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

NCT06532279 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: NRG-CC013NCI-2024-03906UG1CA189867
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 149

Brief Summary

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.

Conditions

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 Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8; Stage 0 Hypopharyngeal Carcinoma AJCC v8; Stage 0 Nasopharyngeal Carcinoma AJCC v8; Stage 0 Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage I Head and Neck Cutaneous Squamous Cell Carcinoma 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 Head and Neck Cutaneous Squamous Cell Carcinoma 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 Head and Neck Cutaneous Squamous Cell Carcinoma 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; Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

Outcome Measures

Primary Outcomes (1)

• Incidence of severe oral mucositis (SOM)

  Proportion of patients with reported SOM \>= grade 3 per World Health Organization criteria.

  From start of radiation through 4 weeks after completion of study treatment

Secondary Outcomes (5)

• Duration of SOM

  Up to 12 weeks after completion of chemoradiation

• Time to SOM

  Up to 12 weeks after completion of chemoradiation

• Incidence and duration of xerostomia and radiation dermatitis

  Up to 12 weeks after completion of chemoradiation

• Incidence of toxicity

  Up to 24 months after completion of chemoradiation

• Patient reported oral mucositis

  Up to 24 months after completion of chemoradiation

Other Outcomes (3)

• Pain improvement

  Up to 24 months after completion of chemoradiation

• Progression-free survival (PFS)

  Up to 24 months after completion of chemoradiation

• Overall survival (OS)

  Up to 24 months after completion of chemoradiation

Study Arms (2)

Arm 1 (placebo)

PLACEBO COMPARATOR

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.

Other: Best Practice; Procedure: Biospecimen Collection; Drug: Cisplatin; Procedure: Computed Tomography; Radiation: Image Guided Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Magnetic Resonance Imaging; Drug: Placebo Administration; Other: Questionnaire Administration

Arm 2 (BMX-001)

EXPERIMENTAL

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.

Other: Best Practice; Procedure: Biospecimen Collection; Drug: Cisplatin; Procedure: Computed Tomography; Radiation: Image Guided Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Magnetic Resonance Imaging; Drug: MnSOD Mimetic BMX-001; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive usual symptom management

Also known as: standard of care, standard therapy

Arm 1 (placebo); Arm 2 (BMX-001)

Biospecimen Collection PROCEDURE

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

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm 1 (placebo); Arm 2 (BMX-001)

Cisplatin DRUG

Given cisplatin

Also known as: 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

Arm 1 (placebo); Arm 2 (BMX-001)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Arm 1 (placebo); Arm 2 (BMX-001)

Image Guided Radiation Therapy RADIATION

Undergo image-guided radiation therapy

Also known as: IGRT, Image Guided Radiotherapy, image-guided radiation therapy, Image-Guided Radiotherapy

Arm 1 (placebo); Arm 2 (BMX-001)

Intensity-Modulated Radiation Therapy RADIATION

Undergo intensity-modulated radiation therapy

Also known as: IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy

Arm 1 (placebo); Arm 2 (BMX-001)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: 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

Arm 1 (placebo); Arm 2 (BMX-001)

MnSOD Mimetic BMX-001 DRUG

Given SC

Also known as: 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+

Arm 2 (BMX-001)

Placebo Administration DRUG

Given SC

Arm 1 (placebo)

Questionnaire Administration OTHER

Ancillary studies

Arm 1 (placebo); Arm 2 (BMX-001)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• NRG Oncology: lead

Study Sites (149)

Arizona Center for Cancer Care - Gilbert

Gilbert, Arizona, 85297, United States

RECRUITING

Arizona Center for Cancer Care-Peoria

Peoria, Arizona, 85381, United States

RECRUITING

Arizona Center for Cancer Care - Phoenix

Phoenix, Arizona, 85027, United States

RECRUITING

Arizona Center for Cancer Care - Scottsdale

Scottsdale, Arizona, 85258, United States

RECRUITING

Arizona Center for Cancer Care-Surprise

Surprise, Arizona, 85374, United States

RECRUITING

Arizona Center for Cancer Care

Tempe, Arizona, 85284, United States

RECRUITING

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, 72401, United States

RECRUITING

Keck Medicine of USC Buena Park

Buena Park, California, 90621, United States

RECRUITING

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

RECRUITING

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, 92663, United States

RECRUITING

UC San Diego Medical Center - Hillcrest

San Diego, California, 92103, United States

RECRUITING

Shaw Cancer Center

Edwards, Colorado, 81632, United States

RECRUITING

George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

RECRUITING

Sarasota Memorial Hospital-Venice

North Venice, Florida, 34275, United States

RECRUITING

Moffitt Cancer Center at SouthShore

Ruskin, Florida, 33570, United States

RECRUITING

Florida Cancer Specialists - Sarasota

Sarasota, Florida, 34232, United States

RECRUITING

Florida Cancer Specialists - Sarasota Downtown

Sarasota, Florida, 34236, United States

RECRUITING

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

RECRUITING

Sarasota Memorial Health Care Center at University Parkway

Sarasota, Florida, 34243, United States

RECRUITING

Moffitt Cancer Center-International Plaza

Tampa, Florida, 33607, United States

RECRUITING

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, 33612, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Florida Cancer Specialists - Venice Pinebrook

