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

NCT ID: NCT06532279

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-02

Study Completion Date

2027-01-01

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVE:

I. To compare the incidence of severe oral mucositis (SOM) between manganese superoxide dismutase (MnSOD) mimetic BMX-001 (BMX-001) and placebo, defined as \>= grade 3 per World Health Organization (WHO) criteria from the start of radiation through 4 weeks after completion of study treatment, with additional assessments at 6, 8 and 12 weeks after completion of study treatment.

SECONDARY OBJECTIVES:

I. To compare the duration of SOM in the BMX-001 arm versus (vs.) placebo arm. II. To assess the difference between arms in the Oral Mucositis Weekly Questionnaire-Head and Neck (OMWQ-HN) change score from baseline to 4 weeks after the end of chemoradiation.

III. To describe the incidence and severity of xerostomia and radiation dermatitis, as measured by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0, in both arms.

IV. To compare the duration of radiation dermatitis in the BMX-001 arm vs. placebo arm.

V. To describe toxicity, as measured by CTCAE v5.0 and Patient Reported Outcome (PRO)-CTCAE, in both arms.

EXPLORATORY OBJECTIVES:

I. To assess the between arm difference in progression-free survival (PFS). II. To assess the between arm difference in overall survival (OS). III. Data demonstrating improvement in pain, as measured by reduction in narcotic use between BMX-001 versus usual care.

IV. Collect serum and plasma for future translational research analyses.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients receive cisplatin once weekly (QW) or once every 3 weeks (Q3W) and undergo image-guided intensity-modulated radiation therapy once daily (QD) 5 days per week for 7 weeks per standard of care (SOC). In addition to usual symptom management, patients receive placebo subcutaneously (SC) as early as 96 hours and no later than one hour prior to their first dose of radiation therapy, and as early as 96 hours and no later than 48 hours prior to first dose of cisplatin. Patients then receive placebo SC twice a week (BIW) for 8 weeks (16 doses). Patients also undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) on study and may optionally undergo collection of blood, serum, and/or plasma throughout the study.

ARM 2: Patients receive cisplatin QW or Q3W and undergo image-guided intensity-modulated radiation therapy QD 5 days per week for 7 weeks per SOC. In addition to usual symptom management, patients receive BMX-001 SC as early as 96 hours and no later than one hour prior to their first dose of radiation therapy, and as early as 96 hours and no later than 48 hours prior to first dose of cisplatin. Patients then receive BMX-001 SC BIW for 8 weeks (16 doses). Patients also undergo CT and/or MRI on study and may optionally undergo collection of blood, serum, and/or plasma throughout the study.

After completion of study treatment, patients are followed up at 1, 2, 3, 6, 12, and 24 months.

Conditions

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Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Head and Neck Squamous Cell Carcinoma Hypopharyngeal Squamous Cell Carcinoma Laryngeal Squamous Cell Carcinoma Nasopharyngeal Squamous Cell Carcinoma Oral Cavity Squamous Cell Carcinoma Oropharyngeal Squamous Cell Carcinoma Stage 0 Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 Stage 0 Hypopharyngeal Carcinoma AJCC v8 Stage 0 Nasopharyngeal Carcinoma AJCC v8 Stage 0 Oropharyngeal (p16-Negative) Carcinoma AJCC v8 Stage I Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 Stage I Hypopharyngeal Carcinoma AJCC v8 Stage I Laryngeal Cancer AJCC v8 Stage I Lip and Oral Cavity Cancer AJCC v8 Stage I Nasopharyngeal Carcinoma AJCC v8 Stage I Oropharyngeal (p16-Negative) Carcinoma AJCC v8 Stage II Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 Stage II Hypopharyngeal Carcinoma AJCC v8 Stage II Laryngeal Cancer AJCC v8 Stage II Lip and Oral Cavity Cancer AJCC v8 Stage II Nasopharyngeal Carcinoma AJCC v8 Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8 Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 Stage III Hypopharyngeal Carcinoma AJCC v8 Stage III Laryngeal Cancer AJCC v8 Stage III Lip and Oral Cavity Cancer AJCC v8 Stage III Nasopharyngeal Carcinoma AJCC v8 Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8 Stage IVA Hypopharyngeal Carcinoma AJCC v8 Stage IVA Laryngeal Cancer AJCC v8 Stage IVA Lip and Oral Cavity Cancer AJCC v8 Stage IVA Nasopharyngeal Carcinoma AJCC v8 Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8 Stage IVB Hypopharyngeal Carcinoma AJCC v8 Stage IVB Laryngeal Cancer AJCC v8 Stage IVB Lip and Oral Cavity Cancer AJCC v8 Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8 Stomatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double Blind. Fully blinded team members- Refers to individuals that have no access to view preparation of study drug. Study team members who are administering study drug (not preparing) will be included, however individuals that administer study drug should not perform efficacy assessments.

