SUSPENDED

Comparing Cisplatin Every Three Weeks to Cisplatin Weekly When Combined With Radiation for Patients With Advanced Head and Neck Cancer

Conditions

Advanced Head and Neck Squamous Cell Carcinoma Advanced Hypopharyngeal Squamous Cell Carcinoma Advanced Laryngeal Squamous Cell Carcinoma Advanced Oropharyngeal Squamous Cell Carcinoma Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8 Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8 Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8 Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II/III trial compares whether cisplatin given weekly with radiation therapy is better tolerated than cisplatin given every three weeks with radiation therapy for the treatment of head and neck cancer that has spread to other places in the body (advanced). The second part of this study will also help to find out if the cisplatin given weekly approach will extend patients' life by at least the same amount of time as the cisplatin given every three weeks approach. Cisplatin is in a class of medications known as platinum-containing compounds that work by killing, stopping or slowing the growth of cancer cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Radiation with low-dose cisplatin given weekly may be effective in shrinking or stabilizing head and neck cancer or preventing its recurrence.

Official Title

Randomized Phase II/III Trial of Radiation With Cisplatin at 100 mg/m2 Every Three Weeks Versus Radiation With Weekly Cisplatin at 40 mg/m2 for Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Quick Facts

Study Start:2022-02-01

Study Completion:2026-02-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:SUSPENDED

Study ID

NCT05050162

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Pathologically (histologically or cytologically) proven diagnosis of SCCHN of the oropharynx, larynx, hypopharynx, or p16-positive unknown primary prior to registration; specimen from cervical lymph nodes with a well-defined primary site documented clinically or radiologically is acceptable; in patients with carcinoma of unknown primary this will be sufficient for pathologic confirmation without a clinically or radiographically defined primary site * For patients with oropharyngeal cancer (OPC)/cancer of unknown primary (CUP): * Note: Institutions must screen patients for p16 status by immunohistochemistry (IHC) in order to be eligible for the trial using a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. A rigorous laboratory accreditation process similar to the United States (U.S.) CLIA certification, such as the provincial accreditation status offered by the Ontario Laboratory Accreditation (OLA) Program in Canada, the College of American Pathologists (CAP), or an equivalent accreditation in other countries, is acceptable. * The p16 results must be reported on the pathology report being submitted. The p16 positivity is defined as \> 70% of tumor cells showing strong nuclear and/or cytoplasmic immunostaining with p16 antibody. * For patients with laryngeal and hypopharyngeal primaries: Analysis of p16 status is NOT required. * Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. Simple tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving =\< 4 nodes are permitted and considered as non-therapeutic nodal excisions * Clinical stage (American Joint Committee on Cancer \[AJCC\], 8th ed.), including no distant metastases based on the following diagnostic workup: * History/physical examination within 60 days prior to registration * One of the following imaging studies is required within 60 days prior to registration: * Computed tomography (CT) scan of neck (diagnostic quality with contrast, unless contraindicated) OR * Magnetic resonance imaging (MRI) of the neck (diagnostic quality with contrast, unless contraindicated) OR * Fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/CT of the neck; the CT component must be of diagnostic quality with contrast, unless contraindicated. * Note: A diagnostic quality CT or MRI with contrast or FDG-PET/CT scan of neck performed for the purposes of radiation planning may serve as both staging and planning tools * One of the following imaging studies is required