Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT02466971
Collaborator
NRG Oncology (Other)
450
384
2
90.2
1.2
0

Study Details

Study Description

Brief Summary

This randomized phase III trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, 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. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and cisplatin are more effective with triapine in treating cervical or vaginal cancer.

Detailed Description

PRIMARY OBJECTIVE:
  1. To evaluate the efficacy of the experimental regimen of triapine (3AP), cisplatin, and radiation to increase overall survival relative to the standard/control regimen of cisplatin and radiation in women with uterine cervix or vaginal cancer.
SECONDARY OBJECTIVE:
  1. To determine the relative progression-free survival impact of triapine-cisplatin radio-chemotherapy and cisplatin radio-chemotherapy.
TERTIARY OBJECTIVES:
  1. To evaluate incidence and severity of hematologic and gastrointestinal (GI) adverse events by radiation modality; image guided intensity modulated radiation therapy (IG-IMRT) versus conventional pelvic radiotherapy. (05/30/2017) II. To summarize and compare differences in acute adverse events (Common Terminology Criteria for Adverse Events [CTCAE], version [v]4.0) by treatment arm and by radiation modality. (05/30/2017) III. To summarize and compare differences in chronic or late (>= 30-days from off study treatment date) adverse events (CTCAE, v4.0) by treatment arm and by radiation modality. (05/30/2017) IV. To determine peripheral blood methemoglobin proportion before and after triapine infusion (optional for Arm 2 patients).

  2. To explore whether knowledge-based planning (KBP) can improve IG-IMRT plans compared to plans that would have been delivered without KBP, estimate the resulting toxicity reduction using normal tissue complication probability (NTCP) models, and determine whether KBP should be a requirement for future IG-IMRT protocols.

  3. To determine the post-therapy 3-month fludeoxyglucose F-18 (18F-FDG) PET/CT metabolic complete response rate by treatment arm VII. To compare acute toxicity and chemotherapy delivery for atlas-based IG-IMRT vs. positron emission tomography (PET)/computed tomography (CT)-based IG-IMRT vs. conventional radiation therapy (RT), and assess the impact of treatment on changes in hematopoietic compensatory response.

  4. To develop and validate machine learning and radiomics techniques for dose accumulation, automated treatment planning, and prediction of treatment response.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cisplatin intravenously (IV) over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo external beam radiation therapy (EBRT) (either conventional RT or intensity modulated radiation therapy [IMRT]) once daily (QD) 5 days a week for 25 fractions followed by low dose rate (LDR) or high dose rate (HDR) brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 and 3 months, every 3 months for 2 years, and then every 6 months for 3 years.

The patient data from NCI #9434 will be merged with NRG-GY006 per the Protocol Analysis Plan.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
450 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase III Trial of Radiation Therapy and Cisplatin Alone or in Combination With Intravenous Triapine in Women With Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer
Actual Study Start Date :
Jan 15, 2016
Anticipated Primary Completion Date :
Jul 23, 2023
Anticipated Study Completion Date :
Jul 23, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm I (cisplatin, IMRT or RT, brachytherapy)

Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity.

Radiation: Brachytherapy
Undergo brachytherapy
Other Names:
  • Brachytherapy, NOS
  • Internal Radiation
  • Internal Radiation Brachytherapy
  • Internal Radiation Therapy
  • Radiation Brachytherapy
  • Radiation, Internal
  • 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: External Beam Radiation Therapy
    Undergo EBRT
    Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam Radiation
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation
  • Radiation, External Beam
  • Teleradiotherapy
  • Teletherapy
  • Teletherapy Radiation
  • Radiation: Intensity-Modulated Radiation Therapy
    Undergo IMRT
    Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
  • Radiation, Intensity-Modulated Radiotherapy
  • Other: Laboratory Biomarker Analysis
    Correlative studies

    Radiation: Radiation Therapy
    Undergo conventional RT
    Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation
  • Experimental: Arm II (cisplatin, IMRT or RT, brachytherapy, triapine)

    Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity.

