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NCT06532279RecruitingPhase 2

Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer

A Randomized, Masked, Placebo Controlled, Phase II Trial Of Concurrent Chemoradiation With BMX-001 In Patients With Head And Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation

Source: ClinicalTrials.gov · Last updated 17 Aug 2026

Brief summary (registry, in English)

This phase II trial compares the effectiveness of adding BMX-001 to usual symptom management versus usual symptom management alone for reducing oral mucositis in patients who are receiving chemoradiation for head and neck cancer. Oral mucositis (inflammation and mouth sores) is a common side effect of chemoradiation that can cause pain and difficulty swallowing. Usual management of these side effects typically consists of using mouth rinses and pain medications during treatment and for several weeks after completion of treatment. BMX-001 neutralizes harmful substances in the body, preventing damage to macromolecules such as DNA and minimizes free radical-related toxicity in normal tissues. Adding BMX-001 to usual symptom management may be more effective than usual symptom management alone at reducing oral mucositis in patients receiving chemoradiation for head and neck cancer.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
98 (estimated)
First submitted
29 Jul 2024
Start date
23 Jun 2025
Primary completion date
1 Jan 2027
Lead sponsor
NRG Oncology
NCT number
NCT06532279

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 98
  • From 23 Jun 2025 to the primary completion date, 1 Jan 2027
  • 153 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

