De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT03952585
Collaborator
NRG Oncology (Other)
711
398
3
67.7
1.8
0

Study Details

Study Description

Brief Summary

This phase II/III trial studies how well a reduced dose of radiation therapy works with nivolumab compared to cisplatin in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer that is early in its growth and may not have spread to other parts of the body (early-stage), and is not associated with smoking. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. 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. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial is being done to see if a reduced dose of radiation therapy and nivolumab works as well as standard dose radiation therapy and cisplatin in treating patients with oropharyngeal cancer.

Detailed Description

PRIMARY OBJECTIVES:
  1. To demonstrate non-inferiority in terms of progression-free survival (PFS) of concurrent reduced-dose radiation therapy (RT) with cisplatin or concurrent reduced-dose radiation therapy with nivolumab to the current standard of care (standard-dose RT with cisplatin). (Phase II) II. To demonstrate co-primary endpoints of non-inferiority of PFS and superiority of quality of life (QOL) as measured by the MD Anderson Dysphagia Inventory (MDADI) of concurrent reduced-dose radiation with cisplatin or concurrent reduced-dose radiation with nivolumab to the current standard of care (standard-dose RT with cisplatin). (Phase III)
SECONDARY OBJECTIVES:
  1. To compare patterns of failure (local and regional relapse versus distant) and overall survival between each experimental arm and the control arm.

  2. To assess long term PFS, overall survival, and toxicity between each experimental arm and the control arm.

  3. To determine acute and late toxicity profiles as measured by the Common Terminology Criteria for Adverse Events (CTCAE).

  4. To explore the symptomatic adverse events (AEs) for tolerability of each treatment arm as measured by the Patient-Reported Outcomes (PRO)-CTCAE.

  5. To compare changes in patient-reported outcomes (Hearing Handicap Inventory for Adults-Screening [HHIA-S], European Organization for Research and Treatment of Cancer [EORTC]-Quality of Life Questionnaire [QLQ]30) between each experimental arm and the control arm.

  6. To assess the association of fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) at baseline with locoregional control and PFS.

  7. To estimate the negative predictive value of the 12-14 weeks post-radiation therapy (RT) FDG-PET/CT in terms of locoregional control rates and PFS rates at 1 and 2 years.

EXPLORATORY OBJECTIVES:
  1. To collect blood and tissue specimens for future translation research. II. To optimize radiotherapy treatment plan quality assurance methodology for radiotherapy planning and imaging.

  2. To compare changes in patient-reported outcomes (European Quality of Life Five Dimension Five Level Scale [EQ-5D-5L]) between each experimental arm and the control arm.

  3. To collect Modified Barium Swallow (MBS) data for future review and analysis.

OUTLINE:

PHASE II: Patients are randomized to 1 of 3 arms.

ARM I: Patients undergo intensity modulated radiation therapy (IMRT) or image-guided radiation therapy (IGRT) over 6 fractions per week and receive cisplatin intravenously (IV) over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo reduced dose IMRT or IGRT once daily (QD) over 5 fractions per week and receive cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.

ARM III: Beginning 1 week prior to radiation, patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks (14 days) for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo reduced dose IMRT or IGRT over 6 fractions per week for 5 weeks in the absence of disease progression or unacceptable toxicity.

PHASE III: Patients are randomized to Arm I, Arm II, and/or Arm III.

After completion of study treatment, patients are followed up at 12-14 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
711 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients With Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer
Actual Study Start Date :
Jul 10, 2019
Anticipated Primary Completion Date :
Feb 28, 2025
Anticipated Study Completion Date :
Feb 28, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm I (IMRT, IGRT, cisplatin)

Patients undergo IMRT or IGRT over 6 fractions per week and receive cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.

Drug: Cisplatin
Given 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
  • Radiation: Image Guided Radiation Therapy
    Undergo IGRT
    Other Names:
  • IGRT
  • image-guided radiation therapy
  • Image-Guided Radiotherapy
  • Radiation: Intensity-Modulated Radiation Therapy
    Undergo IMRT
    Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
  • Radiation, Intensity-Modulated Radiotherapy
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Experimental: Arm II (IMRT, IGRT, cisplatin)

    Patients undergo reduced dose IMRT or IGRT QD over 5 fractions per week and receive cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.

    Drug: Cisplatin
    Given 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
  • Radiation: Image Guided Radiation Therapy
    Undergo IGRT
    Other Names:
  • IGRT
  • image-guided radiation therapy
  • Image-Guided Radiotherapy
  • Radiation: Intensity-Modulated Radiation Therapy
    Undergo IMRT
    Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
  • Radiation, Intensity-Modulated Radiotherapy
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Experimental: Arm III (IMRT, IGRT, nivolumab)

    Beginning 1 week prior to radiation, patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks (14 days) for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo reduced dose IMRT or IGRT over 6 fractions per week for 5 weeks in the absence of disease progression or unacceptable toxicity.

    Radiation: Image Guided Radiation Therapy
    Undergo IGRT
    Other Names:
  • IGRT
  • image-guided radiation therapy
  • Image-Guided Radiotherapy
  • Radiation: Intensity-Modulated Radiation Therapy
    Undergo IMRT
    Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
  • Radiation, Intensity-Modulated Radiotherapy
  • Biological: Nivolumab
    Given IV
    Other Names:
  • BMS-936558
  • CMAB819
  • MDX-1106
  • NIVO
  • Nivolumab Biosimilar CMAB819
  • ONO-4538
  • Opdivo
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival (PFS) (Phase II) [Up to 6 years]

      Will be estimated for all treatment arms using the Kaplan-Meier method (1958). The primary phase IIR endpoint will be tested using a confidence interval (CI) approach.