    Radiation: Brachytherapy
    Undergo brachytherapy
    Other Names:
  • Brachytherapy, NOS
  • Internal Radiation
  • Internal Radiation Brachytherapy
  • Internal Radiation Therapy
  • Radiation Brachytherapy
  • Radiation, Internal
  • 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: Intensity-Modulated Radiation Therapy
    Undergo IMRT
    Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
  • Radiation, Intensity-Modulated Radiotherapy
  • Other: Laboratory Biomarker Analysis
    Correlative studies

    Radiation: Radiation Therapy
    Undergo conventional RT
    Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation
  • Drug: Triapine
    Given IV
    Other Names:
  • 3-aminopyridine-2-carboxaldehyde thiosemicarbazone
  • 3-AP
  • 3-Apct
  • OCX-0191
  • OCX-191
  • OCX191
  • PAN-811
  • Outcome Measures

    Primary Outcome Measures

    1. Overall survival (OS) [Time (in months) since registration (and randomization) onto the study to the date death or last contact, assessed up to 5 years]

      Product-limit estimates according to the method of Kaplan and Meier and the one sided log-rank test (alpha = 0.1) will be used to compare survival endpoint (OS) between treatment arms. In addition, adjusted hazard ratios and respective 95% confidence intervals will be calculated using the Cox proportional hazards regression model.

    Secondary Outcome Measures

    1. Progression-free survival (PFS) [Time (in months) since registration (and randomization) onto the study to the date of first documented recurrence/progression, death or last follow-up visit (contact), assessed up to 5 years]

      Product-limit estimates according to the method of Kaplan and Meier and the one sided log-rank test (alpha = 0.1) will be used to compare survival endpoint (PFS) between treatment arms. In addition, adjusted hazard ratios and respective 95% confidence intervals will be calculated using the Cox proportional hazards regression model.

    2. Metabolic complete response (mCR) [Up to 3 months after completion of treatment]

      Will be assessed by fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT). Frequency of mCR will be tabulated and the probability of attaining a mCR will be estimated. Differences in mCR rate between treatment arms will be assessed using either the Chi-square or Fisher's exact test. The relationship between patients' mCR status at T1 (yes or no) and PFS (and/or OS) will be assessed using regression models to facilitate evaluation of mCR as secondary short term endpoint for patient outcome.

    3. Incidence of acute adverse events [Up to 30 days after completion of study treatment]

      Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The frequency and severity of adverse events will be assessed. Maximum grade of adverse effect will be tabulated for each adverse event and significance of observed differences between treatments arms within each adverse event category will be assessed using Chi-square or Fishers' exact test.

    4. Treatment compliance (amount of radiation, cisplatin and triapine administered, incidence and duration of treatment delays, reason for delays, and reason why off study therapy) [Up to 5 years]

      Treatment compliance will be evaluated and reported.

    5. Incidence of hematologic and gastrointestinal (GI) adverse events [Up to 30 days after completion of study treatment]

      Will be assessed by CTCAE version 4. The frequency and severity of adverse events will be assessed. Maximum grade of adverse effect will be tabulated for each adverse event and significance of observed differences between treatments arms within each adverse event category will be assessed using Chi-square or Fishers' exact test.

    6. Incidence of chronic or late adverse events [Up to 5 years]

      Will be assessed by CTACE version 4. The frequency and severity of adverse events will be assessed. Maximum grade of adverse effect will be tabulated for each adverse event and significance of observed differences between treatments arms within each adverse event category will be assessed using Chi-square or Fishers' exact test.

    Other Outcome Measures

    1. Changes in the proportion of peripheral blood methemoglobin [Baseline to 24 hours after triapine infusion]

      Difference in peak or in trend of blood methemoglobin levels before and after triapine infusion will be assessed using two tailed paired T-test at alpha = 0.05 significance level. Depending on the observed within subjects correlation, repeated measures analysis of variance may be utilized instead.

