utah, 84603
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Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, 84106
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LDS Hospital
Salt Lake City, Utah, 84143
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Address
Dixie Regional Medical Center
St. George, Utah, 84770
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Green Mountain Oncology Group
Bennington, Vermont, 05201
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Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, 05401
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Community Cancer Center at Rutland Regional Medical Center
Rutland, Vermont, 05701
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Address
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, 23298
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Address
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
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Southwest Washington Medical Center Cancer Center
Vancouver, Washington, 98668
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Address
North Star Lodge Cancer Center
Yakima, Washington, 98902
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Address
St. Vincent Hospital
Green Bay, Wisconsin, 54301
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Address
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
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Address
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
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Community Memorial Hospital
Menomonee Falls, Wisconsin, 53051
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Address
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