    2. PFS (Phase III) [Up to 6 years]

      Will be estimated for all treatment arms using the Kaplan-Meier method (1958). The co-primary phase III endpoint will be tested using a confidence interval (CI) approach.

    3. Quality of life [Baseline up to 6 years]

      Measured by the MD Anderson Dysphagia Inventory (MDADI) global quality of life (QOL) score. Will be compared between arms using a two-sample independent t-test at a one-sided significance level of 0.05 for each experimental arm comparison. MDADI global score and change from baseline will be summarized using mean and standard deviation at each time point for each arm.

    Secondary Outcome Measures

    1. Locoregional failure [From the time of randomization to the date of failure, date of precluding event, or last known follow-up date, assessed up to 6 years]

      The cumulative incidence estimator will be used to estimate time to event distributions for locoregional failure between arm differences tested using cause-specific log-rank test.

    2. Distant failure [Up to 6 years]

    3. Overall survival [From the date of randomization to the date of death or last known follow-up date, with patients alive at the last known follow-up time treated as censored, assessed up to 6 years]

      Will be estimated using the Kaplan-Meier method and treatment arms compared using the log-rank test (Kaplan 1958).

    4. Incidence of adverse events [Up to 6 years]

      Measured by the Common Terminology Criteria for Adverse Events (CTCAE). Adverse events (AEs) will be graded using CTCAE version (v)5.0. Counts of all AEs by grade will be provided by treatment arm. Counts and frequencies will be provided for the worst grade AE experienced by the patient by treatment arm. The number of patients with at least 1 grade 3 or higher AE will be compared between the treatment arms. A comparison between treatment arms of grade 3 and higher AEs related to treatment will also be tested. A comparison of grade 3 and higher events will be compared between treatment arms. All comparisons will be tested using a Chi-Square test, or Fisher's exact test if cell frequencies are < 5, with a significance level of 0.05.

    5. Hearing [Baseline up to 24 months from end of radiation therapy (RT)]

      Measured as Hearing Handicap Inventory for Adults-Screening (HHIA-S).

    6. Quality of life [Baseline up to 24 months from end of RT]

      Measured by the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire (QLQ)30.

    7. Fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) locoregional control [Up to 6 years]

      Will be associated with PFS.

    8. Negative predictive value of post-RT FDG-PET/CT for locoregional control [At 1 and 2 years]

      The negative predictive value of FDG-PET/CT for locoregional control will be estimated using binomial proportions and confidence intervals based on normal approximation.

    9. Negative predictive value of post-RT FDG-PET/CT for PFS [At 1 and 2 years]

      The negative predictive value of FDG-PET/CT PFS will be estimated using binomial proportions and confidence intervals based on normal approximation.

    10. Incidence of adverse events [Up to 6 years]

      Measured using Patient-Reported Outcomes (PRO)-CTCAE. For each symptom, counts and frequencies will be provided for the worst score experienced by the patient by treatment arm. The proportion of patients with scores >= 1 and >= 3 will be compared between groups using a Chi-square test, or Fisher's exact test if cell frequencies are < 5, using a significance level of 0.05. Analysis of changes in patient reported outcomes over time will analyzed by fitting generalized estimating equations (GEE) models using a logit link (dichotomizing the symptom scores as 0 vs. > 1 and 0-2 vs. 3-4) with time of assessment, treatment arm, and treatment-by-time interaction terms in the model.

    Other Outcome Measures

    1. Quality of life [Baseline up to 24 months from end of RT]

      Measured by EuroQol-5 Dimensional- 5 Level (EQ-5D-5L).

    2. Swallowing physiology [Up to 6 years]

      Measured by a Modified Barium Swallow (MBS) test. The proportion of aspiration for each arm will be estimated assuming a binomial distribution and between arm comparison will be performed using a Fisher's exact test.

    3. Locoregional control for patients with post-RT FDG-PET/CT [At 12-14 weeks post-RT]

      Locoregional control rates will be compared between negative and positive/undetermined patients. Cox proportional hazards models will be used to determine whether there are differences between these two groups, while adjusting for treatment arm and other covariates (cause-specific Cox models for locoregional failure).

    4. PFS for patients with post-RT FDG-PET/CT [At 12-14 weeks post-RT]

      PFS rates will be compared between negative and positive/undetermined patients. Cox proportional hazards models will be used to determine whether there are differences between these two groups, while adjusting for treatment arm and other covariates (cause-specific Cox models for locoregional failure).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma but not neuroendocrine phenotype) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage)

    • 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

    • P16-positive based on local site immunohistochemical tissue staining (defined as greater than 70% strong diffuse nuclear or nuclear and cytoplasmic staining of tumor cells). Fine needle aspiration (FNA) biopsy specimens may be used as the sole diagnostic tissue. Centers are encouraged to contact the pathology chair for clarification

    • Note: Institutions must screen patients, whose tumors must be p16-positive 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-positive results must be reported on the pathology report being submitted

    • Clinical stage T1-2, N1, M0 (American Joint Committee on Cancer [AJCC], 8th edition [ed.]) or T3, N0-N1, M0 (AJCC, 8th ed.) including no distant metastases based on the following diagnostic workup:

