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

Purpose

This phase II/III trial compares the effect of the combination of high-dose cisplatin every three weeks and radiation therapy versus low-dose cisplatin weekly and radiation therapy for the treatment of patients with locoregionally advanced head and neck cancer. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This study is being done to find out if low-dose cisplatin given weekly together with radiation therapy is the same or better than high-dose cisplatin given every 3 weeks together with radiation therapy in treating patients with 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
  • Squamous Cell Carcinoma of Unknown Primary

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 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

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 - History of hypersensitivity to cisplatin or platinum-containing compounds

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ARM I (high-dose cisplatin, radiation therapy)
NON-OPC/p16-NEGATIVE OPC: 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 IV Q3W (on days 1, 22, and 43) during radiation therapy in the absence of disease progression or unacceptable toxicity.
  • Drug: Cisplatin
    Given high-dose cisplatin IV
    Other names:
    • 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
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
  • Radiation: Radiation Therapy
    Undergo radiation therapy
    Other names:
    • Cancer Radiotherapy
    • ENERGY_TYPE
    • Irradiate
    • Irradiated
    • Irradiation
    • Radiation
    • Radiation Therapy, NOS
    • Radiotherapeutics
    • Radiotherapy
    • RT
    • Therapy, Radiation
Experimental
Arm II (low-dose cisplatin, radiation therapy)
NON-OPC/p16-NEGATIVE OPC: 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 QW during radiation therapy in the absence of disease progression or unacceptable toxicity.
  • Drug: Cisplatin
    Given low-dose cisplatin IV
    Other names:
    • 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
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
  • Radiation: Radiation Therapy
    Undergo radiation therapy
    Other names:
    • Cancer Radiotherapy
    • ENERGY_TYPE
    • Irradiate
    • Irradiated
    • Irradiation
    • Radiation
    • Radiation Therapy, NOS
    • Radiotherapeutics
    • Radiotherapy
    • RT
    • Therapy, Radiation
Experimental
Arm III (high-dose cisplatin, radiation therapy)
p16-POSITIVE OPC/CUP: 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 IV Q3W (on days 1, 22, and 43) during radiation therapy in the absence of disease progression or unacceptable toxicity.
  • Drug: Cisplatin
    Given high-dose cisplatin IV
    Other names:
    • 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
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
  • Radiation: Radiation Therapy
    Undergo radiation therapy
    Other names:
    • Cancer Radiotherapy
    • ENERGY_TYPE
    • Irradiate
    • Irradiated
    • Irradiation
    • Radiation
    • Radiation Therapy, NOS
    • Radiotherapeutics
    • Radiotherapy
    • RT
    • Therapy, Radiation
Experimental
Arm IV (low-dose cisplatin, radiation therapy)
p16-POSITIVE OPC/CUP: 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 QW during radiation therapy in the absence of disease progression or unacceptable toxicity.
  • Drug: Cisplatin
    Given low-dose cisplatin IV
    Other names:
    • 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
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
  • Radiation: Radiation Therapy
    Undergo radiation therapy
    Other names:
    • Cancer Radiotherapy
    • ENERGY_TYPE
    • Irradiate
    • Irradiated
    • Irradiation
    • Radiation
    • Radiation Therapy, NOS
    • Radiotherapeutics
    • Radiotherapy
    • RT
    • Therapy, Radiation

Recruiting Locations

Mobile Infirmary Medical Center
Mobile, Alabama 36607
Contact:
Site Public Contact
251-435-3942

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas 72401
Contact:
Site Public Contact
870-936-7066
Emily.Carvell@bmhcc.org

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274

Kaiser Permanente-Anaheim
Anaheim, California 92806
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente-Deer Valley Medical Center
Antioch, California 94531
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Sutter Auburn Faith Hospital
Auburn, California 95602
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California 95603
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California 94704
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Tower Cancer Research Foundation
Beverly Hills, California 90211
Contact:
Site Public Contact
towercancerresearch@toweroncology.com