Any investigator or sub-investigator involved in performing efficacy and safety assessments- These individuals should not be involved in preparation of the study drug and should avoid visual access during study drug administration when possible. Where possible, any other site staff member who does not have specific responsibilities that require access to IP (e.g., data entry assistant) should remain fully blinded.

Study Groups

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Arm 1 (placebo)

Patients receive cisplatin QW or Q3W and undergo image-guided intensity-modulated radiation therapy QD 5 days per week for 7 weeks per SOC. In addition to usual symptom management, patients receive placebo SC as early as 96 hours and no later than one hour prior to their first dose of radiation therapy, and as early as 96 hours and no later than 48 hours prior to first dose of cisplatin. Patients then receive placebo SC BIW for 8 weeks (16 doses). Patients also undergo CT and/or MRI on study and may optionally undergo collection of blood, serum, and/or plasma throughout the study.

Group Type PLACEBO_COMPARATOR

Best Practice

Intervention Type OTHER

Receive usual symptom management

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood, serum, and/or plasma samples

Cisplatin

Intervention Type DRUG

Given cisplatin

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Image Guided Radiation Therapy

Intervention Type RADIATION

Undergo image-guided radiation therapy

Intensity-Modulated Radiation Therapy

Intervention Type RADIATION

Undergo intensity-modulated radiation therapy

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Placebo Administration

Intervention Type DRUG

Given SC

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm 2 (BMX-001)

Patients receive cisplatin QW or Q3W and undergo image-guided intensity-modulated radiation therapy QD 5 days per week for 7 weeks per SOC. In addition to usual symptom management, patients receive BMX-001 SC as early as 96 hours and no later than one hour prior to their first dose of radiation therapy, and as early as 96 hours and no later than 48 hours prior to first dose of cisplatin. Patients then receive BMX-001 SC BIW for 8 weeks (16 doses). Patients also undergo CT and/or MRI on study and may optionally undergo collection of blood, serum, and/or plasma throughout the study.

Group Type EXPERIMENTAL

Best Practice

Intervention Type OTHER

Receive usual symptom management

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood, serum, and/or plasma samples

Cisplatin

Intervention Type DRUG

Given cisplatin

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Image Guided Radiation Therapy

Intervention Type RADIATION

Undergo image-guided radiation therapy

Intensity-Modulated Radiation Therapy

Intervention Type RADIATION

Undergo intensity-modulated radiation therapy

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

MnSOD Mimetic BMX-001

Intervention Type DRUG

Given SC

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive usual symptom management