    • General history and physical examination within 56 days prior to registration;

    • Exam with laryngopharyngoscopy (mirror or in office direct procedure acceptable) within 70 days prior to registration;

    • One of the following imaging studies is required within 56 days prior to registration:

    • FDG-PET/CT of the neck and chest (with or without contrast); FDG-PET/CT scan is strongly preferred and highly recommended to be used for eligibility OR

    • Chest CT (with or without contrast)

    • One of the following imaging studies is required within 28 days prior to registration:

    • A diagnostic CT scan of neck (with contrast and of diagnostic quality) OR

    • An magnetic resonance imaging (MRI) of the neck (with contrast and of diagnostic quality)

    • 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

    • Patients must provide their personal smoking history prior to registration. The lifetime cumulative history cannot exceed 10 pack-years. The following formula is used to calculate the pack-years during the periods of smoking in the patient's life; the cumulative total of the number of pack-years during each period of active smoking is the lifetime cumulative history

    • Number of pack-years = [Frequency of smoking (number of cigarettes per day) x duration of cigarette smoking (years)] / 20

    • Note: Twenty cigarettes is considered equivalent to one pack. The effect of non-cigarette tobacco products on the survival of patients with p16-positive oropharyngeal cancers is undefined. While there are reportedly increased risks of head and neck cancer associated with sustained heavy cigar and pipe use (Wyss 2013), such sustained use of non-cigarette products is unusual and does not appear to convey added risk with synchronous cigarette smoking. Cigar and pipe tobacco consumption is therefore not included in calculating the lifetime pack-years. Marijuana consumption is likewise not considered in this calculation. There is no clear scientific evidence regarding the role of chewing tobacco-containing products in this disease, although this is possibly more concerning given the proximity of the oral cavity and oropharynx. In any case, investigators are discouraged from enrolling patients with a history of very sustained use (such as several years or more) of non-cigarette tobacco products alone

    • Zubrod performance status of 0-1 within 14 days prior to registration

    • Absolute neutrophil count >= 1,500/mcL (within 14 days prior to registration)

    • Platelets >= 100,000/mcL (within 14 days prior to registration)

    • Hemoglobin >= 8.0 g/dL (within 14 days prior to registration) (Note: use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dL is acceptable)

    • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 14 days prior to registration)

    • Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional ULN (within 14 days prior to registration)

    • Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula) (within 14 days prior to registration)

    • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

    • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

    • Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B)

    • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment for the hepatitis, they are eligible if they have an undetectable HCV viral load.

    • Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy

    • For women of childbearing potential (WOCBP), negative serum or urine pregnancy test within 24 hours prior to registration

    • Women of childbearing potential (WOCBP) is defined as any female 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. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL

    • Women of childbearing potential (WOCBP) and men who are sexually active with WOCBP must be willing to use an adequate method of contraception during and after treatment

    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

    • Only English, Spanish, or French speaking patients are eligible to participate as these are the only languages for which the mandatory dysphagia-related patient reported instrument (MDADI) is available

    Exclusion Criteria:
    • Clinical stages T0; T4; T1-2, N0; or any N2 (AJCC, 8th ed)

    • Recurrent disease

    • Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles

    • Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16-positive, or histologies of adenosquamous, verrucous, or spindle cell carcinomas

    • Carcinoma of the neck of unknown primary site origin (T0 is ineligible, even if p16-positive)

    • Radiographically matted nodes, defined as 3 abutting nodes with loss of the intervening fat plane

    • Supraclavicular nodes, defined as nodes centered below the level of the cricoid cartilage

    • Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed

    • Patients with simultaneous primary cancers or separate bilateral primary tumor sites are excluded with the exception of patients with bilateral tonsil cancers

    • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (of note, the exclusion applies only for invasive cancers such that carcinoma in situ of the breast, oral cavity, or cervix are all permissible)

    • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable

    • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

    • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways

    • History of severe hypersensitivity reaction to any monoclonal antibody.

    • Severe, active co-morbidity defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

    • Transmural myocardial infarction within the last 6 months

    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration

    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration

    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

    • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition with immune compromise greater than that noted; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients

    • Condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration. Inhaled or topical steroids and adrenal replacement doses < 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease

    • Patients with active autoimmune disease requiring systemic treatment (i.e. disease modifying agents, corticosteroids, or immunosuppressive drugs) should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), rheumatoid arthritis, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease

    • Note: Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)

    • Patients who are pregnant, nursing, or expecting to conceive or father children