  • Patients must be planned to receive radiation and concurrent cisplatin chemotherapy as definitive therapy. Patients planned to receive concurrent cisplatin and radiation therapy in the adjuvant setting are not eligible.
  • At least two subsites (buccal mucosa, lips, retromolar trigone, floor of mouth, oral tongue, tonsil, soft palate, or hard palate) must have at least 1cc or 1% of the subsite volume receiving \>= 50 Gy. In cases of uncertainty, the enrolling clinician can ensure coverage by inspecting the 50 Gy isodose line and using the table describing the anatomic boundaries of the individual subsites contained within the extended cavity contour. The two or more subsites receiving \>= 50 Gy must be documented by the enrolling physician.
  • Pathologically confirmed (histologically or cytologically) squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity.
  • P16 and/or human papillomavirus (HPV) status (via polymerase chain reaction \[PCR\] or in situ hybridization \[ISH\]) must be documented for patients with oropharynx cancer.
  • No patients with T0/Tx/unknown primary disease.
  • No definitive clinical or radiologic evidence of metastatic (M1) disease related to current diagnosis.
  • Able to receive intensity-modulated radiation therapy (IMRT) delivered as daily fractions of 2.0 Gy once per weekday with a cumulative radiation dose of 70 Gy.
  • Age \>= 18.
  • Zubrod performance status of 0-2.
  • Potassium ≥ institutional lower limit of normal (LLN) and magnesium ≥ institutional LLN. Oral or intravenous (IV) replacement therapy of potassium or magnesium is permitted if parameters can be met after repletion.
  • Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3.
  • Platelets \>= 100,000 cells/mm\^3.
  • Hemoglobin \>= 9.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 10.0 g/dl is acceptable).
  • Adequate renal function defined as creatinine clearance (CrCL) \> 50 mL/min by the Cockcroft-Gault formula.
  • Total bilirubin =\< 2 x institutional upper limit of normal (ULN) (not applicable to patients with known Gilbert's syndrome).
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x institutional ULN.
  • No prior radiotherapy that would result in overlap of radiation treatment fields with planned treatment for study cancer, e.g., breast cancer with irradiation of the supraclavicular fossa/level 4 neck.
  • No concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure.
  • No prior history of gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed.
  • No current treatment of adjuvant post-operative (op) chemoradiation.
  • No systemic treatment with inducers or strong inhibitors of cytochrome P450 =\< 4 days before registration. Note: Patients undergoing steroid treatment as a component of the anti-emetic regimen for cisplatin are eligible for the study. Treatment with the antifungal medications, nystatin, fluconazole , miconazole and clotrimazole are allowed.
  • No prior induction chemotherapy treatment.
  • No prior unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ, basal cell skin carcinoma, resected T1-2N0M0 differentiated thyroid cancers, Ta bladder cancers, or low risk prostate cancer.
  • No clinically significant hearing impairment that precludes cisplatin, as per physician assessment.
  • No serious cardiovascular disease or cerebrovascular disease in the last 6 months prior to study enrollment; defined as a cerebrovascular accident, myocardial infarction, unstable angina, serious cardiac arrhythmia uncontrolled by medication or with the potential to interfere with protocol treatment, or current New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), or admission within last 6 months for CHF exacerbation; (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification).
  • No valvular heart disease.
  • No significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to enrollment.
  • No history or evidence upon physical/neurological examination of central nervous system disease (e.g., seizures) unrelated to cancer unless adequately controlled by medication.
  • No acute bacterial, viral, or fungal infection requiring intravenous antimicrobials within 7 days of enrollment.
  • No history of chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration.
  • No known personal or family history of long QT Syndrome; no marked baseline prolongation of QT/corrected QT (QTc) interval (i.e., ≥ 2 electrocardiograms \[EKGs\] in prior 3 months of a QTc interval \> 450 milliseconds (ms) for males and \> 470 ms for females using the specific/usual choice by clinical center for correction factor.
  • Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities must be reversible to ≤ grade 1 with supplementation.
  • No poorly controlled hypertension (systolic blood pressure \[SBP\] \> 160 and/or diastolic blood pressure \[DBP\] \> 95) over 2 repeated measures within 30 days prior to registration.
  • No grade \>= 2 oral mucositis per CTCAE version 5.0.
  • No grade \>= 2 hypotension per CTCAE v. 5.0.
  • No medical necessity for anti-arrhythmics with significant risk of QTc prolongation such as class I and class III anti-arrhythmics. These include but are not limited to amiodarone, quinidine, dofetilide, sotalol, flecainide, and lidocaine.
  • No medical necessity for medications listed as prohibited.
    • For standard management of oral mucositis, clinicians may consult the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy. The only intervention against mucositis that is supported by level I evidence is low-level laser therapy (LLLT). Honey is rated at level II and benzydamine, which isn't available in the United States (US), is rated at level III. There are no other positively rated interventions.
    • LLLT is prohibited in this study as its availability remains limited, it is not Food and Drug Administration (FDA) approved in the US, and it is considered investigational in many circumstances requiring enrollment in a dedicated protocol who requirements could conflict with this one. Therefore, institutions that use LLLT should only enroll patients who would not be eligible for (or do not want) that intervention. Honey is not on the list of prohibited medications for this study. Given the MASCC recommendation, benzydamine is allowed, although there is lack of availability in the United States of America (USA). The other listed prohibited medications are not recommended by MASCC and some are potentially harmful, such as glutamine, which is associated with mortality in patients receiving stem cell transplant.
  • No history of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).
  • Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (153)