within 60 days prior to registration: * FDG-PET/CT of the chest; FDG-PET/CT scan is strongly preferred and highly recommended to be used for eligibility OR * Chest CT * Exam with laryngopharyngoscopy (mirror or in office direct procedure acceptable) within 70 days prior to registration; * Eligibility by patient cohort; * Non-OPC/p16-negative OPC Cohort; Tumor Site: Larynx/Hypopharynx; Clinical Staging (AJCC, 8th ed.): T3-4 N0 or T1-4 N1-3 T2 N0 (hypopharynx only) * Tumor Site: p16-negative OPC; Clinical Staging (AJCC, 8th ed.): T2N1, T1-4 N2-3, or T3-4 N0-1 * p16-positive OPC/CUP Cohort; * Tumor Site: OPC; Smoking Status: =\< 10 pack-years; Clinical Staging (AJCC, 8th ed.): T1-3 N2-3 or T4 N0-3 * Tumor Site: OPC; Smoking Status: \> 10 pack-years; Clinical Staging (AJCC, 8th ed.): T1N2-3, T2N1-3, or T3-4 N0-3 * Tumor Site: CUP; Smoking Status: Any; Clinical Staging (AJCC, 8th ed.): T0 N2-3 Note: Cigar and pipe tobacco consumption is not included in calculating the lifetime pack-years. Marijuana consumption is likewise not considered in this calculation. There is also no clear scientific evidence regarding the role of chewing tobacco-containing products in oropharyngeal cancer, although this is possibly more concerning given the proximity of the oral cavity and oropharynx. In any case, investigators should not count use of non-cigarette tobacco products in the pack-years calculation. * Age \>= 18 * Zubrod (Eastern Cooperative Oncology Group \[ECOG\]) performance status of 0-1 within 14 days prior to registration * Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3 (within 30 days prior to registration) * Platelets \>= 75,000 cells/mm\^3 (within 30 days prior to registration) * Hemoglobin \>= 8.0 g/dL (within 30 days prior to registration) * Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 8.0 g/dL is acceptable) * Calculated creatinine clearance (CrCl) \>= 50 mL/min by the Cockcroft-Gault formula (within 30 days prior to registration) * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (within 30 days prior to registration) (not applicable to patients with known Gilbert's syndrome) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 1.5 x institutional ULN (within 30 days prior to registration) * Known human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months and CD4 T Cell count \> 200 cells/mm\^3 are eligible for this trial. Testing is not required for entry into protocol * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. 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. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes * Willing to use highly effective contraceptives for participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) during therapy and for 14 months (females); for 11 months (males) following last dose of cisplatin; this inclusion is necessary because the treatment in this study may be significantly teratogenic. * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information	* Patients with oral cavity cancer, nasopharynx cancer, or p16-negative cancer of unknown primary (CUP) * Recurrence of the study cancer * Definitive clinical or radiologic evidence of distant metastatic disease * Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable, however, any prior exposure to cisplatin is excluded * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields * Severe, active co-morbidity defined as follows: * Unstable angina requiring hospitalization in the last 6 months * Myocardial infarction within the last 6 months * New York Heart Association Functional Classification III/IV (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.) * Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities that cannot be reversed despite replacement as indicated by repeat testing * Patient must not have an active infection requiring IV antibiotics prior to registration; * Other chronic renal disease like nephrotic syndrome, that could be worsened by cisplatin therapy * History of allogenic organ transplantation * Any symptomatic peripheral sensory neuropathy grade \>= 2 (CTCAE version 5.0); * Pregnancy and individuals unwilling to discontinue nursing * History of hypersensitivity to cisplatin or platinum-containing compounds

