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Comparing High-Dose Cisplatin Every Three Weeks to Low-Dose Cisplatin Weekly When Combined with Radiation for Patients with Advanced Head and Neck Cancer

Trial Status: Active

This phase II / III trial compares whether low-dose cisplatin given weekly with radiation therapy is better tolerated than high-dose 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 low-dose cisplatin approach will extend patients’ life by at least the same amount of time as the high-dose cisplatin 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.

Inclusion 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): P16 status based on local site immunohistochemical tissue staining is required. A cell block obtained from a fine needle aspiration (FNA) biopsy specimen may be used as the sole diagnostic tissue. Centers are encouraged to contact the pathology chair for clarification. ** 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 should 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.): T1-2 N2-3 or T3-4 N0-3 *** Tumor Site: CUP; Smoking Status: Any; Clinical Staging (AJCC, 8th ed.): T0 N2-3
  • 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

Exclusion Criteria

  • 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

California

Anaheim
Kaiser Permanente-Anaheim
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
Antioch
Kaiser Permanente-Deer Valley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Berkeley
Alta Bates Summit Medical Center-Herrick Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2683
Beverly Hills
Tower Cancer Research Foundation
Status: ACTIVE
Contact: Site Public Contact
Dublin
Kaiser Permanente Dublin
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Fremont
Kaiser Permanente-Fremont
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Fresno
Fresno Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Kaiser Permanente-Fresno
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
La Jolla
UC San Diego Moores Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 858-822-5354
Los Angeles
Cedars Sinai Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 310-423-8965
Kaiser Permanente Los Angeles Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
Marysville
Fremont - Rideout Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 530-749-4400
Modesto
Kaiser Permanente-Modesto
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Mountain View
Palo Alto Medical Foundation-Camino Division
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2683
Oakland
Kaiser Permanente Oakland-Broadway
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Kaiser Permanente-Oakland
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Ontario
Kaiser Permanente-Ontario
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
Palo Alto
Palo Alto Medical Foundation Health Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2683
Stanford Cancer Institute Palo Alto
Status: ACTIVE
Contact: Site Public Contact
Phone: 650-498-7061
Rancho Cordova
Kaiser Permanente-Rancho Cordova Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Redwood City
Kaiser Permanente- Marshall Medical Offices
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Richmond
Kaiser Permanente-Richmond
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Rohnert Park
Rohnert Park Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Roseville
Kaiser Permanente-Roseville
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
The Permanente Medical Group-Roseville Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Sacramento
Kaiser Permanente Downtown Commons
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: kpoct@kp.org
Kaiser Permanente-South Sacramento
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
South Sacramento Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Sutter Medical Center Sacramento
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2683
University of California Davis Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 916-734-3089
San Francisco
Kaiser Permanente-San Francisco
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Jose
Kaiser Permanente-Santa Teresa-San Jose
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Stanford Cancer Center South Bay
Status: ACTIVE
Contact: Site Public Contact
Phone: 650-498-7061
San Rafael
Kaiser San Rafael-Gallinas
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Santa Clara
Kaiser Permanente Medical Center - Santa Clara
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Santa Rosa
Kaiser Permanente-Santa Rosa
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
South San Francisco
Kaiser Permanente Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Kaiser Permanente-South San Francisco
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Stockton
Kaiser Permanente-Stockton
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Sunnyvale
Palo Alto Medical Foundation-Sunnyvale
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2683
Truckee
Gene Upshaw Memorial Tahoe Forest Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 530-582-6450
Vacaville
Kaiser Permanente Medical Center-Vacaville
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Vallejo
Kaiser Permanente-Vallejo
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Walnut Creek
Kaiser Permanente-Walnut Creek
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org

Colorado

Denver
Porter Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 719-776-6550
Littleton
Littleton Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 719-776-6550
Parker
Parker Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 719-776-6550