    2. Type of intensity modulated radiation therapy (IG-IMRT) [Up to 5 years]

      Will explore whether knowledge-based planning (KBP) can improve IG-IMRT plans compared to plans that would have been delivered without KBP, estimate the resulting toxicity reduction using normal tissue complication probability (NTCP) models, and determine whether KBP should be a requirement for future IG-IMRT protocols

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient has a new, unrated histologic diagnosis of stage IB2 (> 4 cm), II, IIIB or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix (FIGO 2009) or stage II-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the vagina not amenable to curative surgical resection alone; the presence or absence of para-aortic lymph node metastasis will be based on pre-therapy 18F-FDG PET/CT; NOTE: if the baseline 18F-FDG PET/CT identifies hypermetabolic para-aortic disease, such patients will NOT be eligible; the patient must be able to tolerate imaging requirements of an 18F-FDG PET/CT scan

    • Patient must provide study specific informed consent prior to study entry

    • Patient must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2 or equivalent

    • Absolute neutrophil count > 1,500/uL

    • Platelets > 100,000/uL

    • Hemoglobin > 10 g/dL

    • Total bilirubin < 2.0 mg/dL

    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 X institutional upper limit of normal

    • Prothrombin time (PT)/activated partial thromboplastin time (aPTT) < 1.5 X institutional upper limit of normal

    • Creatinine =< 1.5 mg/dL to receive weekly cisplatin

    • Patients whose serum creatinine is between 1.5 and 1.9 mg/dL are eligible for cisplatin if the estimated creatinine clearance (CCr) is >= 30 ml/min; for the purpose of estimating the CCr, the formula of Cockcroft and Gault for females should be used

    • Patient does not have uncontrolled diabetes mellitus (i.e., fasting blood glucose > 200 mg/dL)

    • Patient has a life expectancy of greater than 20 weeks

    • Patient does not have known brain metastases (testing optional)

    • Patient does not have known human immunodeficiency virus syndrome (HIV, testing optional); known HIV-positive patients receiving combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with triapine

    • Patient does not have a known allergy to compounds of similar or biologic composition as triapine

    • Patient does not have known glucose-6-phosphate dehydrogenase (G6PD) deficiency as the condition interferes with triapine antidote metabolism (G6PD testing optional)

    • Patient is not actively breastfeeding (or has agreed to discontinue breastfeeding before the initiation of protocol therapy)

    Exclusion Criteria:
    • Patient has another concurrent active invasive malignancy

    • Patient has had a prior invasive malignancy diagnosed within the last three years (except [1] non-melanoma skin cancer or [2] prior in situ carcinoma of the cervix); patients are excluded if they have received prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues at the discretion of the treating physician

    • Patient has uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within six months of protocol initiation, cardiac arrhythmia within six months of protocol initiation; known inadequately controlled hypertension; clinically significant pulmonary disease including dyspnea at rest, or patients requiring supplemental oxygen, or poor pulmonary reserve; or clinically significant renal function impairment (baseline serum creatinine > 2 mg/dL); or psychiatric illness/social situations that would limit compliance with study requirements

    • Patient is receiving another investigational agent for the treatment of cancer

    • Patient is currently pregnant

    • Patient does not agree to use two forms of birth control if they are of child-bearing potential

    • Patients who have had a hysterectomy or are planning to have an adjuvant hysterectomy following radiation as part of their cervical cancer treatment are ineligible (05/30/2017)

    • Patients scheduled to be treated with adjuvant consolidation chemotherapy or other anti-neoplastic therapy at the conclusion of their standard chemoradiation (05/30/2017)

    • Patients with self-reported or known diagnosis of G6PD deficiency (05/30/2017)

    • Patients with vaginal cancer may have previously undergone a hysterectomy for various indications; patients with vaginal cancer who underwent a hysterectomy for treatment of cervical cancer less than five years prior to their diagnosis of vaginal cancer are ineligible