Inclusion Criteria

Exclusion Criteria

* Pathologically (histologically or cytologically) proven diagnosis of SCCHN of the oropharynx, larynx, hypopharynx, or p16-positive unknown primary prior to registration; specimen from cervical lymph nodes with a well-defined primary site documented clinically or radiologically is acceptable; in patients with carcinoma of unknown primary this will be sufficient for pathologic confirmation without a clinically or radiographically defined primary site
* For patients with oropharyngeal cancer (OPC)/cancer of unknown primary (CUP):
* Note: Institutions must screen patients for p16 status by immunohistochemistry (IHC) in order to be eligible for the trial using a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. A rigorous laboratory accreditation process similar to the United States (U.S.) CLIA certification, such as the provincial accreditation status offered by the Ontario Laboratory Accreditation (OLA) Program in Canada, the College of American Pathologists (CAP), or an equivalent accreditation in other countries, is acceptable.
* The p16 results must be reported on the pathology report being submitted. The p16 positivity is defined as \> 70% of tumor cells showing strong nuclear and/or cytoplasmic immunostaining with p16 antibody.
* For patients with laryngeal and hypopharyngeal primaries: Analysis of p16 status is NOT required.
* Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. Simple tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving =\< 4 nodes are permitted and considered as non-therapeutic nodal excisions
* Clinical stage (American Joint Committee on Cancer \[AJCC\], 8th ed.), including no distant metastases based on the following diagnostic workup:
* History/physical examination within 60 days prior to registration
* One of the following imaging studies is required within 60 days prior to registration:
* Computed tomography (CT) scan of neck (diagnostic quality with contrast, unless contraindicated) OR
* Magnetic resonance imaging (MRI) of the neck (diagnostic quality with contrast, unless contraindicated) OR
* Fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/CT of the neck; the CT component must be of diagnostic quality with contrast, unless contraindicated.
* Note: A diagnostic quality CT or MRI with contrast or FDG-PET/CT scan of neck performed for the purposes of radiation planning may serve as both staging and planning tools
* One of the following imaging studies is required within 60 days prior to registration:
* FDG-PET/CT of the chest; FDG-PET/CT scan is strongly preferred and highly recommended to be used for eligibility OR
* Chest CT
* Exam with laryngopharyngoscopy (mirror or in office direct procedure acceptable) within 70 days prior to registration;
* Eligibility by patient cohort;
* Non-OPC/p16-negative OPC Cohort; Tumor Site: Larynx/Hypopharynx; Clinical Staging (AJCC, 8th ed.): T3-4 N0 or T1-4 N1-3 T2 N0 (hypopharynx only)
* Tumor Site: p16-negative OPC; Clinical Staging (AJCC, 8th ed.): T2N1, T1-4 N2-3, or T3-4 N0-1
* p16-positive OPC/CUP Cohort;
* Tumor Site: OPC; Smoking Status: =\< 10 pack-years; Clinical Staging (AJCC, 8th ed.): T1-3 N2-3 or T4 N0-3
* Tumor Site: OPC; Smoking Status: \> 10 pack-years; Clinical Staging (AJCC, 8th ed.): T1N2-3, T2N1-3, or T3-4 N0-3
* Tumor Site: CUP; Smoking Status: Any; Clinical Staging (AJCC, 8th ed.): T0 N2-3 Note: Cigar and pipe tobacco consumption is not included in calculating the lifetime pack-years. Marijuana consumption is likewise not considered in this calculation. There is also no clear scientific evidence regarding the role of chewing tobacco-containing products in oropharyngeal cancer, although this is possibly more concerning given the proximity of the oral cavity and oropharynx. In any case, investigators should not count use of non-cigarette tobacco products in the pack-years calculation.
* Age \>= 18
* Zubrod (Eastern Cooperative Oncology Group \[ECOG\]) performance status of 0-1 within 14 days prior to registration
* Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3 (within 30 days prior to registration)
* Platelets \>= 75,000 cells/mm\^3 (within 30 days prior to registration)
* Hemoglobin \>= 8.0 g/dL (within 30 days prior to registration)
* Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 8.0 g/dL is acceptable)
* Calculated creatinine clearance (CrCl) \>= 50 mL/min by the Cockcroft-Gault formula (within 30 days prior to registration)
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (within 30 days prior to registration) (not applicable to patients with known Gilbert's syndrome)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 1.5 x institutional ULN (within 30 days prior to registration)
* Known human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months and CD4 T Cell count \> 200 cells/mm\^3 are eligible for this trial. Testing is not required for entry into protocol
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. 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. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes
* Willing to use highly effective contraceptives for participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) during therapy and for 14 months (females); for 11 months (males) following last dose of cisplatin; this inclusion is necessary because the treatment in this study may be significantly teratogenic.
* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

* Patients with oral cavity cancer, nasopharynx cancer, or p16-negative cancer of unknown primary (CUP)
* Recurrence of the study cancer
* Definitive clinical or radiologic evidence of distant metastatic disease
* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable, however, any prior exposure to cisplatin is excluded
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
* Severe, active co-morbidity defined as follows:
* Unstable angina requiring hospitalization in the last 6 months
* Myocardial infarction within the last 6 months
* New York Heart Association Functional Classification III/IV (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.)
* Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities that cannot be reversed despite replacement as indicated by repeat testing
* Patient must not have an active infection requiring IV antibiotics prior to registration;
* Other chronic renal disease like nephrotic syndrome, that could be worsened by cisplatin therapy
* History of allogenic organ transplantation
* Any symptomatic peripheral sensory neuropathy grade \>= 2 (CTCAE version 5.0);
* Pregnancy and individuals unwilling to discontinue nursing
* History of hypersensitivity to cisplatin or platinum-containing compounds

Contacts and Locations

Principal Investigator

Paul M Harari

PRINCIPAL_INVESTIGATOR

NRG Oncology

Study Locations (Sites)