Mercy Cancer Center �� Carmichael
Carmichael, California 95608
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Mercy San Juan Medical Center
Carmichael, California 95608
Contact:
Site Public Contact
916-556-3301
OncologyResearch@DignityHealth.org

Kaiser Permanente Dublin
Dublin, California 94568
Contact:
Site Public Contact
877-642-4691

Mercy Cancer Center - Elk Grove
Elk Grove, California 95758
Contact:
Site Public Contact
916-556-3301
OncologyResearch@DignityHealth.org

Kaiser Permanente-Fremont
Fremont, California 94538
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Fresno Cancer Center
Fresno, California 93720
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Fresno
Fresno, California 93720
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

UC San Diego Moores Cancer Center
La Jolla, California 92093
Contact:
Site Public Contact
858-822-5354
cancercto@ucsd.edu

Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Cedars Sinai Medical Center
Los Angeles, California 90048
Contact:
Site Public Contact
310-423-8965

Fremont - Rideout Cancer Center
Marysville, California 95901
Contact:
Site Public Contact
530-749-4400

Memorial Medical Center
Modesto, California 95355
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Kaiser Permanente-Modesto
Modesto, California 95356
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Palo Alto Medical Foundation-Camino Division
Mountain View, California 94040
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Kaiser Permanente Oakland-Broadway
Oakland, California 94611
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Oakland
Oakland, California 94611
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Ontario
Ontario, California 91761
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Palo Alto Medical Foundation Health Care
Palo Alto, California 94301
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Stanford Cancer Institute Palo Alto
Palo Alto, California 94304
Contact:
Site Public Contact
650-498-7061
ccto-office@stanford.edu

Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California 95670
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente- Marshall Medical Offices
Redwood City, California 94063
Contact:
Site Public Contact
877-642-4691

Kaiser Permanente-Richmond
Richmond, California 94801
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Mercy Cancer Center - Rocklin
Rocklin, California 95765
Contact:
Site Public Contact
916-556-3301
OncologyResearch@DignityHealth.org

Rohnert Park Cancer Center
Rohnert Park, California 94928
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Roseville
Roseville, California 95661
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California 95661
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Sutter Roseville Medical Center
Roseville, California 95661
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California 95678
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente Downtown Commons
Sacramento, California 95814
Contact:
Site Public Contact
877-642-4691
kpoct@kp.org

Mercy Cancer Center - Sacramento
Sacramento, California 95816
Contact:
Site Public Contact
916-556-3301
OncologyResearch@DignityHealth.org

Sutter Medical Center Sacramento
Sacramento, California 95816
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
Contact:
Site Public Contact
916-734-3089

Kaiser Permanente-South Sacramento
Sacramento, California 95823
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

South Sacramento Cancer Center
Sacramento, California 95823
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-San Francisco
San Francisco, California 94115
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

UCSF Medical Center-Mount Zion
San Francisco, California 94115
Contact:
Site Public Contact
877-827-3222

UCSF Medical Center-Mission Bay
San Francisco, California 94158
Contact:
Site Public Contact
877-827-3222
cancertrials@ucsf.edu

Kaiser Permanente-Santa Teresa-San Jose
San Jose, California 95119
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Stanford Cancer Center South Bay
San Jose, California 95124
Contact:
Site Public Contact
650-498-7061
ccto-office@stanford.edu

Kaiser Permanente San Leandro
San Leandro, California 94577
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser San Rafael-Gallinas
San Rafael, California 94903
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California 95051
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Santa Rosa
Santa Rosa, California 95403
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente Cancer Treatment Center
South San Francisco, California 94080
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-South San Francisco
South San Francisco, California 94080
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Stockton
Stockton, California 95210
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California 94086
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California 96161
Contact:
Site Public Contact
530-582-6450

Kaiser Permanente Medical Center-Vacaville
Vacaville, California 95688
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Vallejo
Vallejo, California 94589
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Walnut Creek
Walnut Creek, California 94596
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Woodland Memorial Hospital
Woodland, California 95695
Contact:
Site Public Contact
916-556-3301
OncologyResearch@DignityHealth.org

