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NCT04394858Active, not recruitingPhase 2

Testing the Addition of an Anticancer Drug, Olaparib, to the Usual Chemotherapy (Temozolomide) for Advanced Neuroendocrine Cancer

A Prospective, Multi-Institutional Phase II Trial Evaluating Temozolomide vs. Temozolomide and Olaparib for Advanced Pheochromocytoma and Paraganglioma

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

This phase II trial studies how well the addition of olaparib to the usual treatment, temozolomide, works in treating patients with neuroendocrine cancer (pheochromocytoma or paraganglioma) that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Poly (adenosine diphosphate \[ADP\]-ribose) polymerases (PARPs) are proteins that help repair deoxyribonucleic acid (DNA) mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving olaparib with temozolomide may shrink or stabilize the cancer in patients with pheochromocytoma or paraganglioma better than temozolomide alone.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
46 (estimated)
First submitted
19 May 2020
Start date
17 Mar 2021
Primary completion date
1 Mar 2028
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT04394858

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 46
  • From 17 Mar 2021 to the primary completion date, 1 Mar 2028
  • 163 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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

Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (163)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Providence Regional Cancer System-Aberdeen
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AberdeenUnited StatesUnknown status
Albany Medical Center
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AlbanyUnited StatesUnknown status
Lehigh Valley Hospital-Cedar Crest
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AllentownUnited StatesUnknown status
Alaska Breast Care and Surgery LLC
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AnchorageUnited StatesUnknown status
Anchorage Radiation Therapy Center
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AnchorageUnited StatesUnknown status
Providence Alaska Medical Center
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AnchorageUnited StatesUnknown status
Anchorage Oncology Centre
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AnchorageUnited StatesUnknown status
Alaska Oncology and Hematology LLC
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AnchorageUnited StatesUnknown status
Anchorage Associates in Radiation Medicine
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AnchorageUnited StatesUnknown status
Katmai Oncology Group
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AnchorageUnited StatesUnknown status
Alaska Women's Cancer Care
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AnchorageUnited StatesUnknown status
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Ann ArborUnited StatesUnknown status
Dell Children's Medical Center of Central Texas
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AustinUnited StatesUnknown status
Memorial Sloan Kettering Basking Ridge
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Basking RidgeUnited StatesUnknown status
PeaceHealth Saint Joseph Medical Center
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BellinghamUnited StatesUnknown status
Saint Charles Health System
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BendUnited StatesUnknown status
National Institutes of Health Clinical Center
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BethesdaUnited StatesUnknown status
Lehigh Valley Hospital - Muhlenberg
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BethlehemUnited StatesUnknown status
Illinois CancerCare-Bloomington
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BloomingtonUnited StatesUnknown status
Saint Luke's Cancer Institute - Boise
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BoiseUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
Trinity Health IHA Medical Group Hematology Oncology - Brighton
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BrightonUnited StatesUnknown status
Trinity Health Medical Center - Brighton
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BrightonUnited StatesUnknown status
Providence Saint Joseph Medical Center/Disney Family Cancer Center
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BurbankUnited StatesUnknown status
Fairview Ridges Hospital
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BurnsvilleUnited StatesUnknown status
Minnesota Oncology - Burnsville
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BurnsvilleUnited StatesUnknown status
Cambridge Medical Center
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CambridgeUnited StatesUnknown status
Trinity Health Medical Center - Canton
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CantonUnited StatesUnknown status
Trinity Health IHA Medical Group Hematology Oncology - Canton
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CantonUnited StatesUnknown status
Illinois CancerCare-Canton
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CantonUnited StatesUnknown status
Saint Francis Medical Center
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Cape GirardeauUnited StatesUnknown status
Caro Cancer Center
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CaroUnited StatesUnknown status
Illinois CancerCare-Carthage
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CarthageUnited StatesUnknown status
Providence Regional Cancer System-Centralia
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CentraliaUnited StatesUnknown status
Centralia Oncology Clinic
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CentraliaUnited StatesUnknown status
University of Virginia Cancer Center
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CharlottesvilleUnited StatesUnknown status
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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ChelseaUnited StatesUnknown status
Chelsea Hospital
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ChelseaUnited StatesUnknown status
University of Chicago Comprehensive Cancer Center
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ChicagoUnited StatesUnknown status
Providence Cancer Institute Clackamas Clinic
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ClackamasUnited StatesUnknown status
Clackamas Radiation Oncology Center
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ClackamasUnited StatesUnknown status
Hematology Oncology Consultants-Clarkston
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ClarkstonUnited StatesUnknown status
Newland Medical Associates-Clarkston
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ClarkstonUnited StatesUnknown status
Ohio State University Comprehensive Cancer Center
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ColumbusUnited StatesUnknown status
Memorial Sloan Kettering Commack
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CommackUnited StatesUnknown status
Mercy Hospital
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Coon RapidsUnited StatesUnknown status