Mobile Infirmary Medical Center

Mobile, Alabama, 36607

United States

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, 72401

United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205

United States

Kaiser Permanente-Anaheim

Anaheim, California, 92806

United States

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, 94531

United States

Sutter Auburn Faith Hospital

Auburn, California, 95602

United States

Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, 95603

United States

Kaiser Permanente-Bellflower

Bellflower, California, 90706

United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, 94704

United States

Tower Cancer Research Foundation

Beverly Hills, California, 90211

United States

Mercy Cancer Center - Carmichael

Carmichael, California, 95608

United States

Mercy San Juan Medical Center

Carmichael, California, 95608

United States

UC Irvine Health Cancer Center-Newport

Costa Mesa, California, 92627

United States

Kaiser Permanente Dublin

Dublin, California, 94568

United States

Mercy Cancer Center - Elk Grove

Elk Grove, California, 95758

United States

UC San Diego Health System - Encinitas

Encinitas, California, 92024

United States

Kaiser Permanente-Fremont

Fremont, California, 94538

United States

Palo Alto Medical Foundation-Fremont

Fremont, California, 94538

United States

Fresno Cancer Center

Fresno, California, 93720

United States

Kaiser Permanente-Fresno

Fresno, California, 93720

United States

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, 92612

United States

Kaiser Permanente-Irvine

Irvine, California, 92618

United States

UC San Diego Moores Cancer Center

La Jolla, California, 92093

United States

The Angeles Clinic and Research Institute - West Los Angeles Office

Los Angeles, California, 90025

United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027

United States

Cedars Sinai Medical Center

Los Angeles, California, 90048

United States

Fremont - Rideout Cancer Center

Marysville, California, 95901

United States

Memorial Medical Center

Modesto, California, 95355

United States

Kaiser Permanente-Modesto

Modesto, California, 95356

United States

Palo Alto Medical Foundation-Camino Division

Mountain View, California, 94040

United States

Kaiser Permanente Oakland-Broadway

Oakland, California, 94611

United States

Kaiser Permanente-Oakland

Oakland, California, 94611

United States

Kaiser Permanente-Ontario

Ontario, California, 91761

United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868

United States

Palo Alto Medical Foundation Health Care

Palo Alto, California, 94301

United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304

United States

VA Palo Alto Health Care System

Palo Alto, California, 94304

United States

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, 95670

United States

Kaiser Permanente- Marshall Medical Offices

Redwood City, California, 94063

United States

Kaiser Permanente-Richmond

Richmond, California, 94801

United States

Mercy Cancer Center - Rocklin

Rocklin, California, 95765

United States

Rohnert Park Cancer Center

Rohnert Park, California, 94928

United States

Kaiser Permanente-Roseville

Roseville, California, 95661

United States

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, 95661

United States

Sutter Roseville Medical Center

Roseville, California, 95661

United States

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, 95678

United States

Kaiser Permanente Downtown Commons

Sacramento, California, 95814

United States

Mercy Cancer Center - Sacramento

Sacramento, California, 95816

United States

Sutter Medical Center Sacramento

Sacramento, California, 95816

United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817

United States

Kaiser Permanente-South Sacramento

Sacramento, California, 95823

United States

South Sacramento Cancer Center

Sacramento, California, 95823

United States

UC San Diego Medical Center - Hillcrest

San Diego, California, 92103

United States

Kaiser Permanente-San Francisco

San Francisco, California, 94115

United States

UCSF Medical Center-Mount Zion

San Francisco, California, 94115

United States

UCSF Medical Center-Mission Bay

San Francisco, California, 94158

United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, 95119

United States

Stanford Cancer Center South Bay

San Jose, California, 95124

United States

Kaiser Permanente San Leandro

San Leandro, California, 94577

United States

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, 93401

United States

Kaiser San Rafael-Gallinas

San Rafael, California, 94903

United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051

United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, 95403

United States

Sutter Pacific Medical Foundation

Santa Rosa, California, 95403

United States

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, 94080

United States

Kaiser Permanente-South San Francisco

South San Francisco, California, 94080

United States

Kaiser Permanente-Stockton

Stockton, California, 95210

United States

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, 94086

United States

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, 96161

United States

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, 95688

United States

Kaiser Permanente-Vallejo

Vallejo, California, 94589