Kaiser Permanente-Franklin
Denver, Colorado 80205
Contact:
Site Public Contact
303-720-2685
kristi.m.bronkan@kp.org

SCL Health Saint Joseph Hospital
Denver, Colorado 80218
Contact:
Site Public Contact
303-318-3413
alan.franklin@sclhealth.org

SCL Health Cancer Centers of Colorado - Lutheran Medical Center
Golden, Colorado 80401
Contact:
Site Public Contact
303-813-5225
Alan.miller@sclhealth.org

Kaiser Permanente-Rock Creek
Lafayette, Colorado 80026
Contact:
Site Public Contact
303-720-2685
kristi.m.bronkan@kp.org

Kaiser Permanente-Lone Tree
Lone Tree, Colorado 80124
Contact:
Site Public Contact
303-720-2685
kristi.m.bronkan@kp.org

George Washington University Medical Center
Washington, District of Columbia 20037
Contact:
Site Public Contact
202-741-2981

UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida 33180
Contact:
Site Public Contact
954-461-2180

Veterans Administration Hospital
Bay Pines, Florida 33744
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida 33146
Contact:
Site Public Contact
305-243-2647

UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida 33442
Contact:
Site Public Contact
305-243-2647

University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
Contact:
Site Public Contact
305-243-2647

UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida 33176
Contact:
Site Public Contact
305-243-2647

UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida 33324
Contact:
Site Public Contact
305-243-2647

Moffitt Cancer Center-International Plaza
Tampa, Florida 33607
Contact:
Site Public Contact
800-679-0775
ClinicalTrials@moffitt.org

Moffitt Cancer Center - McKinley Campus
Tampa, Florida 33612
Contact:
Site Public Contact
800-679-0775
ClinicalTrials@moffitt.org

Moffitt Cancer Center
Tampa, Florida 33612
Contact:
Site Public Contact
800-679-0775
ClinicalTrials@moffitt.org

Augusta University Medical Center
Augusta, Georgia 30912
Contact:
Site Public Contact
706-721-2388
ga_cares@augusta.edu

Rush - Copley Medical Center
Aurora, Illinois 60504
Contact:
Site Public Contact
630-978-6212
Cancer.Research@rushcopley.com

Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Canton
Canton, Illinois 61520
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Carthage
Carthage, Illinois 62321
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Centralia Oncology Clinic
Centralia, Illinois 62801
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

John H Stroger Jr Hospital of Cook County
Chicago, Illinois 60612
Contact:
Site Public Contact
312-864-5204

Carle at The Riverfront
Danville, Illinois 61832
Contact:
Site Public Contact
800-446-5532
Research@Carle.com

Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Carle Physician Group-Effingham
Effingham, Illinois 62401
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Crossroads Cancer Center
Effingham, Illinois 62401
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Illinois CancerCare-Eureka
Eureka, Illinois 61530
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Edward Hines Jr VA Hospital
Hines, Illinois 60141
Contact:
Site Public Contact
708-202-8387

Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Macomb
Macomb, Illinois 61455
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Loyola University Medical Center
Maywood, Illinois 60153
Contact:
Site Public Contact
708-226-4357

Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Pekin
Pekin, Illinois 61554
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peoria
Peoria, Illinois 61615
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Methodist Medical Center of Illinois
Peoria, Illinois 61636
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peru
Peru, Illinois 61354
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Princeton
Princeton, Illinois 61356
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

SwedishAmerican Regional Cancer Center/ACT
Rockford, Illinois 61114
Contact:
Site Public Contact
779-696-9378
lkline@uwhealth.org

Southern Illinois University School of Medicine
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929

Springfield Clinic
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541

Memorial Medical Center
Springfield, Illinois 62781
Contact:
Site Public Contact
217-528-7541
pallante.beth@mhsil.com

Carle Cancer Center
Urbana, Illinois 61801
Contact:
Site Public Contact
800-446-5532
Research@carle.com