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

SiteCityCountrySite status
Summa Health System - Akron Campus
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AkronUnited StatesRecruiting
Atrium Health Stanly/LCI-Albemarle
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AlbemarleUnited StatesRecruiting
University of New Mexico Cancer Center
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AlbuquerqueUnited StatesRecruiting
McFarland Clinic - Ames
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AmesUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
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AnkenyUnited StatesRecruiting
Langlade Hospital and Cancer Center
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AntigoUnited StatesRecruiting
Northwest Wisconsin Cancer Center
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AshlandUnited StatesRecruiting
Greater Baltimore Medical Center
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BaltimoreUnited StatesRecruiting
McLaren Cancer Institute-Bay City
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Bay CityUnited StatesRecruiting
OSF Saint Joseph Medical Center
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BloomingtonUnited StatesRecruiting
Illinois CancerCare-Bloomington
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BloomingtonUnited StatesRecruiting
Boston Medical Center
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BostonUnited StatesRecruiting
Keck Medicine of USC Buena Park
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Buena ParkUnited StatesSuspended
Illinois CancerCare-Canton
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CantonUnited StatesRecruiting
Aultman Health Foundation
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CantonUnited StatesRecruiting
Saint Francis Medical Center
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Cape GirardeauUnited StatesRecruiting
Mercy Hospital
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Cedar RapidsUnited StatesRecruiting
Oncology Associates at Mercy Medical Center
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Cedar RapidsUnited StatesRecruiting
Chambersburg Hospital
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ChambersburgUnited StatesRecruiting
Atrium Health University City/LCI-University
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CharlotteUnited StatesRecruiting
Atrium Health Pineville/LCI-Pineville
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CharlotteUnited StatesRecruiting
Carolinas Medical Center/Levine Cancer Institute
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CharlotteUnited StatesRecruiting
Northwestern University
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ChicagoUnited StatesRecruiting
University of Cincinnati Cancer Center-UC Medical Center
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CincinnatiUnited StatesRecruiting
McLaren Cancer Institute-Clarkston
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ClarkstonUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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CliveUnited StatesRecruiting
Baptist Memorial Hospital and Cancer Center-Collierville
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ColliervilleUnited StatesRecruiting
Ohio State University Comprehensive Cancer Center
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ColumbusUnited StatesRecruiting
Baptist Memorial Hospital and Cancer Center-Golden Triangle
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ColumbusUnited StatesRecruiting
Atrium Health Cabarrus/LCI-Concord
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ConcordUnited StatesRecruiting
Carle at The Riverfront
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DanvilleUnited StatesRecruiting
Northwestern Medicine Cancer Center Kishwaukee
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DeKalbUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
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Des MoinesUnited StatesRecruiting
Iowa Methodist Medical Center
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Des MoinesUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des MoinesUnited StatesRecruiting
Mercy Medical Center - Des Moines
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Des MoinesUnited StatesRecruiting
Wayne State University/Karmanos Cancer Institute
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DetroitUnited StatesRecruiting
Miller-Dwan Hospital
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DuluthUnited StatesRecruiting
Duke University Medical Center
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DurhamUnited StatesRecruiting
Shaw Cancer Center
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EdwardsUnited StatesRecruiting
Carle Physician Group-Effingham
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EffinghamUnited StatesRecruiting
Baptist Health Hardin
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ElizabethtownUnited StatesRecruiting
UC San Diego Health System - Encinitas
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EncinitasUnited StatesRecruiting
Ephrata Cancer Center
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EphrataUnited StatesRecruiting
UPMC Hillman Cancer Center Erie
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ErieUnited StatesRecruiting
Illinois CancerCare-Eureka
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EurekaUnited StatesRecruiting
Weisberg Cancer Treatment Center
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Farmington HillsUnited StatesRecruiting
UPMC Cancer Center at UPMC Horizon
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FarrellUnited StatesRecruiting
McLaren Cancer Institute-Flint
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FlintUnited StatesRecruiting
Illinois CancerCare-Galesburg
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GalesburgUnited StatesRecruiting
Levine Cancer Institute-Gaston
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GastoniaUnited StatesRecruiting
CaroMont Regional Medical Center
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GastoniaUnited StatesRecruiting