Florida

Tampa
Moffitt Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-679-0775
Moffitt Cancer Center - McKinley Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-679-0775
Moffitt Cancer Center-International Plaza
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-679-0775

Illinois

Aurora
Rush - Copley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-978-6212
Bloomington
Illinois CancerCare-Bloomington
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Canton
Illinois CancerCare-Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Carthage
Illinois CancerCare-Carthage
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Centralia
Centralia Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Danville
Carle on Vermilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Effingham
Carle Physician Group-Effingham
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Eureka
Illinois CancerCare-Eureka
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Galesburg
Illinois CancerCare-Galesburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Macomb
Illinois CancerCare-Macomb
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Maywood
Loyola University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 708-226-4357
O'Fallon
Cancer Care Center of O'Fallon
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Pekin
Illinois CancerCare-Pekin
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Peoria
Illinois CancerCare-Peoria
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Methodist Medical Center of Illinois
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Peru
Illinois CancerCare-Peru
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Princeton
Illinois CancerCare-Princeton
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Rockford
SwedishAmerican Regional Cancer Center / ACT
Status: ACTIVE
Contact: Site Public Contact
Phone: 779-696-9400
Springfield
Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-528-7541
Southern Illinois University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-545-7929
Springfield Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-444-7541
Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
The Carle Foundation Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Washington
Illinois CancerCare - Washington
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605

Iowa

Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-358-6613
Mercy Cancer Center-West Lakes
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-358-6613
Creston
Greater Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-358-6613
Des Moines
Broadlawns Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-282-2200
Iowa Lutheran Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-241-8704
Iowa Methodist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-241-6727
Medical Oncology and Hematology Associates-Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-282-2921
Medical Oncology and Hematology Associates-Laurel
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-358-6613
Mercy Medical Center - Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-358-6613
West Des Moines
Mercy Medical Center-West Lakes
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-358-6613
Methodist West Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-343-1000

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
Overland Park
University of Kansas Cancer Center-Overland Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
Topeka
University of Kansas Health System Saint Francis Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 785-295-8000
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671

Kentucky

Louisville
Jewish Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 859-629-7169
The James Graham Brown Cancer Center at University of Louisville
Status: ACTIVE
Contact: Site Public Contact
Phone: 502-562-3429

Louisiana

New Orleans
Louisiana State University Health Science Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-210-3539
University Medical Center New Orleans
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-210-3539

Maine

Bath
MaineHealth Coastal Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294
Biddeford
MaineHealth / SMHC Cancer Care and Blood Disorders-Biddeford
Status: ACTIVE
Contact: Site Public Contact
Brewer
Lafayette Family Cancer Center-EMMC
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-987-3005
Portland
Maine Medical Center-Bramhall Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 207-885-7565
Sanford
MaineHealth / SMHC Cancer Care and Blood Disorders-Sanford
Status: ACTIVE
Contact: Site Public Contact
MaineHealth Cancer Care Center of York County
Status: ACTIVE
Contact: Site Public Contact
Phone: 207-459-1600
Scarborough
Maine Medical Center- Scarborough Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 207-396-8090
South Portland
Maine Medical Partners - South Portland
Status: ACTIVE
Contact: Site Public Contact
Phone: 207-396-8670

Maryland

Baltimore
Maryland Proton Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 410-369-5226
University of Maryland / Greenebaum Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-888-8823
Bel Air
UM Upper Chesapeake Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 443-643-3010
Columbia
Central Maryland Radiation Oncology in Howard County
Status: ACTIVE
Contact: Site Public Contact
Phone: 443-546-1300
Glen Burnie
UM Baltimore Washington Medical Center / Tate Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 410-553-8100