The Carle Foundation Hospital
Urbana, Illinois 61801
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Illinois CancerCare - Washington
Washington, Illinois 61571
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Mission Cancer and Blood - Ankeny
Ankeny, Iowa 50023
Contact:
Site Public Contact
515-282-2921

Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa 50325
Contact:
Site Public Contact
515-241-3305

Mercy Cancer Center-West Lakes
Clive, Iowa 50325
Contact:
Site Public Contact
515-358-6613
cancerresearch@mercydesmoines.org

Greater Regional Medical Center
Creston, Iowa 50801
Contact:
Site Public Contact
515-358-6613
cancerresearch@mercydesmoines.org

Iowa Methodist Medical Center
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-6727

Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-3305

Broadlawns Medical Center
Des Moines, Iowa 50314
Contact:
Site Public Contact
515-282-2200

Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
Contact:
Site Public Contact
515-358-6613
cancerresearch@mercydesmoines.org

Mission Cancer and Blood - Laurel
Des Moines, Iowa 50314
Contact:
Site Public Contact
515-241-3305

Iowa Lutheran Hospital
Des Moines, Iowa 50316
Contact:
Site Public Contact
515-241-8704

Methodist West Hospital
West Des Moines, Iowa 50266-7700
Contact:
Site Public Contact
515-343-1000

Mercy Medical Center-West Lakes
West Des Moines, Iowa 50266
Contact:
Site Public Contact
515-358-6613
cancerresearch@mercydesmoines.org

University of Kansas Cancer Center
Kansas City, Kansas 66160
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Olathe Health Cancer Center
Olathe, Kansas 66061
Contact:
Site Public Contact
913-355-8000
Jeni.wakefield@olathehealth.org

University of Kansas Cancer Center-Overland Park
Overland Park, Kansas 66210
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Salina Regional Health Center
Salina, Kansas 67401
Contact:
Site Public Contact
785-452-7038
mleepers@srhc.com

University of Kansas Health System Saint Francis Campus
Topeka, Kansas 66606
Contact:
Site Public Contact
785-295-8000

University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Saint Joseph Hospital
Lexington, Kentucky 40504
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky 40504
Contact:
Site Public Contact
859-629-7169
ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Hospital East
Lexington, Kentucky 40509
Contact:
Site Public Contact
859-629-7169
ResearchInstituteInquiries@CommonSpirit.org

University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
Contact:
Site Public Contact
859-257-3379

The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky 40202
Contact:
Site Public Contact
502-562-3429

Louisiana State University Health Science Center
New Orleans, Louisiana 70112
Contact:
Site Public Contact
504-210-3539
emede1@lsuhsc.edu

University Medical Center New Orleans
New Orleans, Louisiana 70112
Contact:
Site Public Contact
504-210-3539
emede1@lsuhsc.edu

MaineHealth Coastal Cancer Treatment Center
Bath, Maine 04530
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
Biddeford, Maine 04005
Contact:
Site Public Contact
LLemire@mmc.org

Lafayette Family Cancer Center-EMMC
Brewer, Maine 04412
Contact:
Site Public Contact
800-987-3005

Maine Medical Center-Bramhall Campus
Portland, Maine 04102
Contact:
Site Public Contact
207-885-7565

MaineHealth Cancer Care Center of York County
Sanford, Maine 04073
Contact:
Site Public Contact
207-459-1600

MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
Sanford, Maine 04073
Contact:
Site Public Contact
LLemire@mmc.org

Maine Medical Center- Scarborough Campus
Scarborough, Maine 04074
Contact:
Site Public Contact
207-396-8090
wrighd@mmc.org

Maine Medical Partners - South Portland
South Portland, Maine 04106
Contact:
Site Public Contact
207-396-8670
ClinicalResearch@mmc.org

Maryland Proton Treatment Center
Baltimore, Maryland 21201
Contact:
Site Public Contact
410-369-5226
info@mdproton.com

University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland 21201
Contact:
Site Public Contact
800-888-8823

UM Upper Chesapeake Medical Center
Bel Air, Maryland 21014
Contact:
Site Public Contact
443-643-3010