Northwestern Medicine Cancer Center Delnor
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GenevaUnited StatesRecruiting
Adams Cancer Center
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GettysburgUnited StatesRecruiting
Arizona Center for Cancer Care - Gilbert
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GilbertUnited StatesRecruiting
UPMC Cancer Centers - Arnold Palmer Pavilion
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GreensburgUnited StatesRecruiting
Baptist Cancer Center-Grenada
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GrenadaUnited StatesRecruiting
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
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HarrisburgUnited StatesRecruiting
Penn State Milton S. Hershey Medical Center
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HersheyUnited StatesRecruiting
Hayworth Cancer Center
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High PointUnited StatesRecruiting
University of Iowa/Holden Comprehensive Cancer Center
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Iowa CityUnited StatesRecruiting
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
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JonesboroUnited StatesRecruiting
University of Kansas Cancer Center
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Kansas CityUnited StatesRecruiting
Illinois CancerCare-Kewanee Clinic
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KewaneeUnited StatesRecruiting
University of Tennessee - Knoxville
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KnoxvilleUnited StatesRecruiting
UC San Diego Moores Cancer Center
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La JollaUnited StatesRecruiting
Lancaster Radiation Therapy Center
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LancasterUnited StatesRecruiting
Karmanos Cancer Institute at McLaren Greater Lansing
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LansingUnited StatesRecruiting
McLaren Cancer Institute-Lapeer Region
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LapeerUnited StatesRecruiting
Sechler Family Cancer Center
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LebanonUnited StatesRecruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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LebanonUnited StatesRecruiting
Los Angeles General Medical Center
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Los AngelesUnited StatesSuspended
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesSuspended
Illinois CancerCare-Macomb
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MacombUnited StatesRecruiting
Carle Physician Group-Mattoon/Charleston
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MattoonUnited StatesRecruiting
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
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MechanicsburgUnited StatesRecruiting
Baptist Memorial Hospital and Cancer Center-Memphis
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MemphisUnited StatesRecruiting
Froedtert Menomonee Falls Hospital
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Menomonee FallsUnited StatesRecruiting
Medical College of Wisconsin
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MilwaukeeUnited StatesRecruiting
Zablocki Veterans Administration Medical Center
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MilwaukeeUnited StatesRecruiting
Atrium Health Union/LCI-Union
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MonroeUnited StatesRecruiting
UPMC Hillman Cancer Center - Monroeville
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MonroevilleUnited StatesRecruiting
UPMC Cancer Center - Monroeville
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MonroevilleUnited StatesRecruiting
McLaren Cancer Institute-Macomb
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Mount ClemensUnited StatesRecruiting
McLaren Cancer Institute-Central Michigan
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Mount PleasantUnited StatesRecruiting
ProHealth D N Greenwald Center
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MukwonagoUnited StatesActive, not recruiting
Baptist Memorial Hospital and Cancer Center-Union County
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New AlbanyUnited StatesRecruiting
Baptist Health Floyd
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New AlbanyUnited StatesRecruiting
UPMC Hillman Cancer Center - New Castle
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New CastleUnited StatesRecruiting
USC Norris Oncology/Hematology-Newport Beach
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Newport BeachUnited StatesSuspended
Sarasota Memorial Hospital-Venice
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N. VeniceUnited StatesRecruiting
Northwestern Medicine Oak Brook
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Oak BrookUnited StatesRecruiting
Drexel Town Square Health Center
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Oak CreekUnited StatesRecruiting
ProHealth Oconomowoc Memorial Hospital
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OconomowocUnited StatesActive, not recruiting
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesRecruiting
Northwestern Medicine Orland Park
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Orland ParkUnited StatesRecruiting
Lake Regional Hospital
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Osage BeachUnited StatesRecruiting
Illinois CancerCare-Ottawa Clinic
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OttawaUnited StatesRecruiting
Baptist Memorial Hospital and Cancer Center-Oxford
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OxfordUnited StatesRecruiting
Illinois CancerCare-Pekin
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PekinUnited StatesRecruiting
Arizona Center for Cancer Care-Peoria
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PeoriaUnited StatesRecruiting
Illinois CancerCare-Peoria
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PeoriaUnited StatesRecruiting
OSF Saint Francis Medical Center
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PeoriaUnited StatesRecruiting
Illinois CancerCare-Peru