    • Prior allergic reaction to cisplatin

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Cancer Center Birmingham Alabama United States 35233
    2 Banner MD Anderson Cancer Center Gilbert Arizona United States 85234
    3 Banner University Medical Center - Tucson Tucson Arizona United States 85719
    4 University of Arizona Cancer Center-North Campus Tucson Arizona United States 85719
    5 Sutter Auburn Faith Hospital Auburn California United States 95602
    6 Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California United States 95603
    7 Tower Cancer Research Foundation Beverly Hills California United States 90211
    8 Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California United States 95682
    9 City of Hope Comprehensive Cancer Center Duarte California United States 91010
    10 UC San Diego Moores Cancer Center La Jolla California United States 92093
    11 City of Hope Antelope Valley Lancaster California United States 93534
    12 Los Angeles County-USC Medical Center Los Angeles California United States 90033
    13 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033
    14 Cedars Sinai Medical Center Los Angeles California United States 90048
    15 Fremont - Rideout Cancer Center Marysville California United States 95901
    16 Stanford Cancer Institute Palo Alto Palo Alto California United States 94304
    17 Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California United States 95661
    18 Sutter Roseville Medical Center Roseville California United States 95661
    19 Sutter Medical Center Sacramento Sacramento California United States 95816
    20 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    21 Naval Medical Center -San Diego San Diego California United States 92134
    22 UCSF Medical Center-Mission Bay San Francisco California United States 94158
    23 City of Hope South Pasadena South Pasadena California United States 91030
    24 Torrance Memorial Physician Network - Cancer Care Torrance California United States 90505
    25 Torrance Memorial Medical Center Torrance California United States 90509
    26 City of Hope Upland Upland California United States 91786
    27 Rocky Mountain Regional VA Medical Center Aurora Colorado United States 80045
    28 University of Colorado Hospital Aurora Colorado United States 80045
    29 Rocky Mountain Cancer Centers-Boulder Boulder Colorado United States 80304
    30 Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado United States 80907
    31 UCHealth Memorial Hospital Central Colorado Springs Colorado United States 80909
    32 Memorial Hospital North Colorado Springs Colorado United States 80920
    33 Porter Adventist Hospital Denver Colorado United States 80210
    34 Poudre Valley Hospital Fort Collins Colorado United States 80524
    35 Cancer Care and Hematology-Fort Collins Fort Collins Colorado United States 80528
    36 UCHealth Greeley Hospital Greeley Colorado United States 80631
    37 Littleton Adventist Hospital Littleton Colorado United States 80122
    38 Medical Center of the Rockies Loveland Colorado United States 80538
    39 Parker Adventist Hospital Parker Colorado United States 80138
    40 Delaware Clinical and Laboratory Physicians PA Newark Delaware United States 19713
    41 Helen F Graham Cancer Center Newark Delaware United States 19713
    42 Medical Oncology Hematology Consultants PA Newark Delaware United States 19713
    43 Christiana Care Health System-Christiana Hospital Newark Delaware United States 19718
    44 UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables Florida United States 33146
    45 UM Sylvester Comprehensive Cancer Center at Coral Springs Coral Springs Florida United States 33065
    46 UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida United States 33442
    47 University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida United States 33136
    48 Miami Cancer Institute Miami Florida United States 33176
    49 Orlando Health Cancer Institute Orlando Florida United States 32806
    50 Moffitt Cancer Center-International Plaza Tampa Florida United States 33607
    51 Moffitt Cancer Center - McKinley Campus Tampa Florida United States 33612
    52 Moffitt Cancer Center Tampa Florida United States 33612
    53 Moffitt Cancer Center at Wesley Chapel Wesley Chapel Florida United States 33544
    54 Grady Health System Atlanta Georgia United States 30303
    55 Emory University Hospital Midtown Atlanta Georgia United States 30308
    56 Hawaii Cancer Care - Savio 'Aiea Hawaii United States 96701
    57 Pali Momi Medical Center 'Aiea Hawaii United States 96701
    58 Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii United States 96813
    59 Queen's Cancer Cenrer - POB I Honolulu Hawaii United States 96813
    60 Queen's Medical Center Honolulu Hawaii United States 96813
    61 Straub Clinic and Hospital Honolulu Hawaii United States 96813
    62 University of Hawaii Cancer Center Honolulu Hawaii United States 96813
    63 Hawaii Cancer Care Inc-Liliha Honolulu Hawaii United States 96817
    64 Kuakini Medical Center Honolulu Hawaii United States 96817
    65 Queen's Cancer Center - Kuakini Honolulu Hawaii United States 96817
    66 The Cancer Center of Hawaii-Liliha Honolulu Hawaii United States 96817
    67 Kapiolani Medical Center for Women and Children Honolulu Hawaii United States 96826
    68 Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii United States 96766
    69 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
    70 Saint Luke's Cancer Institute - Boise Boise Idaho United States 83712
    71 Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho United States 83605
    72 Saint Luke's Cancer Institute - Fruitland Fruitland Idaho United States 83619
    73 Saint Luke's Cancer Institute - Meridian Meridian Idaho United States 83642
    74 Saint Alphonsus Medical Center-Nampa Nampa Idaho United States 83686
    75 Saint Luke's Cancer Institute - Nampa Nampa Idaho United States 83686
    76 Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho United States 83301
    77 Rush - Copley Medical Center Aurora Illinois United States 60504
    78 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
    79 Illinois CancerCare-Canton Canton Illinois United States 61520
    80 Illinois CancerCare-Carthage Carthage Illinois United States 62321
    81 Centralia Oncology Clinic Centralia Illinois United States 62801
    82 Northwestern University Chicago Illinois United States 60611
