New combo shows promise for rare adrenal cancers
NCT ID NCT04394858
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
This study tests whether adding olaparib to the standard chemotherapy temozolomide helps control advanced pheochromocytoma or paraganglioma—rare neuroendocrine tumors that have spread or can't be removed surgically. About 46 adults with these cancers will be randomly assigned to receive either temozolomide alone or temozolomide plus olaparib. The goal is to see if the combination slows cancer growth better than the standard treatment alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 46 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2021
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Documentation of disease * Histologic documentation: Histologically-proven advanced (metastatic or unresectable primary) pheochromocytoma or paraganglioma * Stage: Advanced (metastatic or unresectable primary) disease * Tumor site: Histologically-proven pheochromocytoma or paraganglioma * Radiographic evaluation: Radiographic evidence of disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 in the 12 months prior to registration * Measurable disease * Lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 1 cm with CT or MRI (or \>= 1.5 cm for lymph nodes). Non-measurable disease includes disease smaller than these dimensions or lesions considered truly non-measurable including: leptomeningeal disease, ascites, pleural or pericardial effusion, lymphangitic involvement of skin or lung * Prior treatment with other somatostatin analog, chemotherapy, radiotherapy (including peptide radionuclide receptor therapy \[PRRT\]), or surgery must be completed \>= 28 days prior to registration. Patients must have recovered from any effects of any major surgery prior to registration * Prior treatment with radiolabeled metaiodobenzylguanidine (MIBG) must be completed \>= 12 weeks prior to registration and lifetime cumulative 131I-MIBG dose must be \< 1000 MBq kg\^-1 (36 mCi kg\^-1) * Prior treatment with antibiotics must be completed \>= 7 days prior to registration * No prior treatment with temozolomide, dacarbazine, or a poly ADP ribose polymerase (PARP) inhibitor * No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUCBT) * Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 7 days prior to registration is required * Contraception * Therapy utilized in this trial is associated with medium/high fetal risk * Women of childbearing potential and their partners, who are sexually active, must agree to use two highly effective forms of contraception in combination. This should be started from the time of registration and continue throughout the period of taking study treatment and for at least 1 month after last dose of study drug(s), or they must totally/truly abstain from any form of sexual intercourse * Male patients must use a condom during treatment and for 3 months after the last dose of study drug(s) when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential. Male patients should not donate sperm throughout the period of taking study drug(s) and for 3 months following the last dose of study drug(s) * Age \>= 12 years * Eastern Cooperative Oncology Group (ECOG) Patients ≥ 18 years of age: Performance status: 0-2 * Patients \< 16 years of age: Lansky ≥ 50% * Patients 16 to \< 18 years of age: Karnofsky ≥ 50% * Patients ≥ 18 years of age: ECOG performance status ≤ 2 * Absolute neutrophil count \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Hemoglobin \>= 10 mg/dL if prior radionuclide therapy Hemoglobin \>= 8 mg/dL if no prior radionuclide therapy * In the absence of transfusion within the previous 24 hours. Radionuclide therapy includes PRRT or MIBG * Total bilirubin =\< 1.5 x upper limit of normal (ULN) * Except in the case of Gilbert's syndrome, then total bilirubin must be =\< 3.0 x ULN * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3.0 x ULN * Creatinine \< 1.5 x ULN OR calculated (calc.) creatinine clearance \> 50 mL/min * Calculated by Cockcroft-Gault equation * By Cockcroft-Gault equation. Alternatively, for patients \< 18 years of age, maximum serum creatinine ≤ the below age-sex-specific norms: * Age 12 years: Male 1.2; female 1.2 * Age 13 to \< 16 years: Male 1.5; female 1.4 * Age 16 to \< 18 years: Male 1.7; female 1.4 * No indication of uncontrolled, potentially reversible cardiac condition(s) as determined by investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, Fridericia's formula-corrected QT interval \[QTcF\] prolongation \> 500 msec, electrolyte disturbances, etc.) and no known congenital long QT syndrome * No extensive bilateral lung disease or pneumonitis * No abnormal organ or bone marrow function =\< 28 days prior to registration * Patients with human immunodeficiency virus (HIV) positivity are allowed if CD4 count \> 250 cells/uL and they have an undetectable HIV viral load within 6 months of registration * No active infection * No history of myelodysplastic syndrome (MDS) (or any dysplastic leukocyte morphology suggestive of MDS) or acute myeloid leukemia * No known gastrointestinal condition(s) that might predispose for drug intolerability or poor drug absorption * No known medical condition causing an inability to swallow oral formulations of agents * No history of allergic reaction attributed to compounds of similar chemical or biologic composition to PARP inhibitors * Concurrent use of combination antiretroviral therapy (ART) is not permitted * Chronic concomitant treatment with strong or moderate CYP3A4 inducers or inhibitors is not allowed. Patients must discontinue the agent(s) \>= 21 days prior to registration; enzalutamide and/or phenobarbital must be discontinued \>= 5 weeks prior to registration
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
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Advanced Breast Care Center PLLC
Warren, Michigan, 48088, United States
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Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508, United States
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Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508, United States
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Alaska Women's Cancer Care
Anchorage, Alaska, 99508, United States
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Albany Medical Center
Albany, New York, 12208, United States
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Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508, United States
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Anchorage Oncology Centre
Anchorage, Alaska, 99508, United States
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Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504, United States
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Bay Area Hospital
Coos Bay, Oregon, 97420, United States
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Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan, 48312, United States
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Cambridge Medical Center
Cambridge, Minnesota, 55008, United States
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Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
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Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
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Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
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Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, 73505, United States
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Cancer Hematology Centers - Flint
Flint, Michigan, 48503, United States
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Carle Cancer Center
Urbana, Illinois, 61801, United States
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Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
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Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
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Carle at The Riverfront
Danville, Illinois, 61832, United States
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Caro Cancer Center
Caro, Michigan, 48723, United States
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Centralia Oncology Clinic
Centralia, Illinois, 62801, United States
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Chelsea Hospital
Chelsea, Michigan, 48118, United States
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Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015, United States
-
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
-
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
-
Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts, 02467, United States
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Dell Children's Medical Center of Central Texas
Austin, Texas, 78723, United States
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Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369, United States
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Fairview Lakes Medical Center
Wyoming, Minnesota, 55092, United States
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Fairview Northland Medical Center
Princeton, Minnesota, 55371, United States
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Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
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Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
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Farmington Health Center
Farmington, Utah, 84025, United States
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Genesee Hematology Oncology PC
Flint, Michigan, 48503, United States
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Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
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Health Partners Inc
Minneapolis, Minnesota, 55454, United States
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Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346, United States
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Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
-
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236, United States
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Henry Ford Health Warren Hospital
Warren, Michigan, 48093, United States
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Henry Ford Madison Heights Hospital - Breast
Warren, Michigan, 48093, United States
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Henry Ford River District Hospital
East China Township, Michigan, 48054, United States
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Henry Ford Rochester Hospital
Rochester Hills, Michigan, 48309, United States
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Henry Ford Saint John Hospital - Academic
Grosse Pointe Woods, Michigan, 48236, United States
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Henry Ford Saint John Hospital - Breast
Grosse Pointe Woods, Michigan, 48236, United States
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Henry Ford Saint John Hospital - Macomb Medical