Venice, Florida, 34275, United States

RECRUITING

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, Florida, 33544, United States

RECRUITING

OSF Saint Joseph Medical Center

Bloomington, Illinois, 61701, United States

RECRUITING

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States

RECRUITING

Illinois CancerCare-Canton

Canton, Illinois, 61520, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Carle at The Riverfront

Danville, Illinois, 61832, United States

RECRUITING

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115, United States

RECRUITING

Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States

RECRUITING

Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States

RECRUITING

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States

RECRUITING

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134, United States

RECRUITING

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States

RECRUITING

Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States

RECRUITING

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States

RECRUITING

Northwestern Medicine Orland Park

Orland Park, Illinois, 60462, United States

RECRUITING

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States

RECRUITING

Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States

RECRUITING

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

RECRUITING

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

RECRUITING

Illinois CancerCare-Peru

Peru, Illinois, 61354, United States

RECRUITING

Illinois CancerCare-Princeton

Princeton, Illinois, 61356, United States

RECRUITING

Carle Cancer Center

Urbana, Illinois, 61801, United States

RECRUITING

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States

RECRUITING

Illinois CancerCare - Washington

Washington, Illinois, 61571, United States

RECRUITING

McFarland Clinic - Ames

Ames, Iowa, 50010, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, 50023, United States

RECRUITING

Mercy Hospital

Cedar Rapids, Iowa, 52403, United States

RECRUITING

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

RECRUITING

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

Clive, Iowa, 50325, United States

RECRUITING

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309, United States

RECRUITING

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, 50314, United States

RECRUITING

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, 50263, United States

RECRUITING

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

RECRUITING

Salina Regional Health Center

Salina, Kansas, 67401, United States

RECRUITING

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States

RECRUITING

Baptist Health Hardin

Elizabethtown, Kentucky, 42701, United States

RECRUITING

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

RECRUITING

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

McLaren Cancer Institute-Bay City

Bay City, Michigan, 48706, United States

RECRUITING

McLaren Cancer Institute-Clarkston

Clarkston, Michigan, 48346, United States

RECRUITING

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334, United States

RECRUITING

McLaren Cancer Institute-Flint

Flint, Michigan, 48532, United States

RECRUITING

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, 48910, United States

RECRUITING

McLaren Cancer Institute-Lapeer Region

Lapeer, Michigan, 48446, United States

RECRUITING

McLaren Cancer Institute-Macomb

Mount Clemens, Michigan, 48043, United States

RECRUITING

McLaren Cancer Institute-Central Michigan

Mount Pleasant, Michigan, 48858, United States

RECRUITING

McLaren Cancer Institute-Northern Michigan

Petoskey, Michigan, 49770, United States

RECRUITING

McLaren-Port Huron

Port Huron, Michigan, 48060, United States

RECRUITING

Miller-Dwan Hospital

Duluth, Minnesota, 55805, United States

RECRUITING

Baptist Memorial Hospital and Cancer Center-Golden Triangle

Columbus, Mississippi, 39705, United States

RECRUITING

Baptist Cancer Center-Grenada

Grenada, Mississippi, 38901, United States

RECRUITING

Baptist Memorial Hospital and Cancer Center-Union County

New Albany, Mississippi, 38652, United States

RECRUITING

Baptist Memorial Hospital and Cancer Center-Oxford

Oxford, Mississippi, 38655, United States

RECRUITING

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, 38671, United States

RECRUITING

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States

RECRUITING

Lake Regional Hospital

Osage Beach, Missouri, 65065, United States

RECRUITING

Renown Regional Medical Center

Reno, Nevada, 89502, United States

RECRUITING

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

RECRUITING

Montefiore Medical Center-Einstein Campus

The Bronx, New York, 10461, United States

RECRUITING

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

RECRUITING

Atrium Health Stanly/LCI-Albemarle

Albemarle, North Carolina, 28002, United States

RECRUITING

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

RECRUITING

Atrium Health Pineville/LCI-Pineville

Charlotte, North Carolina, 28210, United States

RECRUITING

Atrium Health University City/LCI-University

Charlotte, North Carolina, 28262, United States

RECRUITING

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina, 28025, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