    83 Rush University Medical Center Chicago Illinois United States 60612
    84 Cancer Care Specialists of Illinois - Decatur Decatur Illinois United States 62526
    85 Decatur Memorial Hospital Decatur Illinois United States 62526
    86 Crossroads Cancer Center Effingham Illinois United States 62401
    87 Illinois CancerCare-Eureka Eureka Illinois United States 61530
    88 NorthShore University HealthSystem-Evanston Hospital Evanston Illinois United States 60201
    89 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
    90 Western Illinois Cancer Treatment Center Galesburg Illinois United States 61401
    91 NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois United States 60026
    92 NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois United States 60035
    93 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
    94 Illinois CancerCare-Macomb Macomb Illinois United States 61455
    95 Loyola University Medical Center Maywood Illinois United States 60153
    96 Cancer Care Center of O'Fallon O'Fallon Illinois United States 62269
    97 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    98 Illinois CancerCare-Pekin Pekin Illinois United States 61554
    99 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    100 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    101 OSF Saint Francis Medical Center Peoria Illinois United States 61637
    102 Illinois CancerCare-Peru Peru Illinois United States 61354
    103 Illinois CancerCare-Princeton Princeton Illinois United States 61356
    104 SwedishAmerican Regional Cancer Center/ACT Rockford Illinois United States 61114
    105 Memorial Hospital East Shiloh Illinois United States 62269
    106 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    107 Springfield Clinic Springfield Illinois United States 62702
    108 Memorial Medical Center Springfield Illinois United States 62781
    109 Illinois CancerCare - Washington Washington Illinois United States 61571
    110 IU Health North Hospital Carmel Indiana United States 46032
    111 Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana United States 46202
    112 Sidney and Lois Eskenazi Hospital Indianapolis Indiana United States 46202
    113 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa United States 50325
    114 Mercy Cancer Center-West Lakes Clive Iowa United States 50325
    115 Greater Regional Medical Center Creston Iowa United States 50801
    116 Iowa Methodist Medical Center Des Moines Iowa United States 50309
    117 Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa United States 50309
    118 Broadlawns Medical Center Des Moines Iowa United States 50314
    119 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
    120 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    121 Iowa Lutheran Hospital Des Moines Iowa United States 50316
    122 Methodist West Hospital West Des Moines Iowa United States 50266-7700
    123 Mercy Medical Center-West Lakes West Des Moines Iowa United States 50266
    124 University of Kansas Cancer Center Kansas City Kansas United States 66160
    125 Lawrence Memorial Hospital Lawrence Kansas United States 66044
    126 University of Kansas Cancer Center-Overland Park Overland Park Kansas United States 66210
    127 Salina Regional Health Center Salina Kansas United States 67401
    128 University of Kansas Health System Saint Francis Campus Topeka Kansas United States 66606
    129 University of Kansas Hospital-Westwood Cancer Center Westwood Kansas United States 66205
    130 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
    131 Jewish Hospital Louisville Kentucky United States 40202
    132 Norton Hospital Pavilion and Medical Campus Louisville Kentucky United States 40202
    133 The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky United States 40202
    134 Norton Brownsboro Hospital and Medical Campus Louisville Kentucky United States 40241
    135 LSU Health Baton Rouge-North Clinic Baton Rouge Louisiana United States 70805
    136 Louisiana Hematology Oncology Associates LLC Baton Rouge Louisiana United States 70809
    137 Mary Bird Perkins Cancer Center Baton Rouge Louisiana United States 70809
    138 Our Lady of the Lake Physicians Group - Medical Oncology Baton Rouge Louisiana United States 70809
    139 East Jefferson General Hospital Metairie Louisiana United States 70006
    140 MaineHealth Coastal Cancer Treatment Center Bath Maine United States 04530
    141 MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford Biddeford Maine United States 04005
    142 Maine Medical Center-Bramhall Campus Portland Maine United States 04102
    143 Penobscot Bay Medical Center Rockport Maine United States 04856
    144 MaineHealth Cancer Care Center of York County Sanford Maine United States 04073
    145 MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford Sanford Maine United States 04073
    146 Maine Medical Center- Scarborough Campus Scarborough Maine United States 04074
    147 Maine Medical Partners - South Portland South Portland Maine United States 04106
    148 University of Maryland/Greenebaum Cancer Center Baltimore Maryland United States 21201
    149 Greater Baltimore Medical Center Baltimore Maryland United States 21204
    150 UM Upper Chesapeake Medical Center Bel Air Maryland United States 21014
    151 Boston Medical Center Boston Massachusetts United States 02118
    152 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    153 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    154 McLaren Cancer Institute-Bay City Bay City Michigan United States 48706
    155 Saint Joseph Mercy Brighton Brighton Michigan United States 48114
    156 Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan United States 48114
    157 Henry Ford Cancer Institute-Downriver Brownstown Michigan United States 48183
    158 Saint Joseph Mercy Canton Canton Michigan United States 48188
    159 Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan United States 48188
    160 Caro Cancer Center Caro Michigan United States 48723
    161 Saint Joseph Mercy Chelsea Chelsea Michigan United States 48118
    162 Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan United States 48118
    163 McLaren Cancer Institute-Clarkston Clarkston Michigan United States 48346
    164 Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan United States 48038
    165 Henry Ford Medical Center-Fairlane Dearborn Michigan United States 48126