United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, 94596

United States

Woodland Memorial Hospital

Woodland, California, 95695

United States

Saint Francis Cancer Center

Colorado Springs, Colorado, 80923

United States

Kaiser Permanente-Franklin

Denver, Colorado, 80205

United States

AdventHealth Porter

Denver, Colorado, 80210

United States

Saint Joseph Hospital - Cancer Centers of Colorado

Denver, Colorado, 80218

United States

Lutheran Hospital - Cancer Centers of Colorado

Golden, Colorado, 80401

United States

Kaiser Permanente-Rock Creek

Lafayette, Colorado, 80026

United States

AdventHealth Littleton

Littleton, Colorado, 80122

United States

Kaiser Permanente-Lone Tree

Lone Tree, Colorado, 80124

United States

AdventHealth Parker

Parker, Colorado, 80138

United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007

United States

George Washington University Medical Center

Washington D.C., District of Columbia, 20037

United States

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, 33180

United States

Bay Pines VA Healthcare System

Bay Pines, Florida, 33744

United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146

United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442

United States

UM Sylvester Comprehensive Cancer Center at Doral

Doral, Florida, 33166

United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136

United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, 33176

United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324

United States

Moffitt Cancer Center-International Plaza

Tampa, Florida, 33607

United States

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, 33612

United States

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, Florida, 33544

United States

Augusta University Medical Center

Augusta, Georgia, 30912

United States

Rush-Copley Medical Center

Aurora, Illinois, 60504

United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704

United States

Illinois CancerCare-Canton

Canton, Illinois, 61520

United States

Illinois CancerCare-Carthage

Carthage, Illinois, 62321

United States

Centralia Oncology Clinic

Centralia, Illinois, 62801

United States

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612

United States

Carle at The Riverfront

Danville, Illinois, 61832

United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526

United States

Decatur Memorial Hospital

Decatur, Illinois, 62526

United States

Carle Physician Group-Effingham

Effingham, Illinois, 62401

United States

Crossroads Cancer Center

Effingham, Illinois, 62401

United States

Elmhurst Memorial Hospital

Elmhurst, Illinois, 60126

United States

Illinois CancerCare-Eureka

Eureka, Illinois, 61530

United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401

United States

Edward Hines Jr VA Hospital

Hines, Illinois, 60141

United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443

United States

Illinois CancerCare-Macomb

Macomb, Illinois, 61455

United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938

United States

Loyola University Medical Center

Maywood, Illinois, 60153

United States

Edward Hospital/Cancer Center

Naperville, Illinois, 60540

United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269

United States

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, 62269

United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350

United States

Illinois CancerCare-Pekin

Pekin, Illinois, 61554

United States

Illinois CancerCare-Peoria

Peoria, Illinois, 61615

United States

Methodist Medical Center of Illinois

Peoria, Illinois, 61636

United States

Illinois CancerCare-Peru

Peru, Illinois, 61354

United States

Illinois CancerCare-Princeton

Princeton, Illinois, 61356

United States

UW Health Carbone Cancer Center Rockford

Rockford, Illinois, 61114

United States

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

United States

Springfield Clinic

Springfield, Illinois, 62702

United States

Springfield Memorial Hospital

Springfield, Illinois, 62781

United States

Carle Cancer Center

Urbana, Illinois, 61801

United States

The Carle Foundation Hospital

Urbana, Illinois, 61801

United States

Illinois CancerCare - Washington

Washington, Illinois, 61571

United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, 50023

United States

Mercy Cancer Center-West Lakes

Clive, Iowa, 50325

United States

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

Clive, Iowa, 50325

United States

Greater Regional Medical Center

Creston, Iowa, 50801

United States

Iowa Methodist Medical Center

Des Moines, Iowa, 50309

United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309

United States

Broadlawns Medical Center

Des Moines, Iowa, 50314

United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314

United States

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, 50314

United States

Iowa Lutheran Hospital

Des Moines, Iowa, 50316

United States

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, 50263

United States

Methodist West Hospital

West Des Moines, Iowa, 50266-7700

United States

Mercy Medical Center-West Lakes

West Des Moines, Iowa, 50266

United States

University of Kansas Cancer Center

Kansas City, Kansas, 66160

United States

The University of Kansas Cancer Center - Olathe

Olathe, Kansas, 66061