Bay Area Hospital
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Coos BayUnited StatesUnknown status
Carle at The Riverfront
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DanvilleUnited StatesUnknown status
Cancer Care Specialists of Illinois - Decatur
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DecaturUnited StatesUnknown status
Henry Ford Health Saint John Hospital
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DetroitUnited StatesUnknown status
Illinois CancerCare-Dixon
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DixonUnited StatesUnknown status
Henry Ford River District Hospital
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East China TownshipUnited StatesUnknown status
Pocono Medical Center
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East StroudsburgUnited StatesUnknown status
Fairview Southdale Hospital
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EdinaUnited StatesUnknown status
Swedish Cancer Institute-Edmonds
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EdmondsUnited StatesUnknown status
Carle Physician Group-Effingham
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EffinghamUnited StatesUnknown status
Crossroads Cancer Center
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EffinghamUnited StatesUnknown status
Illinois CancerCare-Eureka
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EurekaUnited StatesUnknown status
Providence Regional Cancer Partnership
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EverettUnited StatesUnknown status
Farmington Health Center
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FarmingtonUnited StatesUnknown status
Genesys Hurley Cancer Institute
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FlintUnited StatesUnknown status
Genesee Hematology Oncology PC
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FlintUnited StatesUnknown status
Hurley Medical Center
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FlintUnited StatesUnknown status
Cancer Hematology Centers - Flint
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FlintUnited StatesUnknown status
Holy Cross Hospital
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Fort LauderdaleUnited StatesUnknown status
Unity Hospital
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FridleyUnited StatesUnknown status
Saint Luke's Cancer Institute - Fruitland
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FruitlandUnited StatesUnknown status
UF Health Cancer Institute - Gainesville
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GainesvilleUnited StatesUnknown status
Illinois CancerCare-Galesburg
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GalesburgUnited StatesUnknown status
Henry Ford Saint John Hospital - Breast
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Grosse Pointe WoodsUnited StatesUnknown status
Henry Ford Saint John Hospital - Academic
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Grosse Pointe WoodsUnited StatesUnknown status
Henry Ford Saint John Hospital - Van Elslander
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Grosse Pointe WoodsUnited StatesUnknown status
Memorial Sloan Kettering Westchester
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HarrisonUnited StatesUnknown status
Lehigh Valley Hospital-Hazleton
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HazletonUnited StatesUnknown status
Swedish Cancer Institute-Issaquah
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IssaquahUnited StatesUnknown status
Kadlec Clinic Hematology and Oncology
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KennewickUnited StatesUnknown status
Illinois CancerCare-Kewanee Clinic
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KewaneeUnited StatesUnknown status
Providence Regional Cancer System-Lacey
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LaceyUnited StatesUnknown status
University of Michigan Health - Sparrow Lansing
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LansingUnited StatesUnknown status
Cancer Centers of Southwest Oklahoma Research
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LawtonUnited StatesUnknown status
Hope Cancer Clinic
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LivoniaUnited StatesUnknown status
Trinity Health Saint Mary Mercy Livonia Hospital
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LivoniaUnited StatesUnknown status
PeaceHealth Saint John Medical Center
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LongviewUnited StatesUnknown status
Henry Ford Saint John Hospital - Macomb Medical
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MacombUnited StatesUnknown status
Henry Ford Warren Hospital - Breast Macomb
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MacombUnited StatesUnknown status
Illinois CancerCare-Macomb
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MacombUnited StatesUnknown status
Fairview Clinics and Surgery Center Maple Grove
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Maple GroveUnited StatesUnknown status
Minnesota Oncology Hematology PA-Maplewood
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MaplewoodUnited StatesUnknown status
Saint John's Hospital - Healtheast
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MaplewoodUnited StatesUnknown status
Saint Mary's Oncology/Hematology Associates of Marlette
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MarletteUnited StatesUnknown status
Carle Physician Group-Mattoon/Charleston
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MattoonUnited StatesUnknown status
Saint Luke's Cancer Institute - Meridian
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MeridianUnited StatesUnknown status
Memorial Sloan Kettering Monmouth
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MiddletownUnited StatesUnknown status
Health Partners Inc
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MinneapolisUnited StatesUnknown status
Abbott-Northwestern Hospital
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MinneapolisUnited StatesUnknown status
Hennepin County Medical Center
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MinneapolisUnited StatesUnknown status
Saint Patrick Hospital - Community Hospital
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MissoulaUnited StatesUnknown status
Monticello Cancer Center
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MonticelloUnited StatesUnknown status
Memorial Sloan Kettering Bergen
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MontvaleUnited StatesUnknown status
Saint Luke's Cancer Institute - Nampa
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NampaUnited StatesUnknown status
Providence Newberg Medical Center
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NewbergUnited StatesUnknown status
UC Comprehensive Cancer Center at Silver Cross
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New LenoxUnited StatesUnknown status
Cancer Center of Western Wisconsin
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New RichmondUnited StatesUnknown status
Dana-Farber Cancer Institute - Chestnut Hill
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NewtonUnited StatesUnknown status