    166 Wayne State University/Karmanos Cancer Institute Detroit Michigan United States 48201
    167 Henry Ford Hospital Detroit Michigan United States 48202
    168 Weisberg Cancer Treatment Center Farmington Hills Michigan United States 48334
    169 McLaren Cancer Institute-Flint Flint Michigan United States 48532
    170 Singh and Arora Hematology Oncology PC Flint Michigan United States 48532
    171 Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan United States 49503
    172 Mercy Health Saint Mary's Grand Rapids Michigan United States 49503
    173 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
    174 Karmanos Cancer Institute at McLaren Greater Lansing Lansing Michigan United States 48910
    175 Mid-Michigan Physicians-Lansing Lansing Michigan United States 48912
    176 Sparrow Hospital Lansing Michigan United States 48912
    177 McLaren Cancer Institute-Lapeer Region Lapeer Michigan United States 48446
    178 Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan United States 48154
    179 Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan United States 48453
    180 McLaren Cancer Institute-Macomb Mount Clemens Michigan United States 48043
    181 Lakeland Hospital Niles Niles Michigan United States 49120
    182 Henry Ford Medical Center-Columbus Novi Michigan United States 48377
    183 McLaren Cancer Institute-Northern Michigan Petoskey Michigan United States 49770
    184 McLaren-Port Huron Port Huron Michigan United States 48060
    185 Ascension Saint Mary's Hospital Saginaw Michigan United States 48601
    186 Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan United States 48604
    187 Lakeland Medical Center Saint Joseph Saint Joseph Michigan United States 49085
    188 Marie Yeager Cancer Center Saint Joseph Michigan United States 49085
    189 Henry Ford Macomb Health Center - Shelby Township Shelby Michigan United States 48315
    190 Ascension Saint Joseph Hospital Tawas City Michigan United States 48764
    191 Henry Ford West Bloomfield Hospital West Bloomfield Michigan United States 48322
    192 Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan United States 48661
    193 Metro Health Hospital Wyoming Michigan United States 49519
    194 Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan United States 48197
    195 Sanford Joe Lueken Cancer Center Bemidji Minnesota United States 56601
    196 Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota United States 56303
    197 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    198 Siteman Cancer Center at West County Hospital Creve Coeur Missouri United States 63141
    199 Parkland Health Center - Farmington Farmington Missouri United States 63640
    200 Freeman Health System Joplin Missouri United States 64804
    201 University of Kansas Cancer Center - North Kansas City Missouri United States 64154
    202 University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri United States 64064
    203 Delbert Day Cancer Institute at PCRMC Rolla Missouri United States 65401
    204 Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri United States 65401
    205 Washington University School of Medicine Saint Louis Missouri United States 63110
    206 Siteman Cancer Center-South County Saint Louis Missouri United States 63129
    207 Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri United States 63376
    208 Mercy Hospital Springfield Springfield Missouri United States 65804
    209 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    210 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    211 CHI Health Good Samaritan Kearney Nebraska United States 68847
    212 University of Nebraska Medical Center Omaha Nebraska United States 68198
    213 Renown Regional Medical Center Reno Nevada United States 89502
    214 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08903
    215 Community Medical Center Toms River New Jersey United States 08755
    216 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
    217 New Mexico Oncology Hematology Consultants Albuquerque New Mexico United States 87109
    218 Noyes Memorial Hospital/Myers Cancer Center Dansville New York United States 14437
    219 Upstate Cancer Center at Oswego Oswego New York United States 13126
    220 Highland Hospital Rochester New York United States 14620
    221 University of Rochester Rochester New York United States 14642
    222 Stony Brook University Medical Center Stony Brook New York United States 11794
    223 State University of New York Upstate Medical University Syracuse New York United States 13210
    224 Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina United States 28203
    225 Novant Health Presbyterian Medical Center Charlotte North Carolina United States 28204
    226 Atrium Health Pineville/LCI-Pineville Charlotte North Carolina United States 28210
    227 Atrium Health University City/LCI-University Charlotte North Carolina United States 28262
    228 Levine Cancer Institute-Ballantyne Charlotte North Carolina United States 28277
    229 Wake Forest University at Clemmons Clemmons North Carolina United States 27012
    230 Atrium Health Cabarrus/LCI-Concord Concord North Carolina United States 28025
    231 CaroMont Regional Medical Center Gastonia North Carolina United States 28054
    232 Novant Health Cancer Institute - Kernersville Kernersville North Carolina United States 27284
    233 Atrium Health Union/LCI-Union Monroe North Carolina United States 28112
    234 Novant Health Cancer Institute - Mount Airy Mount Airy North Carolina United States 27030
    235 FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst North Carolina United States 28374
    236 Novant Health Cancer Institute - Statesville Statesville North Carolina United States 28625
    237 Wake Forest Baptist Health - Hematology Oncology - Statesville Statesville North Carolina United States 28677
    238 Novant Health Cancer Institute - Thomasville Thomasville North Carolina United States 27360
    239 Novant Health Cancer Institute - Wilkesboro Wilkesboro North Carolina United States 28659
    240 Wake Forest Baptist Health - Wilkes Medical Center Wilkesboro North Carolina United States 28659
    241 Novant Health Forsyth Medical Center Winston-Salem North Carolina United States 27103
    242 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    243 Sanford Bismarck Medical Center Bismarck North Dakota United States 58501