Intervention Type OTHER

Biospecimen Collection

Undergo collection of blood, serum, and/or plasma samples

Intervention Type PROCEDURE

Cisplatin

Given cisplatin

Intervention Type DRUG

Computed Tomography

Undergo CT

Intervention Type PROCEDURE

Image Guided Radiation Therapy

Undergo image-guided radiation therapy

Intervention Type RADIATION

Intensity-Modulated Radiation Therapy

Undergo intensity-modulated radiation therapy

Intervention Type RADIATION

Magnetic Resonance Imaging

Undergo MRI

Intervention Type PROCEDURE

MnSOD Mimetic BMX-001

Given SC

Intervention Type DRUG

Placebo Administration

Given SC

Intervention Type DRUG

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy Biological Sample Collection Biospecimen Collected Specimen Collection Abiplatin Blastolem Briplatin CDDP Cis-diammine-dichloroplatinum Cis-diamminedichloridoplatinum Cis-diamminedichloro Platinum (II) Cis-diamminedichloroplatinum Cis-dichloroammine Platinum (II) Cis-platinous Diamine Dichloride Cis-platinum Cis-platinum II Cis-platinum II Diamine Dichloride Cismaplat Cisplatina Cisplatinum Cisplatyl Citoplatino Citosin Cysplatyna DDP Lederplatin Metaplatin Neoplatin Peyrone's Chloride Peyrone's Salt Placis Plastistil Platamine Platiblastin Platiblastin-S Platinex Platinol Platinol- AQ Platinol-AQ Platinol-AQ VHA Plus Platinoxan Platinum Platinum Diamminodichloride Platiran Platistin Platosin CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography Computerized Tomography (CT) scan CT CT Scan tomography IGRT image-guided radiation therapy Image-Guided Radiotherapy IMRT Intensity modulated radiation therapy (procedure) Intensity Modulated RT Intensity-Modulated Radiotherapy Radiation, Intensity-Modulated Radiotherapy Magnetic Resonance Magnetic Resonance Imaging (MRI) Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan MRIs NMR Imaging NMRI Nuclear Magnetic Resonance Imaging sMRI Structural MRI BMX-001 Manganese (III) ortho N-Butoxyethylpyridylporphyrin Manganese Butoxyethyl Pyridyl Porphyrin Mitochondrial Manganese Superoxide Dismutatse Mimetic BMX-001 Mn(III) meso-tetrakis(N-n-butoxyethylpyridinium-2-yl)porphyrin MnTnBuOE-3-PyP 5+

Eligibility Criteria

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Inclusion Criteria

* 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 and will be reviewed centrally to confirm eligibility.
* 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 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.
* 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 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.
* 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.
* 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 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 https://acsjournals.onlinelibrary.wiley.com/doi/epdf/10.1002/cncr.33100. 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NRG Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David M Brizel

Role: PRINCIPAL_INVESTIGATOR

NRG Oncology

Locations

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Arizona Center for Cancer Care - Gilbert

Gilbert, Arizona, United States

Site Status RECRUITING

Arizona Center for Cancer Care-Peoria

Peoria, Arizona, United States

Site Status RECRUITING

Arizona Center for Cancer Care - Phoenix

Phoenix, Arizona, United States

Site Status RECRUITING

Arizona Center for Cancer Care - Scottsdale

Scottsdale, Arizona, United States

Site Status RECRUITING

Arizona Center for Cancer Care-Surprise

Surprise, Arizona, United States

Site Status RECRUITING

Arizona Center for Cancer Care

Tempe, Arizona, United States

Site Status RECRUITING

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

Site Status RECRUITING

Keck Medicine of USC Buena Park

Buena Park, California, United States

Site Status RECRUITING

Los Angeles General Medical Center

Los Angeles, California, United States

Site Status RECRUITING

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, United States

Site Status RECRUITING

Shaw Cancer Center

Edwards, Colorado, United States

Site Status RECRUITING

George Washington University Medical Center

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Moffitt Cancer Center at SouthShore

Ruskin, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center-International Plaza

Tampa, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, Florida, United States

Site Status RECRUITING

OSF Saint Joseph Medical Center

Bloomington, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Canton

Canton, Illinois, United States

Site Status RECRUITING

Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

Carle at The Riverfront

Danville, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, United States

Site Status RECRUITING

Carle Physician Group-Effingham

Effingham, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Site Status RECRUITING

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Orland Park

Orland Park, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status RECRUITING

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Peru

Peru, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Site Status RECRUITING

Carle Cancer Center

Urbana, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Site Status RECRUITING