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PeruUnited StatesRecruiting
McLaren Cancer Institute-Northern Michigan
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PetoskeyUnited StatesRecruiting
Arizona Center for Cancer Care - Phoenix
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PhoenixUnited StatesRecruiting
UPMC-Saint Margaret
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PittsburghUnited StatesRecruiting
UPMC-Shadyside Hospital
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PittsburghUnited StatesRecruiting
UPMC-Passavant Hospital
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PittsburghUnited StatesRecruiting
University of Pittsburgh Cancer Institute (UPCI)
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PittsburghUnited StatesRecruiting
UPMC-Saint Clair Hospital Cancer Center
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PittsburghUnited StatesRecruiting
McLaren-Port Huron
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Port HuronUnited StatesRecruiting
Illinois CancerCare-Princeton
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PrincetonUnited StatesRecruiting
Renown Regional Medical Center
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RenoUnited StatesRecruiting
Aspirus Cancer Care - James Beck Cancer Center
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RhinelanderUnited StatesRecruiting
VCU Massey Cancer Center at Stony Point
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RichmondUnited StatesRecruiting
VCU Massey Comprehensive Cancer Center
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RichmondUnited StatesRecruiting
Levine Cancer Institute-Rock Hill
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Rock HillUnited StatesRecruiting
Rock Hill Radiation Therapy Center
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Rock HillUnited StatesRecruiting
Moffitt Cancer Center at SouthShore
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RuskinUnited StatesRecruiting
Dartmouth Cancer Center - North
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Saint JohnsburyUnited StatesRecruiting
Salina Regional Health Center
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SalinaUnited StatesRecruiting
UC San Diego Medical Center - Hillcrest
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San DiegoUnited StatesRecruiting
Sarasota Memorial Hospital
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SarasotaUnited StatesRecruiting
Florida Cancer Specialists - Sarasota Downtown
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SarasotaUnited StatesRecruiting
Sarasota Memorial Health Care Center at University Parkway
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SarasotaUnited StatesRecruiting
Florida Cancer Specialists - Sarasota
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SarasotaUnited StatesRecruiting
Arizona Center for Cancer Care - Scottsdale
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ScottsdaleUnited StatesRecruiting
Atrium Health Cleveland/LCI-Cleveland
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ShelbyUnited StatesRecruiting
Baptist Memorial Hospital and Cancer Center-Desoto
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SouthhavenUnited StatesRecruiting
Aspirus Cancer Care - Stevens Point
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Stevens PointUnited StatesRecruiting
Arizona Center for Cancer Care-Surprise
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SurpriseUnited StatesRecruiting
Moffitt Cancer Center - McKinley Campus
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TampaUnited StatesRecruiting
Moffitt Cancer Center-International Plaza
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TampaUnited StatesRecruiting
Moffitt Cancer Center
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TampaUnited StatesRecruiting
Arizona Center for Cancer Care
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TempeUnited StatesRecruiting
Montefiore Medical Center - Moses Campus
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The BronxUnited StatesRecruiting
Montefiore Medical Center-Einstein Campus
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The BronxUnited StatesRecruiting
Carle Cancer Center
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UrbanaUnited StatesRecruiting
Florida Cancer Specialists - Venice Pinebrook
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VeniceUnited StatesRecruiting
Northwestern Medicine Cancer Center Warrenville
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WarrenvilleUnited StatesRecruiting
Illinois CancerCare - Washington
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WashingtonUnited StatesRecruiting
George Washington University Medical Center
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Washington D.C.United StatesRecruiting
UI Health Care Mission Cancer and Blood - Waukee Clinic
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WaukeeUnited StatesRecruiting
UW Cancer Center at ProHealth Care
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WaukeshaUnited StatesActive, not recruiting
Aspirus Regional Cancer Center
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WausauUnited StatesRecruiting
Moffitt Cancer Center at Wesley Chapel
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Wesley ChapelUnited StatesRecruiting
Froedtert West Bend Hospital/Kraemer Cancer Center
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West BendUnited StatesRecruiting
University of Cincinnati Cancer Center-West Chester
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West ChesterUnited StatesRecruiting
University of Kansas Hospital-Westwood Cancer Center
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WestwoodUnited StatesRecruiting
Wake Forest University Health Sciences
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Winston-SalemUnited StatesRecruiting
Aspirus Cancer Care - Wisconsin Rapids
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Wisconsin RapidsUnited StatesRecruiting
WellSpan Health-York Cancer Center
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YorkUnited StatesRecruiting

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