    244 Sanford Broadway Medical Center Fargo North Dakota United States 58122
    245 Sanford Roger Maris Cancer Center Fargo North Dakota United States 58122
    246 Summa Health System - Akron Campus Akron Ohio United States 44304
    247 Summa Health System - Barberton Campus Barberton Ohio United States 44203
    248 Geauga Hospital Chardon Ohio United States 44024
    249 University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio United States 45219
    250 Case Western Reserve University Cleveland Ohio United States 44106
    251 MetroHealth Medical Center Cleveland Ohio United States 44109
    252 Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio United States 44111
    253 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    254 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    255 Cleveland Clinic Cancer Center Mansfield Mansfield Ohio United States 44906
    256 Hillcrest Hospital Cancer Center Mayfield Heights Ohio United States 44124
    257 Summa Health Medina Medical Center Medina Ohio United States 44256
    258 UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio United States 44060
    259 UH Seidman Cancer Center at Southwest General Hospital Middleburg Heights Ohio United States 44130
    260 Mercy Health Perrysburg Cancer Center Perrysburg Ohio United States 43551
    261 North Coast Cancer Care Sandusky Ohio United States 44870
    262 Cleveland Clinic Cancer Center Strongsville Strongsville Ohio United States 44136
    263 ProMedica Flower Hospital Sylvania Ohio United States 43560
    264 Saint Vincent Mercy Medical Center Toledo Ohio United States 43608
    265 Mercy Health - Saint Anne Hospital Toledo Ohio United States 43623
    266 University of Cincinnati Cancer Center-West Chester West Chester Ohio United States 45069
    267 UH Seidman Cancer Center at Saint John Medical Center Westlake Ohio United States 44145
    268 UHHS-Westlake Medical Center Westlake Ohio United States 44145
    269 Cleveland Clinic Wooster Family Health and Surgery Center Wooster Ohio United States 44691
    270 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    271 Clackamas Radiation Oncology Center Clackamas Oregon United States 97015
    272 Providence Cancer Institute Clackamas Clinic Clackamas Oregon United States 97015
    273 Providence Newberg Medical Center Newberg Oregon United States 97132
    274 Providence Portland Medical Center Portland Oregon United States 97213
    275 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    276 Kaiser Permanente Northwest Portland Oregon United States 97227
    277 Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania United States 18103
    278 UPMC Altoona Altoona Pennsylvania United States 16601
    279 UPMC-Heritage Valley Health System Beaver Beaver Pennsylvania United States 15009
    280 Carlisle Regional Cancer Center Carlisle Pennsylvania United States 17015
    281 Christiana Care Health System-Concord Health Center Chadds Ford Pennsylvania United States 19317
    282 Geisinger Medical Center Danville Pennsylvania United States 17822
    283 Fox Chase Cancer Center - East Norriton Hospital Outpatient Center East Norriton Pennsylvania United States 19401
    284 Ephrata Cancer Center Ephrata Pennsylvania United States 17522
    285 UPMC Hillman Cancer Center Erie Erie Pennsylvania United States 16505
    286 UPMC Cancer Center at UPMC Horizon Farrell Pennsylvania United States 16121
    287 Fox Chase Cancer Center Buckingham Furlong Pennsylvania United States 18925
    288 Adams Cancer Center Gettysburg Pennsylvania United States 17325
    289 UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg Pennsylvania United States 15601
    290 UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg Pennsylvania United States 17109
    291 Penn State Milton S Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    292 UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown Pennsylvania United States 15901
    293 Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania United States 17837
    294 Lewistown Hospital Lewistown Pennsylvania United States 17044
    295 UPMC Cancer Center at UPMC McKeesport McKeesport Pennsylvania United States 15132
    296 UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg Pennsylvania United States 17050
    297 Forbes Hospital Monroeville Pennsylvania United States 15146
    298 UPMC Cancer Center - Monroeville Monroeville Pennsylvania United States 15146
    299 UPMC-Coraopolis/Heritage Valley Radiation Oncology Moon Pennsylvania United States 15108
    300 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
    301 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    302 Jefferson Torresdale Hospital Philadelphia Pennsylvania United States 19114
    303 Temple University Hospital Philadelphia Pennsylvania United States 19140
    304 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
    305 UPMC-Magee Womens Hospital Pittsburgh Pennsylvania United States 15213
    306 UPMC-Saint Margaret Pittsburgh Pennsylvania United States 15215
    307 UPMC-Shadyside Hospital Pittsburgh Pennsylvania United States 15232
    308 UPMC-Passavant Hospital Pittsburgh Pennsylvania United States 15237
    309 UPMC-Saint Clair Hospital Cancer Center Pittsburgh Pennsylvania United States 15243
    310 Geisinger Cancer Services-Pottsville Pottsville Pennsylvania United States 17901
    311 UPMC Cancer Center at UPMC Northwest Seneca Pennsylvania United States 16346
    312 UPMC Uniontown Hospital Radiation Oncology Uniontown Pennsylvania United States 15401
    313 UPMC Washington Hospital Radiation Oncology Washington Pennsylvania United States 15301
    314 Reading Hospital West Reading Pennsylvania United States 19611
    315 Wexford Health and Wellness Pavilion Wexford Pennsylvania United States 15090
    316 Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania United States 18711
    317 WellSpan Health-York Cancer Center York Pennsylvania United States 17403
    318 WellSpan Health-York Hospital York Pennsylvania United States 17403
    319 UPMC Memorial York Pennsylvania United States 17408
    320 Medical University of South Carolina Charleston South Carolina United States 29425
    321 Gibbs Cancer Center-Gaffney Gaffney South Carolina United States 29341
    322 Tidelands Georgetown Memorial Hospital Georgetown South Carolina United States 29440
    323 Saint Francis Hospital Greenville South Carolina United States 29601
    324 Prisma Health Cancer Institute - Faris Greenville South Carolina United States 29605