Illinois CancerCare - Washington

Washington, Illinois, United States

Site Status RECRUITING

McFarland Clinic - Ames

Ames, Iowa, United States

Site Status RECRUITING

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, United States

Site Status RECRUITING

Mercy Hospital

Cedar Rapids, Iowa, United States

Site Status RECRUITING

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

Site Status RECRUITING

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, United States

Site Status RECRUITING

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Site Status RECRUITING

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, United States

Site Status RECRUITING

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

Site Status RECRUITING

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, United States

Site Status RECRUITING

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Site Status RECRUITING

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, United States

Site Status RECRUITING

University of Kansas Cancer Center

Kansas City, Kansas, United States

Site Status RECRUITING

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

Site Status RECRUITING

Baptist Health Hardin

Elizabethtown, Kentucky, United States

Site Status RECRUITING

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Site Status RECRUITING

McLaren Cancer Institute-Bay City

Bay City, Michigan, United States

Site Status RECRUITING

McLaren Cancer Institute-Clarkston

Clarkston, Michigan, United States

Site Status RECRUITING

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status RECRUITING

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

Site Status RECRUITING

McLaren Cancer Institute-Flint

Flint, Michigan, United States

Site Status RECRUITING

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, United States

Site Status RECRUITING

McLaren Cancer Institute-Lapeer Region

Lapeer, Michigan, United States

Site Status RECRUITING

McLaren Cancer Institute-Macomb

Mount Clemens, Michigan, United States

Site Status RECRUITING

McLaren Cancer Institute-Central Michigan

Mount Pleasant, Michigan, United States

Site Status RECRUITING

McLaren Cancer Institute-Northern Michigan

Petoskey, Michigan, United States

Site Status RECRUITING

McLaren-Port Huron

Port Huron, Michigan, United States

Site Status RECRUITING

Miller-Dwan Hospital

Duluth, Minnesota, United States

Site Status RECRUITING

Baptist Memorial Hospital and Cancer Center-Golden Triangle

Columbus, Mississippi, United States

Site Status RECRUITING

Baptist Cancer Center-Grenada

Grenada, Mississippi, United States

Site Status RECRUITING

Baptist Memorial Hospital and Cancer Center-Union County

New Albany, Mississippi, United States

Site Status RECRUITING

Baptist Memorial Hospital and Cancer Center-Oxford

Oxford, Mississippi, United States

Site Status RECRUITING

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, United States

Site Status RECRUITING

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Site Status RECRUITING

Lake Regional Hospital

Osage Beach, Missouri, United States

Site Status RECRUITING

Renown Regional Medical Center

Reno, Nevada, United States

Site Status RECRUITING

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

Site Status RECRUITING

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status RECRUITING

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Site Status RECRUITING

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Site Status RECRUITING

Atrium Health Stanly/LCI-Albemarle

Albemarle, North Carolina, United States

Site Status RECRUITING

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status RECRUITING

Atrium Health Pineville/LCI-Pineville

Charlotte, North Carolina, United States

Site Status RECRUITING

Atrium Health University City/LCI-University

Charlotte, North Carolina, United States

Site Status RECRUITING

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina, United States

Site Status RECRUITING

Duke University Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

CaroMont Regional Medical Center

Gastonia, North Carolina, United States

Site Status RECRUITING

Levine Cancer Institute-Gaston

Gastonia, North Carolina, United States

Site Status RECRUITING

Hayworth Cancer Center

High Point, North Carolina, United States

Site Status RECRUITING

Atrium Health Union/LCI-Union

Monroe, North Carolina, United States

Site Status RECRUITING

Atrium Health Cleveland/LCI-Cleveland

Shelby, North Carolina, United States

Site Status RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Summa Health System - Akron Campus

Akron, Ohio, United States

Site Status RECRUITING

Aultman Health Foundation

Canton, Ohio, United States

Site Status RECRUITING

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status RECRUITING

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

Site Status RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Chambersburg Hospital