CaroMont Regional Medical Center

Gastonia, North Carolina, 28054, United States

RECRUITING

Levine Cancer Institute-Gaston

Gastonia, North Carolina, 28054, United States

RECRUITING

Hayworth Cancer Center

High Point, North Carolina, 27262, United States

RECRUITING

Atrium Health Union/LCI-Union

Monroe, North Carolina, 28112, United States

RECRUITING

Atrium Health Cleveland/LCI-Cleveland

Shelby, North Carolina, 28150, United States

RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Summa Health System - Akron Campus

Akron, Ohio, 44304, United States

RECRUITING

Aultman Health Foundation

Canton, Ohio, 44710, United States

RECRUITING

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, 45069, United States

RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Chambersburg Hospital

Chambersburg, Pennsylvania, 17201, United States

RECRUITING

Ephrata Cancer Center

Ephrata, Pennsylvania, 17522, United States

RECRUITING

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, 16505, United States

RECRUITING

UPMC Cancer Center at UPMC Horizon

Farrell, Pennsylvania, 16121, United States

RECRUITING

Adams Cancer Center

Gettysburg, Pennsylvania, 17325, United States

RECRUITING

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, 17109, United States

RECRUITING

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

RECRUITING

Sechler Family Cancer Center

Lebanon, Pennsylvania, 17042, United States

RECRUITING

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, 17050, United States

RECRUITING

UPMC Cancer Center - Monroeville

Monroeville, Pennsylvania, 15146, United States

RECRUITING

UPMC Hillman Cancer Center - Monroeville

Monroeville, Pennsylvania, 15146, United States

RECRUITING

UPMC Hillman Cancer Center - New Castle

New Castle, Pennsylvania, 16105, United States

RECRUITING

UPMC-Saint Margaret

Pittsburgh, Pennsylvania, 15215, United States

RECRUITING

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, 15237, United States

RECRUITING

UPMC-Saint Clair Hospital Cancer Center

Pittsburgh, Pennsylvania, 15243, United States

RECRUITING

WellSpan Health-York Cancer Center

York, Pennsylvania, 17403, United States

RECRUITING

Lancaster Radiation Therapy Center

Lancaster, South Carolina, 29720, United States

RECRUITING

Rock Hill Radiation Therapy Center

Rock Hill, South Carolina, 29730, United States

RECRUITING

Levine Cancer Institute-Rock Hill

Rock Hill, South Carolina, 29732, United States

RECRUITING

Baptist Memorial Hospital and Cancer Center-Collierville

Collierville, Tennessee, 38017, United States

RECRUITING

University of Tennessee - Knoxville

Knoxville, Tennessee, 37920, United States

RECRUITING

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, 38120, United States

RECRUITING

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, 05819, United States

RECRUITING

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235, United States

RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States

RECRUITING

Langlade Hospital and Cancer Center

Antigo, Wisconsin, 54409, United States

RECRUITING

Northwest Wisconsin Cancer Center

Ashland, Wisconsin, 54806, United States

RECRUITING

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, 53051, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Zablocki Veterans Administration Medical Center

Milwaukee, Wisconsin, 53295, United States

RECRUITING

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, 53149, United States

RECRUITING

Drexel Town Square Health Center

Oak Creek, Wisconsin, 53154, United States

RECRUITING

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066, United States

RECRUITING

Aspirus Cancer Care - James Beck Cancer Center

Rhinelander, Wisconsin, 54501, United States

RECRUITING

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, 54481, United States

RECRUITING

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188, United States

RECRUITING

Aspirus Regional Cancer Center

Wausau, Wisconsin, 54401, United States

RECRUITING

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, 53095, United States

RECRUITING

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, 54494, United States

RECRUITING

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Squamous Cell Carcinoma of Head and Neck; Hypopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Carcinoma; Laryngeal Neoplasms; Mouth Neoplasms; Stomatitis

Interventions

Practice Guidelines as Topic; Standard of Care; Specimen Handling; Cisplatin; 1,2-diaminocyclohexaneplatinum II citrate; Platinum; Radiotherapy, Image-Guided; Radiotherapy, Intensity-Modulated; Magnetic Resonance Spectroscopy; Mn(III) meso-tetrakis(N-n-butoxyethylpyridinium-2-yl)porphyrin

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Carcinoma, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Nasopharyngeal Neoplasms; Nasopharyngeal Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Mouth Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Radiotherapy; Therapeutics; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• David M Brizel

  NRG Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: June 23, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (149)