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Brighton
Saint Joseph Mercy Brighton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Brownstown
Henry Ford Cancer Institute-Downriver
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Canton
Saint Joseph Mercy Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Trinity Health IHA Medical Group Hematology Oncology - Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Chelsea
Saint Joseph Mercy Chelsea
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Clarkston
GenesisCare USA - Clarkston
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Dearborn
Henry Ford Medical Center-Fairlane
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Detroit
Ascension Saint John Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-343-3166
Henry Ford Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Farmington Hills
GenesisCare USA - Farmington Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
Flint
Genesys Hurley Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 810-762-8038
Hurley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 810-762-8038
Livonia
Trinity Health Saint Mary Mercy Livonia Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Macomb
GenesisCare USA - Macomb
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
Madison Heights
GenesisCare USA - Madison Heights
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
Novi
Henry Ford Medical Center-Columbus
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Troy
GenesisCare USA - Troy
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
Warren
Saint John Macomb-Oakland Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-343-3166
West Bloomfield
Henry Ford West Bloomfield Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Ypsilanti
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251

Minnesota

Bemidji
Sanford Joe Lueken Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-333-5000

Missouri

Cape Girardeau
Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Farmington
Parkland Health Center - Farmington
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Kansas City
University of Kansas Cancer Center - North
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
Lee's Summit
University of Kansas Cancer Center - Lee's Summit
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
North Kansas City
University of Kansas Cancer Center at North Kansas City Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
Saint Louis
Missouri Baptist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Springfield
CoxHealth South Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Mercy Hospital Springfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Sullivan
Missouri Baptist Sullivan Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569

Montana

Butte
Saint James Community Hospital and Cancer Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-723-2621

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-639-6918

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-925-0366

New York

Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-767-9355
Rochester
Highland Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-341-8113
University of Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-275-5830
Stony Brook
Stony Brook University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-862-2215

North Carolina

Pinehurst
FirstHealth of the Carolinas-Moore Regional Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 910-715-3500
Wilkesboro
Wake Forest Baptist Health - Wilkes Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-716-9253
Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE
Contact: Site Public Contact
Phone: 336-713-6771

North Dakota

Fargo
Sanford Broadway Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-323-5760
Sanford Roger Maris Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-234-6161

Ohio

Akron
Summa Health System - Akron Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 330-375-4221
Barberton
Summa Health System - Barberton Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 330-375-4221
Cleveland
Cleveland Clinic Cancer Center / Fairview Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Cleveland Clinic Foundation
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Mansfield
Cleveland Clinic Cancer Center Mansfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Mayfield Heights
Hillcrest Hospital Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Medina
Summa Health Medina Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 330-375-4221
Sandusky
North Coast Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Strongsville
Cleveland Clinic Cancer Center Strongsville
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Sylvania
ProMedica Flower Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 419-824-1842
Toledo
ProMedica Toledo Hospital / Russell J Ebeid Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 419-824-1842
Wooster
Cleveland Clinic Wooster Family Health and Surgery Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777

Pennsylvania

Hershey
Penn State Milton S Hershey Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 717-531-3779
Jefferson Hills
Jefferson Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-359-3043
Monroeville
Forbes Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-858-7746
Philadelphia
Fox Chase Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 215-728-4790
Temple University Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 215-728-2983
Pittsburgh
Allegheny General Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-284-2000
Wexford
Wexford Health and Wellness Pavilion
Status: ACTIVE
Contact: Site Public Contact

South Carolina

Greenwood
Self Regional Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-725-4771

South Dakota

Sioux Falls
Sanford Cancer Center Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320
Sanford USD Medical Center - Sioux Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-424-2100

Vermont

Saint Johnsbury
Norris Cotton Cancer Center-North
Status: ACTIVE
Contact: Site Public Contact
Phone: 802-473-4100

Virginia

Fairfax
Inova Schar Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 703-720-5210