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Cancer Center Birmingham Alabama United States 35233
    2 Anchorage Associates in Radiation Medicine Anchorage Alaska United States 98508
    3 Alaska Breast Care and Surgery LLC Anchorage Alaska United States 99508
    4 Alaska Oncology and Hematology LLC Anchorage Alaska United States 99508
    5 Alaska Women's Cancer Care Anchorage Alaska United States 99508
    6 Anchorage Oncology Centre Anchorage Alaska United States 99508
    7 Katmai Oncology Group Anchorage Alaska United States 99508
    8 Providence Alaska Medical Center Anchorage Alaska United States 99508
    9 Fairbanks Memorial Hospital Fairbanks Alaska United States 99701
    10 Banner University Medical Center - Tucson Tucson Arizona United States 85719
    11 University of Arizona Cancer Center-North Campus Tucson Arizona United States 85719
    12 CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas United States 71913
    13 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    14 Kaiser Permanente-Deer Valley Medical Center Antioch California United States 94531
    15 Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California United States 91505
    16 Kaiser Permanente-Fremont Fremont California United States 94538
    17 Kaiser Permanente-Fresno Fresno California United States 93720
    18 UC San Diego Moores Cancer Center La Jolla California United States 92093
    19 Los Angeles County-USC Medical Center Los Angeles California United States 90033
    20 Kaiser Permanente-Modesto Modesto California United States 95356
    21 Kaiser Permanente Oakland-Broadway Oakland California United States 94611
    22 Kaiser Permanente-Oakland Oakland California United States 94611
    23 UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California United States 92868
    24 Kaiser Permanente-Rancho Cordova Cancer Center Rancho Cordova California United States 95670
    25 Kaiser Permanente-Redwood City Redwood City California United States 94063
    26 Kaiser Permanente-Richmond Richmond California United States 94801
    27 Rohnert Park Cancer Center Rohnert Park California United States 94928
    28 Kaiser Permanente-Roseville Roseville California United States 95661
    29 The Permanente Medical Group-Roseville Radiation Oncology Roseville California United States 95678
    30 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    31 Kaiser Permanente-South Sacramento Sacramento California United States 95823
    32 South Sacramento Cancer Center Sacramento California United States 95823
    33 Kaiser Permanente - Sacramento Sacramento California United States 95825
    34 Kaiser Permanente-San Francisco San Francisco California United States 94115
    35 Kaiser Permanente-Santa Teresa-San Jose San Jose California United States 95119
    36 Kaiser Permanente San Leandro San Leandro California United States 94577
    37 Kaiser Permanente-San Rafael San Rafael California United States 94903
    38 Kaiser San Rafael-Gallinas San Rafael California United States 94903
    39 Kaiser Permanente Medical Center - Santa Clara Santa Clara California United States 95051
    40 Kaiser Permanente-Santa Rosa Santa Rosa California United States 95403
    41 Kaiser Permanente Cancer Treatment Center South San Francisco California United States 94080
    42 Kaiser Permanente-South San Francisco South San Francisco California United States 94080
    43 Kaiser Permanente-Stockton Stockton California United States 95210
    44 Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee California United States 96161
    45 Kaiser Permanente Medical Center-Vacaville Vacaville California United States 95688
    46 Kaiser Permanente-Vallejo Vallejo California United States 94589
    47 Kaiser Permanente-Walnut Creek Walnut Creek California United States 94596
    48 University of Colorado Hospital Aurora Colorado United States 80045
    49 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
    50 Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado United States 80907
    51 Porter Adventist Hospital Denver Colorado United States 80210
    52 Saint Anthony Hospital Lakewood Colorado United States 80228
    53 Littleton Adventist Hospital Littleton Colorado United States 80122
    54 Longmont United Hospital Longmont Colorado United States 80501