United States

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210

United States

Salina Regional Health Center

Salina, Kansas, 67401

United States

University of Kansas Health System Saint Francis Campus

Topeka, Kansas, 66606

United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205

United States

Saint Joseph Hospital

Lexington, Kentucky, 40504

United States

Saint Joseph Radiation Oncology Resource Center

Lexington, Kentucky, 40504

United States

Saint Joseph Hospital East

Lexington, Kentucky, 40509

United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536

United States

Jewish Hospital

Louisville, Kentucky, 40202

United States

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202

United States

UofL Health Medical Center Northeast

Louisville, Kentucky, 40245

United States

Louisiana State University Health Science Center

New Orleans, Louisiana, 70112

United States

University Medical Center New Orleans

New Orleans, Louisiana, 70112

United States

MaineHealth Coastal Cancer Treatment Center

Bath, Maine, 04530

United States

MaineHealth Maine Medical Center - Biddeford

Biddeford, Maine, 04005

United States

Lafayette Family Cancer Center-EMMC

Brewer, Maine, 04412

United States

MaineHealth Maine Medical Center - Portland

Portland, Maine, 04102

United States

MaineHealth Cancer Care and IV Therapy - Sanford

Sanford, Maine, 04073

United States

MaineHealth Cancer Care Center of York County

Sanford, Maine, 04073

United States

MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, 04074

United States

MaineHealth Cancer Care and IV Therapy - South Portland

South Portland, Maine, 04106

United States

Maryland Proton Treatment Center

Baltimore, Maryland, 21201

United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201

United States

UM Upper Chesapeake Medical Center

Bel Air, Maryland, 21014

United States

Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, 21044

United States

UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, 21061

United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106

United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109

United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114

United States

Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114

United States

University of Michigan - Brighton Center for Specialty Care

Brighton, Michigan, 48116

United States

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, 48183

United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188

United States

Trinity Health Medical Center - Canton

Canton, Michigan, 48188

United States

Chelsea Hospital

Chelsea, Michigan, 48118

United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118

United States

Michigan Healthcare Professionals Clarkston

Clarkston, Michigan, 48346

United States

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, 48038

United States

Henry Ford Medical Center-Fairlane

Dearborn, Michigan, 48126

United States

Henry Ford Hospital

Detroit, Michigan, 48202

United States

Henry Ford Health Saint John Hospital

Detroit, Michigan, 48236

United States

Michigan Healthcare Professionals Farmington

Farmington Hills, Michigan, 48334

United States

Genesys Hurley Cancer Institute

Flint, Michigan, 48503

United States

Hurley Medical Center

Flint, Michigan, 48503

United States

Allegiance Health

Jackson, Michigan, 49201

United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154

United States

Michigan Healthcare Professionals Macomb

Macomb, Michigan, 48044

United States

Michigan Healthcare Professionals Madison Heights

Madison Heights, Michigan, 48071

United States

Henry Ford Health Providence Novi Hospital

Novi, Michigan, 48374

United States

Henry Ford Medical Center-Columbus

Novi, Michigan, 48377

United States

Michigan Healthcare Professionals Pontiac

Pontiac, Michigan, 48341

United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341

United States

Henry Ford Health Providence Southfield Hospital

Southfield, Michigan, 48075

United States

Michigan Healthcare Professionals Troy

Troy, Michigan, 48098

United States

Henry Ford Health Warren Hospital

Warren, Michigan, 48093

United States

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322

United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197

United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601

United States

Monticello Cancer Center

Monticello, Minnesota, 55362

United States

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, 56303

United States

Baptist Memorial Hospital and Cancer Center-Golden Triangle

Columbus, Mississippi, 39705

United States

Baptist Cancer Center-Grenada

Grenada, Mississippi, 38901

United States

Gulfport Memorial Hospital

Gulfport, Mississippi, 39502

United States

University of Mississippi Medical Center

Jackson, Mississippi, 39216

United States

Baptist Memorial Hospital and Cancer Center-Union County

New Albany, Mississippi, 38652

United States

Baptist Memorial Hospital and Cancer Center-Oxford

Oxford, Mississippi, 38655

United States

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, 38671

United States

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703

United States

Parkland Health Center - Farmington

Farmington, Missouri, 63640

United States

MU Health Care Goldschmidt Cancer Center