Central Maryland Radiation Oncology in Howard County
Columbia, Maryland 21044
Contact:
Site Public Contact
443-546-1300

UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland 21061
Contact:
Site Public Contact
410-553-8100

Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
Contact:
Site Public Contact
800-865-1125

Saint Joseph Mercy Brighton
Brighton, Michigan 48114
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan 48116
Contact:
Site Public Contact
800-865-1125

Henry Ford Cancer Institute-Downriver
Brownstown, Michigan 48183
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Saint Joseph Mercy Canton
Canton, Michigan 48188
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan 48038
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Henry Ford Medical Center-Fairlane
Dearborn, Michigan 48126
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Henry Ford Hospital
Detroit, Michigan 48202
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Ascension Saint John Hospital
Detroit, Michigan 48236
Contact:
Site Public Contact
313-343-3166
karen.forman@ascension.org

Genesys Hurley Cancer Institute
Flint, Michigan 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Hurley Medical Center
Flint, Michigan 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Ascension Providence Hospitals - Novi
Novi, Michigan 48374
Contact:
Site Public Contact
248-849-5332
karen.fife@ascension.org

Henry Ford Medical Center-Columbus
Novi, Michigan 48377
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

21st Century Oncology-Pontiac
Pontiac, Michigan 48341
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Joseph Mercy Oakland
Pontiac, Michigan 48341
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Ascension Providence Hospitals - Southfield
Southfield, Michigan 48075
Contact:
Site Public Contact
248-849-5332
karen.fife@ascension.org

Saint John Macomb-Oakland Hospital
Warren, Michigan 48093
Contact:
Site Public Contact
313-343-3166
karen.forman@ascension.org

Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan 48322
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
Contact:
Site Public Contact
218-333-5000
OncologyClinicalTrialsFargo@sanfordhealth.org

Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi 39705
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

Baptist Cancer Center-Grenada
Grenada, Mississippi 38901
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

Gulfport Memorial Hospital
Gulfport, Mississippi 39502
Contact:
Site Public Contact
504-210-3539
emede1@lsuhsc.edu

Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi 38652
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi 38655
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi 38671
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Contact:
Site Public Contact
573-334-2230
sfmc@sfmc.net

Parkland Health Center - Farmington
Farmington, Missouri 63640
Contact:
Site Public Contact
314-996-5569

Capital Region Southwest Campus
Jefferson City, Missouri 65109
Contact:
Site Public Contact
573-632-4851
amy.franken@health.missouri.edu

University of Kansas Cancer Center - North
Kansas City, Missouri 64154
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri 64064
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri 64116
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Delbert Day Cancer Institute at PCRMC
Rolla, Missouri 65401
Contact:
Site Public Contact
573-458-7504
research@phelpshealth.org

Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri 65401
Contact:
Site Public Contact
573-458-6379

Missouri Baptist Medical Center
Saint Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569

Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Springfield
Springfield, Missouri 65804
Contact:
Site Public Contact
417-269-4520

CoxHealth South Hospital
Springfield, Missouri 65807
Contact:
Site Public Contact
417-269-4520

Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
Contact:
Site Public Contact
314-996-5569

BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri 63127
Contact:
Site Public Contact
314-996-5569

Saint James Community Hospital and Cancer Treatment Center
Butte, Montana 59701
Contact:
Site Public Contact
406-723-2621

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire 03756
Contact:
Site Public Contact
800-639-6918
cancer.research.nurse@dartmouth.edu

University of New Mexico Cancer Center
Albuquerque, New Mexico 87102
Contact:
Site Public Contact
505-925-0348
HSC-ClinicalTrialInfo@salud.unm.edu

Roswell Park Cancer Institute
Buffalo, New York 14263
Contact:
Site Public Contact
800-767-9355
askroswell@roswellpark.org

Glens Falls Hospital
Glens Falls, New York 12801
Contact:
Site Public Contact
518-926-6700

Highland Hospital
Rochester, New York 14620
Contact:
Site Public Contact
585-341-8113