Chambersburg, Pennsylvania, United States

Site Status RECRUITING

Ephrata Cancer Center

Ephrata, Pennsylvania, United States

Site Status RECRUITING

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, United States

Site Status RECRUITING

Adams Cancer Center

Gettysburg, Pennsylvania, United States

Site Status RECRUITING

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, United States

Site Status RECRUITING

Sechler Family Cancer Center

Lebanon, Pennsylvania, United States

Site Status RECRUITING

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, United States

Site Status RECRUITING

UPMC Cancer Center - Monroeville

Monroeville, Pennsylvania, United States

Site Status RECRUITING

UPMC Hillman Cancer Center - Monroeville

Monroeville, Pennsylvania, United States

Site Status RECRUITING

UPMC-Saint Margaret

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

UPMC-Saint Clair Hospital Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

WellSpan Health-York Cancer Center

York, Pennsylvania, United States

Site Status RECRUITING

Lancaster Radiation Therapy Center

Lancaster, South Carolina, United States

Site Status RECRUITING

Rock Hill Radiation Therapy Center

Rock Hill, South Carolina, United States

Site Status RECRUITING

Levine Cancer Institute-Rock Hill

Rock Hill, South Carolina, United States

Site Status RECRUITING

Baptist Memorial Hospital and Cancer Center-Collierville

Collierville, Tennessee, United States

Site Status RECRUITING

University of Tennessee - Knoxville

Knoxville, Tennessee, United States

Site Status RECRUITING

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, United States

Site Status RECRUITING

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, United States

Site Status RECRUITING

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States

Site Status RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

Site Status RECRUITING

Langlade Hospital and Cancer Center

Antigo, Wisconsin, United States

Site Status RECRUITING

Northwest Wisconsin Cancer Center

Ashland, Wisconsin, United States

Site Status RECRUITING

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, United States

Site Status RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Zablocki Veterans Administration Medical Center