Jefferson City, Missouri, 65109

United States

Freeman Health System

Joplin, Missouri, 64804

United States

University of Kansas Cancer Center - North

Kansas City, Missouri, 64154

United States

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064

United States

University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, 64116

United States

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, 65401

United States

Phelps Health Delbert Day Cancer Institute

Rolla, Missouri, 65401

United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670

United States

Mercy Hospital Springfield

Springfield, Missouri, 65804

United States

CoxHealth South Hospital

Springfield, Missouri, 65807

United States

Missouri Baptist Medical Center

St Louis, Missouri, 63131

United States

Mercy Hospital Saint Louis

St Louis, Missouri, 63141

United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080

United States

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, 63127

United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715

United States

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, 59701

United States

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405

United States

Hi-Line Sletten Cancer Center

Havre, Montana, 59501

United States

Nebraska Medicine-Bellevue

Bellevue, Nebraska, 68123

United States

Nebraska Medicine-Village Pointe

Omaha, Nebraska, 68118

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756

United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106

United States

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

Glens Falls Hospital

Glens Falls, New York, 12801

United States

Highland Hospital

Rochester, New York, 14620

United States

University of Rochester

Rochester, New York, 14642

United States

Stony Brook University Medical Center

Stony Brook, New York, 11794

United States

Wilmot Cancer Institute at Webster

Webster, New York, 14580

United States

FirstHealth of the Carolinas-Moore Regional Hospital

Pinehurst, North Carolina, 28374

United States

Novant Cancer Institute Radiation Oncology - Supply

Supply, North Carolina, 28462

United States

Wake Forest Baptist Health - Wilkes Medical Center

Wilkesboro, North Carolina, 28659

United States

Novant Health Cancer Institute Radiation Oncology - Wilmington

Wilmington, North Carolina, 28401

United States

Novant Health New Hanover Regional Medical Center

Wilmington, North Carolina, 28401

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

United States

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501

United States

Sanford Broadway Medical Center

Fargo, North Dakota, 58122

United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122

United States

Summa Health System - Akron Campus

Akron, Ohio, 44304

United States

UH Seidman Cancer Center at UH Avon Health Center

Avon, Ohio, 44011

United States

Summa Health System - Barberton Campus

Barberton, Ohio, 44203

United States

Indu and Raj Soin Medical Center

Beavercreek, Ohio, 45431

United States

Dayton Physicians LLC-Miami Valley South

Centerville, Ohio, 45459

United States

Miami Valley Hospital South

Centerville, Ohio, 45459

United States

Case Western Reserve University

Cleveland, Ohio, 44106

United States

MetroHealth Medical Center

Cleveland, Ohio, 44109

United States

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, 44111

United States

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

United States

Miami Valley Hospital

Dayton, Ohio, 45409

United States

Premier Blood and Cancer Center

Dayton, Ohio, 45409

United States

Dayton Physician LLC - Englewood

Dayton, Ohio, 45415

United States

Miami Valley Hospital North

Dayton, Ohio, 45415

United States

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066

United States

Dayton Physicians LLC-Atrium

Franklin, Ohio, 45005

United States

Miami Valley Cancer Care and Infusion

Greenville, Ohio, 45331

United States

Kettering Medical Center

Kettering, Ohio, 45429

United States

Cleveland Clinic Cancer Center Mansfield

Mansfield, Ohio, 44906

United States

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, 44124

United States

Summa Health Medina Medical Center

Medina, Ohio, 44256

United States

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, 44060

United States

University Hospitals Portage Medical Center

Ravenna, Ohio, 44266

United States

North Coast Cancer Care

Sandusky, Ohio, 44870

United States

Cleveland Clinic Cancer Center Strongsville

Strongsville, Ohio, 44136

United States

ProMedica Flower Hospital

Sylvania, Ohio, 43560

United States

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, 43606

United States

Upper Valley Medical Center

Troy, Ohio, 45373

United States

Cleveland Clinic Wooster Family Health and Surgery Center

Wooster, Ohio, 44691

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010

United States

Saint Vincent Hospital

Erie, Pennsylvania, 16544

United States

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850

United States

Jefferson Hospital

Jefferson Hills, Pennsylvania, 15025

United States

Riddle Memorial Hospital

Media, Pennsylvania, 19063

United States

Forbes Hospital

Monroeville, Pennsylvania, 15146

United States

Paoli Memorial Hospital

Paoli, Pennsylvania, 19301

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