University of Rochester
Rochester, New York 14642
Contact:
Site Public Contact
585-275-5830

Stony Brook University Medical Center
Stony Brook, New York 11794
Contact:
Site Public Contact
800-862-2215

FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina 28374
Contact:
Site Public Contact
910-715-3500
jcwilliams@firsthealth.org

Novant Cancer Institute Radiation Oncology - Supply
Supply, North Carolina 28462
Contact:
Site Public Contact
910-754-4716

Wake Forest Baptist Health - Wilkes Medical Center
Wilkesboro, North Carolina 28659
Contact:
Site Public Contact
888-716-9253

Novant Health Cancer Institute Radiation Oncology - Wilmington
Wilmington, North Carolina 28401
Contact:
Site Public Contact
910-251-1839

Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina 28401
Contact:
Site Public Contact
910-342-3000

Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
Contact:
Site Public Contact
336-713-6771

Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
Contact:
Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Broadway Medical Center
Fargo, North Dakota 58122
Contact:
Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
Contact:
Site Public Contact
701-234-6161
OncologyClinicalTrialsFargo@sanfordhealth.org

Summa Health System - Akron Campus
Akron, Ohio 44304
Contact:
Site Public Contact
330-375-4221
cancerresearch@summahealth.org

UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio 44011
Contact:
Site Public Contact
800-641-2422

Summa Health System - Barberton Campus
Barberton, Ohio 44203
Contact:
Site Public Contact
330-375-4221
cancerresearch@summahealth.org

Dayton Physicians LLC-Miami Valley South
Centerville, Ohio 45459
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Hospital South
Centerville, Ohio 45459
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Case Western Reserve University
Cleveland, Ohio 44106
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

MetroHealth Medical Center
Cleveland, Ohio 44109
Contact:
Site Public Contact
216-778-7559
ababal@metrohealth.org

Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio 44111
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

Cleveland Clinic Foundation
Cleveland, Ohio 44195
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Contact:
Site Public Contact
800-293-5066
Jamesline@osumc.edu

Dayton Blood and Cancer Center
Dayton, Ohio 45409
Contact:
Site Public Contact
937-276-8320

Miami Valley Hospital
Dayton, Ohio 45409
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio 45415
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Hospital North
Dayton, Ohio 45415
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Dayton Physicians LLC-Atrium
Franklin, Ohio 45005
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Cancer Care and Infusion
Greenville, Ohio 45331
Contact:
Site Public Contact
937-569-7515

Cleveland Clinic Cancer Center Mansfield
Mansfield, Ohio 44906
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio 44124
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

Summa Health Medina Medical Center
Medina, Ohio 44256
Contact:
Site Public Contact
330-375-4221
cancerresearch@summahealth.org

UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio 44060
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

University Hospitals Portage Medical Center
Ravenna, Ohio 44266
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

North Coast Cancer Care
Sandusky, Ohio 44870
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio 44136
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

ProMedica Flower Hospital
Sylvania, Ohio 43560
Contact:
Site Public Contact
419-824-1842
PCIOncResearch@promedica.org

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio 43606
Contact:
Site Public Contact
419-824-1842
PCIOncResearch@promedica.org

Upper Valley Medical Center
Troy, Ohio 45373
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio 44691
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

Bryn Mawr Hospital
Bryn Mawr, Pennsylvania 19010
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

Saint Vincent Hospital
Erie, Pennsylvania 16544
Contact:
Site Public Contact
814-452-5000

Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033-0850
Contact:
Site Public Contact
717-531-3779
CTO@hmc.psu.edu

Jefferson Hospital
Jefferson Hills, Pennsylvania 15025
Contact:
Site Public Contact
412-359-3043
ddefazio@wpahs.org

Riddle Memorial Hospital
Media, Pennsylvania 19063
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

Forbes Hospital
Monroeville, Pennsylvania 15146
Contact:
Site Public Contact
412-858-7746

Paoli Memorial Hospital
Paoli, Pennsylvania 19301
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
Contact:
Site Public Contact
215-728-4790

Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
Contact:
Site Public Contact
877-284-2000

Wexford Health and Wellness Pavilion
Wexford, Pennsylvania 15090
Contact:
Site Public Contact
Dawnmarie.DeFazio@ahn.org

Lankenau Medical Center
Wynnewood, Pennsylvania 19096
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

Medical University of South Carolina
Charleston, South Carolina 29425
Contact:
Site Public Contact
843-792-9321
hcc-clinical-trials@musc.edu

Self Regional Healthcare
Greenwood, South Carolina 29646
Contact:
Site Public Contact
864-725-4771
nmcgaha@selfregional.org

Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
Contact:
Site Public Contact
605-312-3320
OncologyClinicTrialsSF@sanfordhealth.org

Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Contact:
Site Public Contact
605-312-3320
OncologyClinicalTrialsSF@SanfordHealth.org

Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee 38017
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee 38120
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas 77030
Contact:
Site Public Contact
713-798-1354
burton@bcm.edu

Michael E DeBakey VA Medical Center
Houston, Texas 77030
Contact:
Site Public Contact
800-553-2278

Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
Contact:
Site Public Contact
888-424-2100
cancerinfo@hci.utah.edu

Norris Cotton Cancer Center-North
Saint Johnsbury, Vermont 05819
Contact:
Site Public Contact
800-639-6918
cancer.research.nurse@hitchcock.org

Inova Alexandria Hospital
Alexandria, Virginia 22304
Contact:
Site Public Contact
703-776-2580
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Inova Schar Cancer Institute
Fairfax, Virginia 22031
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703-720-5210
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Inova Fair Oaks Hospital
Fairfax, Virginia 22033
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FHCC Overlake
Bellevue, Washington 98004
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425-454-2148

Seattle Cancer Care Alliance at EvergreenHealth
Kirkland, Washington 98034
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425-899-6000

FHCC South Lake Union
Seattle, Washington 98109
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800-804-8824

Fred Hutchinson Cancer Research Center
Seattle, Washington 98109
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FHCC at Northwest Hospital
Seattle, Washington 98133
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206-606-5800

University of Washington Medical Center - Montlake
Seattle, Washington 98195
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West Virginia University Charleston Division
Charleston, West Virginia 25304
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304-388-9944

Langlade Hospital and Cancer Center
Antigo, Wisconsin 54409
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715-623-9869
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Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
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800-782-8581
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UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin 53038
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Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
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608-775-2385
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William S Middleton VA Medical Center
Madison, Wisconsin 53705
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University of Wisconsin Carbone Cancer Center
Madison, Wisconsin 53792
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Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
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Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin 53051
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Medical College of Wisconsin
Milwaukee, Wisconsin 53226
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Zablocki Veterans Administration Medical Center
Milwaukee, Wisconsin 53295
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Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin 54548
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ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
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Drexel Town Square Health Center
Oak Creek, Wisconsin 53154
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ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
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Ascension Saint Mary's Hospital
Rhinelander, Wisconsin 54501
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Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
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Ascension Saint Michael's Hospital
Stevens Point, Wisconsin 54481
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Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
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UW Cancer Center at ProHealth Care
Waukesha, Wisconsin 53188
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Aspirus Regional Cancer Center
Wausau, Wisconsin 54401
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Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin 53095
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Marshfield Medical Center - Weston
Weston, Wisconsin 54476
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Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin 54494
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More Details

NCT ID
NCT05050162
Status
Recruiting
Sponsor
NRG Oncology

Detailed Description

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 groups. GROUP I (NON-OROPHARYNGEAL CANCER [OPC]/p16-NEGATIVE OPC): Patients are randomized to 1 of 2 arms. ARM I: 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: 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. GROUP II (p16-POSITIVE OPC/CANCER OF UNKNOWN PRIMARY [CUP]): Patients are randomized to 1 of 2 arms. ARM III: 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 IV Q3W (on days 1, 22, and 43) during radiation therapy in the absence of disease progression or unacceptable toxicity. ARM IV: 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 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.