Wisconsin

Antigo
Langlade Hospital and Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 715-623-9869
Johnson Creek
UW Cancer Center Johnson Creek
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-699-3500
La Crosse
Gundersen Lutheran Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 608-775-2385
Madison
University of Wisconsin Carbone Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-622-8922
Milwaukee
Zablocki Veterans Administration Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-469-6614
Mukwonago
ProHealth D N Greenwald Center
Status: ACTIVE
Contact: Site Public Contact
Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 262-928-7878
Waukesha
UW Cancer Center at ProHealth Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 262-928-5539
Wausau
Aspirus Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-405-6866
Wisconsin Rapids
Aspirus Cancer Care - Wisconsin Rapids
Status: ACTIVE
Contact: Site Public Contact
Phone: 715-422-7718

PRIMARY OBJECTIVES:

I. To determine whether radiation with low-dose cisplatin weekly is superior in terms of acute toxicity, as measured by the T-scores (TAME method), to radiation with high-dose cisplatin every 3 weeks for patients with locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN). (Phase II)

II. To determine whether radiation with low-dose cisplatin weekly is non-inferior to radiation with high-dose cisplatin every 3 weeks in terms of overall survival (OS) for patients with locoregionally advanced SCCHN. (Phase III)

III. To determine whether radiation with low-dose cisplatin weekly is superior in terms of acute toxicity, as measured by the T-scores (TAME method), to radiation with high-dose cisplatin every 3 weeks for patients with locoregionally advanced SCCHN. (Phase III)

SECONDARY OBJECTIVES:

I. To assess and compare progression-free survival (PFS) between arms.

II. To assess and compare locoregional failure and distant metastasis between arms.

III. To assess acute and late toxicity (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0).

IV. To assess patient-reported outcomes quality of life (PRO/QOL), as measured by the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) (primary PRO), between arms.

V. To assess hearing loss, as measured by audiograms and the modified TUNE grading scale between arms.

VI. To assess hearing loss, as measured by speech audiometry Consonant-Nucleus-Consonant word scores and tympanometry (subject to the modified TUNE grading scale testing results; otherwise, it will be an exploratory objective).

VII. To assess hearing-related QOL as measured by the Hearing Handicap Inventory-Screening (HHIA-S) (secondary PRO), between arms.

EXPLORATORY OBJECTIVE:

I. To collect blood and tissue specimens for future translational science studies. For instance, to examine how germline and somatic genetic variants, such as TP53, CDKN2A, PIK3CA, PTEN, NFE2L2, and KEAP1, may influence cisplatin-related efficacy and toxicity, and to assess the effect of regular nonsteroidal anti-inflammatory drugs (NSAIDs) use and genomic activation of PIK3CA (mutation or amplification) or loss of PTEN, the negative regulator of PI3K, on disease-free survival or overall survival.

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM I (NON-OROPHARYNGEAL CANCER [OPC]/p16-NEGATIVE OPC group and p16-NEGATIVE OPC/CANCER OF UNKNOWN PRIMARY [CUP] group): Patients undergo radiation therapy over 5 fractions a week for a total of 33-35 fractions in the absence of disease progression or unacceptable toxicity. Patients also receive high-dose cisplatin intravenously (IV) once every 3 weeks (Q3W) (on days 1, 22, and 43) during radiation therapy in the absence of disease progression or unacceptable toxicity.

ARM II (NON-OROPHARYNGEAL CANCER [OPC]/p16-NEGATIVE OPC group and p16-NEGATIVE OPC/CANCER OF UNKNOWN PRIMARY [CUP] group): Patients undergo radiation therapy over 5 fractions a week for a total of 33-35 fractions in the absence of disease progression or unacceptable toxicity. Patients also receive low-dose cisplatin IV once a week (QW) during radiation therapy in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 month, every 3 months during year 1-2, every 6 months during year 3-5, then annually thereafter.

Trial Phase Phase II/III

Trial Type Treatment

Lead Organization
NRG Oncology

Principal Investigator
Paul Maurice Harari

  • Primary ID NRG-HN009
  • Secondary IDs NCI-2021-08925
  • Clinicaltrials.gov ID NCT05050162