New Ulm Medical Center
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New UlmUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Cancer Care Center of O'Fallon
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O'FallonUnited StatesUnknown status
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesUnknown status
Providence Willamette Falls Medical Center
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Oregon CityUnited StatesUnknown status
University of Chicago Medicine-Orland Park
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Orland ParkUnited StatesUnknown status
Illinois CancerCare-Ottawa Clinic
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OttawaUnited StatesUnknown status
Illinois CancerCare-Pekin
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PekinUnited StatesUnknown status
Illinois CancerCare-Peoria
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PeoriaUnited StatesUnknown status
Illinois CancerCare-Peru
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PeruUnited StatesUnknown status
Hope Cancer Center
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PontiacUnited StatesUnknown status
Michigan Healthcare Professionals Pontiac
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PontiacUnited StatesUnknown status
Trinity Health Saint Joseph Mercy Oakland Hospital
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PontiacUnited StatesUnknown status
Trinity Health IHA Medical Group-Alice Gustafson Center
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PontiacUnited StatesUnknown status
Providence Portland Medical Center
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PortlandUnited StatesUnknown status
Providence Saint Vincent Medical Center
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PortlandUnited StatesUnknown status
Oregon Health and Science University
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PortlandUnited StatesUnknown status
Illinois CancerCare-Princeton
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PrincetonUnited StatesUnknown status
Fairview Northland Medical Center
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PrincetonUnited StatesUnknown status
Saint Charles Health System-Redmond
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RedmondUnited StatesUnknown status
North Memorial Medical Health Center
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RobbinsdaleUnited StatesUnknown status
Mayo Clinic in Rochester
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RochesterUnited StatesUnknown status
Henry Ford Rochester Hospital
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Rochester HillsUnited StatesUnknown status
MyMichigan Medical Center Saginaw
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SaginawUnited StatesUnknown status
Oncology Hematology Associates of Saginaw Valley PC
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SaginawUnited StatesUnknown status
Park Nicollet Clinic - Saint Louis Park
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Saint Louis ParkUnited StatesUnknown status
United Hospital
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Saint PaulUnited StatesUnknown status
Regions Hospital
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Saint PaulUnited StatesUnknown status
University of Utah Sugarhouse Health Center
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Salt Lake CityUnited StatesUnknown status
Huntsman Cancer Institute/University of Utah
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Salt Lake CityUnited StatesUnknown status
Pacific Gynecology Specialists
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SeattleUnited StatesUnknown status
Swedish Medical Center-First Hill
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SeattleUnited StatesUnknown status
Swedish Medical Center-Cherry Hill
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SeattleUnited StatesUnknown status
Swedish Medical Center-Ballard Campus
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SeattleUnited StatesUnknown status
PeaceHealth United General Medical Center
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Sedro-WoolleyUnited StatesUnknown status
Saint Francis Regional Medical Center
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ShakopeeUnited StatesUnknown status
Providence Regional Cancer System-Shelton
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SheltonUnited StatesUnknown status
Bhadresh Nayak MD PC-Sterling Heights
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Sterling HeightsUnited StatesUnknown status
Lakeview Hospital
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StillwaterUnited StatesUnknown status
MyMichigan Medical Center Tawas
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Tawas CityUnited StatesUnknown status
Saint Luke's Cancer Institute - Twin Falls
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Twin FallsUnited StatesUnknown status
Memorial Sloan Kettering Nassau
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UniondaleUnited StatesUnknown status
Carle Cancer Center
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UrbanaUnited StatesUnknown status
PeaceHealth Southwest Medical Center
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VancouverUnited StatesUnknown status
Ridgeview Medical Center
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WaconiaUnited StatesUnknown status
Providence Saint Mary Regional Cancer Center
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Walla WallaUnited StatesUnknown status
Advanced Breast Care Center PLLC
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WarrenUnited StatesUnknown status
Macomb Hematology Oncology PC
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WarrenUnited StatesUnknown status
Henry Ford Health Warren Hospital
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WarrenUnited StatesUnknown status
Henry Ford Madison Heights Hospital - Breast
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WarrenUnited StatesUnknown status
Henry Ford Warren Hospital - GLCMS
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WarrenUnited StatesUnknown status
Illinois CancerCare - Washington
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WashingtonUnited StatesUnknown status
Saint Mary's Oncology/Hematology Associates of West Branch
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West BranchUnited StatesUnknown status
Rice Memorial Hospital
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WillmarUnited StatesUnknown status
Minnesota Oncology Hematology PA-Woodbury
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WoodburyUnited StatesUnknown status
Fairview Lakes Medical Center
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WyomingUnited StatesUnknown status
Providence Regional Cancer System-Yelm
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YelmUnited StatesUnknown status
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
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YpsilantiUnited StatesUnknown status
Huron Gastroenterology PC
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YpsilantiUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.