Milwaukee, Wisconsin, United States

Site Status RECRUITING

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, United States

Site Status RECRUITING

Drexel Town Square Health Center

Oak Creek, Wisconsin, United States

Site Status RECRUITING

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, United States

Site Status RECRUITING

Aspirus Cancer Care - James Beck Cancer Center

Rhinelander, Wisconsin, United States

Site Status RECRUITING

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, United States

Site Status RECRUITING

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, United States

Site Status RECRUITING

Aspirus Regional Cancer Center

Wausau, Wisconsin, United States

Site Status RECRUITING

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, United States

Site Status RECRUITING

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Site Public Contact

Role: primary

480-278-8261

Site Public Contact

Role: primary

623-773-2873

Site Public Contact

Role: primary

480-278-8261

Site Public Contact

Role: primary

480-278-8261

Site Public Contact

Role: primary

412-339-5294

Site Public Contact

Role: primary

480-278-8261

Site Public Contact

Role: primary

870-936-7066

Site Public Contact

Role: primary

714-522-0908

Site Public Contact

Role: primary

323-865-0451

Site Public Contact

Role: primary

323-865-0451

Site Public Contact

Role: primary

323-865-0451

Site Public Contact

Role: primary

970-569-7429

Site Public Contact

Role: primary

202-741-2210

Site Public Contact

Role: primary

800-679-0775

Site Public Contact

Role: primary

800-679-0775

Site Public Contact

Role: primary

800-679-0775

Site Public Contact

Role: primary

800-679-0775

Site Public Contact

Role: primary

800-679-0775

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

312-695-1301

Site Public Contact

Role: primary

800-446-5532

Site Public Contact

Role: primary

630-352-5360

Site Public Contact

Role: primary

800-446-5532

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

630-352-5360

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

800-446-5532

Site Public Contact

Role: primary

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

800-446-5532

Site Public Contact

Role: primary

630-352-5360

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

515-239-4734

Site Public Contact

Role: primary

515-241-3305

Site Public Contact

Role: primary

319-365-4673

Site Public Contact

Role: primary

319-363-2690

Site Public Contact

Role: primary

515-241-3305

Site Public Contact

Role: primary

515-241-6727

Site Public Contact

Role: primary

515-241-3305

Site Public Contact

Role: primary

515-358-6613

Site Public Contact

Role: primary

515-241-3305

Site Public Contact

Role: primary

800-237-1225

Site Public Contact

Role: primary

515-241-3305

Site Public Contact

Role: primary

913-588-3671

Site Public Contact

Role: primary

913-588-3671

Site Public Contact

Role: primary

270-706-5470

Site Public Contact

Role: primary

443-849-3706

Site Public Contact

Role: primary

313-576-9790

Site Public Contact

Role: primary

313-576-9790

Site Public Contact

Role: primary

313-576-9790

Site Public Contact

Role: primary

313-576-9790

Site Public Contact

Role: primary

313-576-9790

Site Public Contact

Role: primary

313-576-9790

Site Public Contact

Role: primary

313-576-9790

Site Public Contact

Role: primary

313-576-9790

Site Public Contact

Role: primary

313-576-9790

Site Public Contact

Role: primary

313-576-9790

Site Public Contact

Role: primary

313-576-9790

Site Public Contact

Role: primary

218-786-3308

Site Public Contact

Role: primary

901-226-1366

Site Public Contact

Role: primary

901-226-1366

Site Public Contact

Role: primary

901-226-1366

Site Public Contact

Role: primary

901-226-1366

Site Public Contact

Role: primary

901-226-1366

Site Public Contact

Role: primary

573-334-2230

Site Public Contact

Role: primary

573-302-2768

Site Public Contact

Role: primary

702-384-0013

Site Public Contact

Role: primary

800-639-6918

Site Public Contact

Role: primary

505-925-0348

Site Public Contact

Role: primary

718-379-6866

Site Public Contact

Role: primary

718-379-6866

Site Public Contact

Role: primary

800-804-9376

Site Public Contact

Role: primary

800-804-9376

Site Public Contact

Role: primary

980-442-2000

Site Public Contact

Role: primary

800-804-9376

Site Public Contact

Role: primary

800-804-9376

Site Public Contact

Role: primary

888-275-3853

Site Public Contact

Role: primary

704-834-2810

Site Public Contact

Role: primary

800-804-9376

Site Public Contact

Role: primary

336-802-2500

Site Public Contact

Role: primary

980-442-2000

Site Public Contact

Role: primary

800-804-9376

Site Public Contact

Role: primary

336-713-6771

Site Public Contact

Role: primary

330-375-4221

Site Public Contact

Role: primary

330-363-7274

Site Public Contact

Role: primary

513-584-7698

Site Public Contact

Role: primary

800-293-5066

Site Public Contact

Role: primary

513-584-7698

Site Public Contact

Role: primary

405-271-8777

Site Public Contact

Role: primary

412-339-5294

Site Public Contact

Role: primary

717-721-4840

Site Public Contact

Role: primary

412-864-7716

Site Public Contact

Role: primary

877-441-7957

Site Public Contact

Role: primary

717-724-6765

Site Public Contact

Role: primary

717-741-8303

Site Public Contact

Role: primary

412-389-5208

Site Public Contact

Role: primary

412-339-5294

Site Public Contact

Role: primary

412-864-7716

Site Public Contact

Role: primary

412-784-4900

Site Public Contact

Role: primary

412-647-8073

Site Public Contact

Role: primary

412-621-2334

Site Public Contact

Role: primary

412-367-6454

Site Public Contact

Role: primary

412-502-3920

Site Public Contact

Role: primary

877-441-7957

Site Public Contact

Role: primary

800-804-9376

Site Public Contact

Role: primary

800-804-9376

Site Public Contact

Role: primary

800-804-9376

Site Public Contact

Role: primary

901-226-1366

Site Public Contact

Role: primary

865-544-9773

Site Public Contact

Role: primary

901-226-1366

Site Public Contact

Role: primary

800-639-6918

Site Public Contact

Role: primary

Site Public Contact

Role: primary

804-628-6430

Site Public Contact

Role: primary

715-623-9869

Site Public Contact

Role: primary

218-786-3308

Site Public Contact

Role: primary

262-257-5100

Site Public Contact

Role: primary

414-805-3666

Site Public Contact

Role: primary

888-469-6614

Site Public Contact

Role: primary

Site Public Contact

Role: primary

414-805-0505

Site Public Contact

Role: primary

262-928-7878

Site Public Contact

Role: primary

715-847-2353

Site Public Contact

Role: primary

715-847-2353

Site Public Contact

Role: primary

262-928-5539

Site Public Contact

Role: primary

877-405-6866

Site Public Contact

Role: primary

414-805-0505

Site Public Contact

Role: primary

715-422-7718

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2024-03906

Identifier Type: REGISTRY

Identifier Source: secondary_id

NRG-CC013

Identifier Type: OTHER

Identifier Source: secondary_id

NRG-CC013

Identifier Type: OTHER

Identifier Source: secondary_id

NRG-CC013

Identifier Type: OTHER

Identifier Source: secondary_id

UG1CA189867

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NRG-CC013

Identifier Type: -

Identifier Source: org_study_id

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