    325 Saint Francis Cancer Center Greenville South Carolina United States 29607
    326 Prisma Health Cancer Institute - Eastside Greenville South Carolina United States 29615
    327 Prisma Health Cancer Institute - Greer Greer South Carolina United States 29650
    328 Gibbs Cancer Center-Pelham Greer South Carolina United States 29651
    329 Rock Hill Radiation Therapy Center Rock Hill South Carolina United States 29730
    330 Levine Cancer Institute-Rock Hill Rock Hill South Carolina United States 29732
    331 Prisma Health Cancer Institute - Seneca Seneca South Carolina United States 29672
    332 Spartanburg Medical Center Spartanburg South Carolina United States 29303
    333 MGC Hematology Oncology-Union Union South Carolina United States 29379
    334 Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota United States 57104
    335 Avera Cancer Institute Sioux Falls South Dakota United States 57105
    336 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    337 The West Clinic - Wolf River Germantown Tennessee United States 38138
    338 University of Tennessee - Knoxville Knoxville Tennessee United States 37920
    339 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
    340 The Don and Sybil Harrington Cancer Center Amarillo Texas United States 79106
    341 American Fork Hospital / Huntsman Intermountain Cancer Center American Fork Utah United States 84003
    342 Farmington Health Center Farmington Utah United States 84025
    343 Logan Regional Hospital Logan Utah United States 84321
    344 Intermountain Medical Center Murray Utah United States 84107
    345 McKay-Dee Hospital Center Ogden Utah United States 84403
    346 Utah Valley Regional Medical Center Provo Utah United States 84604
    347 Riverton Hospital Riverton Utah United States 84065
    348 Saint George Regional Medical Center Saint George Utah United States 84770
    349 Utah Cancer Specialists-Salt Lake City Salt Lake City Utah United States 84106
    350 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
    351 LDS Hospital Salt Lake City Utah United States 84143
    352 Inova Schar Cancer Institute Fairfax Virginia United States 22031
    353 Inova Fair Oaks Hospital Fairfax Virginia United States 22033
    354 Naval Medical Center - Portsmouth Portsmouth Virginia United States 23708-2197
    355 VCU Massey Cancer Center at Stony Point Richmond Virginia United States 23235
    356 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298
    357 Swedish Medical Center-Ballard Campus Seattle Washington United States 98107
    358 Swedish Medical Center-First Hill Seattle Washington United States 98122-4307
    359 Langlade Hospital and Cancer Center Antigo Wisconsin United States 54409
    360 Ascension Saint Elizabeth Hospital Appleton Wisconsin United States 54915
    361 Ascension Southeast Wisconsin Hospital - Elmbrook Campus Brookfield Wisconsin United States 53045
    362 Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin United States 53105
    363 Ascension Calumet Hospital Chilton Wisconsin United States 53014
    364 HSHS Sacred Heart Hospital Eau Claire Wisconsin United States 54701
    365 Ascension Saint Francis - Reiman Cancer Center Franklin Wisconsin United States 53132
    366 Ascension Southeast Wisconsin Hospital - Franklin Franklin Wisconsin United States 53132
    367 Aurora Health Care Germantown Health Center Germantown Wisconsin United States 53022
    368 Aurora Cancer Care-Grafton Grafton Wisconsin United States 53024
    369 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin United States 54301
    370 Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin United States 54303
    371 Aurora BayCare Medical Center Green Bay Wisconsin United States 54311
    372 UW Cancer Center Johnson Creek Johnson Creek Wisconsin United States 53038
    373 Aurora Cancer Care-Kenosha South Kenosha Wisconsin United States 53142
    374 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
    375 University of Wisconsin Carbone Cancer Center Madison Wisconsin United States 53792
    376 Aurora Bay Area Medical Group-Marinette Marinette Wisconsin United States 54143
    377 Froedtert Menomonee Falls Hospital Menomonee Falls Wisconsin United States 53051
    378 Ascension Columbia Saint Mary's Hospital Ozaukee Mequon Wisconsin United States 53097
    379 Aurora Cancer Care-Milwaukee Milwaukee Wisconsin United States 53209
    380 Ascension Southeast Wisconsin Hospital - Saint Joseph Campus Milwaukee Wisconsin United States 53210
    381 Ascension Columbia Saint Mary's Hospital - Milwaukee Milwaukee Wisconsin United States 53211
    382 Ascension Saint Francis Hospital Milwaukee Wisconsin United States 53215
    383 Aurora Saint Luke's Medical Center Milwaukee Wisconsin United States 53215
    384 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    385 Aurora Sinai Medical Center Milwaukee Wisconsin United States 53233
    386 Ascension Mercy Hospital Oshkosh Wisconsin United States 54904
    387 Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin United States 54904
    388 Ascension All Saints Hospital Racine Wisconsin United States 53405
    389 Aurora Cancer Care-Racine Racine Wisconsin United States 53406
    390 Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin United States 53081
    391 Aurora Medical Center in Summit Summit Wisconsin United States 53066
    392 Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin United States 54241
    393 Aspirus Regional Cancer Center Wausau Wisconsin United States 54401
    394 Ascension Medical Group Southeast Wisconsin - Mayfair Road Wauwatosa Wisconsin United States 53226
    395 Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin United States 53226
    396 Aurora West Allis Medical Center West Allis Wisconsin United States 53227
    397 Froedtert West Bend Hospital/Kraemer Cancer Center West Bend Wisconsin United States 53095
    398 Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin United States 54494

    Sponsors and Collaborators

    • National Cancer Institute (NCI)
    • NRG Oncology

    Investigators

    • Principal Investigator: Sue S Yom, NRG Oncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT03952585
    Other Study ID Numbers:
    • NCI-2019-03015
    • NCI-2019-03015
    • NRG-HN005
    • NRG-HN005
    • U10CA180868
    First Posted:
    May 16, 2019
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 19, 2022