United States

Temple University Hospital

Philadelphia, Pennsylvania, 19140

United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212

United States

Wexford Health and Wellness Pavilion

Wexford, Pennsylvania, 15090

United States

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Self Regional Healthcare

Greenwood, South Carolina, 29646

United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104

United States

Avera Cancer Institute

Sioux Falls, South Dakota, 57105

United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

United States

Baptist Memorial Hospital and Cancer Center-Collierville

Collierville, Tennessee, 38017

United States

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, 38120

United States

Houston Methodist San Jacinto Hospital

Baytown, Texas, 77521

United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030

United States

Ben Taub General Hospital

Houston, Texas, 77030

United States

Houston Methodist Hospital

Houston, Texas, 77030

United States

Michael E DeBakey VA Medical Center

Houston, Texas, 77030

United States

Methodist Willowbrook Hospital

Houston, Texas, 77070

United States

Houston Methodist West Hospital

Houston, Texas, 77094

United States

Houston Methodist Saint John Hospital

Nassau Bay, Texas, 77058

United States

Houston Methodist Sugar Land Hospital

Sugar Land, Texas, 77479

United States

Houston Methodist The Woodlands Hospital

The Woodlands, Texas, 77385

United States

American Fork Hospital / Huntsman Intermountain Cancer Center

American Fork, Utah, 84003

United States

Sandra L Maxwell Cancer Center

Cedar City, Utah, 84720

United States

Logan Regional Hospital

Logan, Utah, 84321

United States

Intermountain Medical Center

Murray, Utah, 84107

United States

McKay-Dee Hospital Center

Ogden, Utah, 84403

United States

Utah Valley Regional Medical Center

Provo, Utah, 84604

United States

Riverton Hospital

Riverton, Utah, 84065

United States

Utah Cancer Specialists-Salt Lake City

Salt Lake City, Utah, 84106

United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112

United States

LDS Hospital

Salt Lake City, Utah, 84143

United States

Saint George Regional Medical Center

St. George, Utah, 84770

United States

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, 05819

United States

Inova Alexandria Hospital

Alexandria, Virginia, 22304

United States

Inova Schar Cancer Institute

Fairfax, Virginia, 22031

United States

Inova Fair Oaks Hospital

Fairfax, Virginia, 22033

United States

FHCC Overlake

Bellevue, Washington, 98004

United States

FHCC at EvergreenHealth

Kirkland, Washington, 98034

United States

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

United States

FHCC at Northwest Hospital

Seattle, Washington, 98133

United States

University of Washington Medical Center - Montlake

Seattle, Washington, 98195

United States

West Virginia University Charleston Division

Charleston, West Virginia, 25304

United States

Langlade Hospital and Cancer Center

Antigo, Wisconsin, 54409

United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701

United States

University of Wisconsin Carbone Cancer Center - Johnson Creek

Johnson Creek, Wisconsin, 53038

United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601

United States

William S Middleton VA Medical Center

Madison, Wisconsin, 53705

United States

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, 53718

United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792

United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449

United States

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, 53051

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Zablocki Veterans Administration Medical Center

Milwaukee, Wisconsin, 53295

United States

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548

United States

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, 53149

United States

Drexel Town Square Health Center

Oak Creek, Wisconsin, 53154

United States

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066

United States

Aspirus Cancer Care - James Beck Cancer Center

Rhinelander, Wisconsin, 54501

United States

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868

United States

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, 54481

United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482

United States

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188

United States

Aspirus Regional Cancer Center

Wausau, Wisconsin, 54401

United States

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, 53095

United States

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476

United States

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, 54494

United States

Collaborators and Investigators

Sponsor: NRG Oncology

Paul M Harari, PRINCIPAL_INVESTIGATOR, NRG Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-01

Study Completion Date2026-02-09

Study Record Updates

Study Start Date2022-02-01

Study Completion Date2026-02-09

Terms related to this study

Additional Relevant MeSH Terms

Advanced Head and Neck Squamous Cell Carcinoma
Advanced Hypopharyngeal Squamous Cell Carcinoma
Advanced Laryngeal Squamous Cell Carcinoma
Advanced Oropharyngeal Squamous Cell Carcinoma
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8