Macomb, Michigan, 48044, United States
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Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods, Michigan, 48236, United States
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Henry Ford Warren Hospital - Breast Macomb
Macomb, Michigan, 48044, United States
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Henry Ford Warren Hospital - GLCMS
Warren, Michigan, 48093, United States
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Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
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Hope Cancer Center
Pontiac, Michigan, 48341, United States
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Hope Cancer Clinic
Livonia, Michigan, 48154, United States
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Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
-
Hurley Medical Center
Flint, Michigan, 48503, United States
-
Huron Gastroenterology PC
Ypsilanti, Michigan, 48106, United States
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Illinois CancerCare - Washington
Washington, Illinois, 61571, United States
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Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
-
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
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Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
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Illinois CancerCare-Dixon
Dixon, Illinois, 61021, United States
-
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
-
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
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Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
-
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
-
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
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Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
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Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
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Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
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Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
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Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336, United States
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Katmai Oncology Group
Anchorage, Alaska, 99508, United States
-
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
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Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017, United States
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Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103, United States
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Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, 18201, United States
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Macomb Hematology Oncology PC
Warren, Michigan, 48093, United States
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
-
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
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Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
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Michigan Healthcare Professionals Pontiac
Pontiac, Michigan, 48341, United States
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Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337, United States
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Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
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Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
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Monticello Cancer Center
Monticello, Minnesota, 55362, United States
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MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601, United States
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MyMichigan Medical Center Tawas
Tawas City, Michigan, 48764, United States
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
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Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346, United States
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Newland Medical Associates-Pontiac
Pontiac, Michigan, 48341, United States
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North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, 48604, United States
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Oregon Health and Science University
Portland, Oregon, 97239, United States
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Pacific Gynecology Specialists
Seattle, Washington, 98104, United States
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Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
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PeaceHealth Saint John Medical Center
Longview, Washington, 98632, United States
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PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225, United States
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PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664, United States
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PeaceHealth United General Medical Center
Sedro-Woolley, Washington, 98284, United States
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Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301, United States
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Providence Alaska Medical Center
Anchorage, Alaska, 99508, United States
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Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015, United States
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Providence Newberg Medical Center
Newberg, Oregon, 97132, United States
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Providence Portland Medical Center
Portland, Oregon, 97213, United States
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Providence Regional Cancer Partnership
Everett, Washington, 98201, United States
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Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520, United States
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Providence Regional Cancer System-Centralia
Centralia, Washington, 98531, United States
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Providence Regional Cancer System-Lacey
Lacey, Washington, 98503, United States
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Providence Regional Cancer System-Shelton
Shelton, Washington, 98584, United States
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Providence Regional Cancer System-Yelm
Yelm, Washington, 98597, United States
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Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505, United States
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Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, 99362, United States
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Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
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Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045, United States
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Regions Hospital
Saint Paul, Minnesota, 55101, United States
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Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
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Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
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Saint Charles Health System
Bend, Oregon, 97701, United States
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Saint Charles Health System-Redmond
Redmond, Oregon, 97756, United States
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Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
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Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
-
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
-
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712, United States
-
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619, United States
-
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642, United States
-
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687, United States
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Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301, United States
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Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan, 48453, United States
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Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, 48661, United States
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Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
-
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026, United States
-
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029, United States
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Swedish Medical Center-Ballard Campus
Seattle, Washington, 98107, United States
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Swedish Medical Center-Cherry Hill
Seattle, Washington, 98122-5711, United States
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Swedish Medical Center-First Hill
Seattle, Washington, 98122, United States
-
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114, United States
-
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188, United States
-
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118, United States
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Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197, United States
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Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114, United States
-
Trinity Health Medical Center - Canton
Canton, Michigan, 48188, United States
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Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
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Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341, United States
-
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
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UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451, United States
-
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610, United States
-
United Hospital
Saint Paul, Minnesota, 55102, United States
-
Unity Hospital
Fridley, Minnesota, 55432, United States
-
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
-
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462, United States
-
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912, United States
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
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University of Utah Sugarhouse Health Center
Salt Lake City, Utah, 84106, United States
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University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
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