    55 Saint Mary Corwin Medical Center Pueblo Colorado United States 81004
    56 Rocky Mountain Cancer Centers-Thornton Thornton Colorado United States 80260
    57 Hartford Hospital Hartford Connecticut United States 06102
    58 Beebe Medical Center Lewes Delaware United States 19958
    59 Christiana Gynecologic Oncology LLC Newark Delaware United States 19713
    60 Delaware Clinical and Laboratory Physicians PA Newark Delaware United States 19713
    61 Helen F Graham Cancer Center Newark Delaware United States 19713
    62 Medical Oncology Hematology Consultants PA Newark Delaware United States 19713
    63 Christiana Care Health System-Christiana Hospital Newark Delaware United States 19718
    64 University of Florida Health Science Center - Gainesville Gainesville Florida United States 32610
    65 Mayo Clinic in Florida Jacksonville Florida United States 32224-9980
    66 Lakeland Regional Health Hollis Cancer Center Lakeland Florida United States 33805
    67 Moffitt Cancer Center Tampa Florida United States 33612
    68 Emory University Hospital Midtown Atlanta Georgia United States 30308
    69 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322
    70 Emory Saint Joseph's Hospital Atlanta Georgia United States 30342
    71 Augusta University Medical Center Augusta Georgia United States 30912
    72 Memorial Health University Medical Center Savannah Georgia United States 31404
    73 Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia United States 31405
    74 Pali Momi Medical Center 'Aiea Hawaii United States 96701
    75 Queen's Cancer Center - Pearlridge 'Aiea Hawaii United States 96701
    76 The Cancer Center of Hawaii-Pali Momi 'Aiea Hawaii United States 96701
    77 Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii United States 96813
    78 Island Urology Honolulu Hawaii United States 96813
    79 Queen's Medical Center Honolulu Hawaii United States 96813
    80 Straub Clinic and Hospital Honolulu Hawaii United States 96813
    81 University of Hawaii Cancer Center Honolulu Hawaii United States 96813
    82 Hawaii Cancer Care Inc-Liliha Honolulu Hawaii United States 96817
    83 Kuakini Medical Center Honolulu Hawaii United States 96817
    84 Queen's Cancer Center - Kuakini Honolulu Hawaii United States 96817
    85 The Cancer Center of Hawaii-Liliha Honolulu Hawaii United States 96817
    86 Kaiser Permanente Moanalua Medical Center Honolulu Hawaii United States 96819
    87 Kapiolani Medical Center for Women and Children Honolulu Hawaii United States 96826
    88 Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii United States 96766
    89 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
    90 Saint Luke's Cancer Institute - Boise Boise Idaho United States 83712
    91 Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho United States 83605
    92 Saint Luke's Cancer Institute - Fruitland Fruitland Idaho United States 83619
    93 Saint Luke's Cancer Institute - Meridian Meridian Idaho United States 83642
    94 Saint Luke's Cancer Institute - Nampa Nampa Idaho United States 83686
    95 Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho United States 83854
    96 Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho United States 83301
    97 Saint Joseph Medical Center Bloomington Illinois United States 61701
    98 Memorial Hospital of Carbondale Carbondale Illinois United States 62902
    99 Northwestern University Chicago Illinois United States 60611
    100 John H Stroger Jr Hospital of Cook County Chicago Illinois United States 60612
    101 Rush University Medical Center Chicago Illinois United States 60612
    102 Cancer Care Specialists of Illinois - Decatur Decatur Illinois United States 62526
    103 Decatur Memorial Hospital Decatur Illinois United States 62526
    104 Crossroads Cancer Center Effingham Illinois United States 62401
    105 Western Illinois Cancer Treatment Center Galesburg Illinois United States 61401
    106 Northwestern Medicine Cancer Center Delnor Geneva Illinois United States 60134
    107 Loyola University Medical Center Maywood Illinois United States 60153
    108 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
    109 Cancer Care Center of O'Fallon O'Fallon Illinois United States 62269
    110 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    111 Radiation Oncology of Northern Illinois Ottawa Illinois United States 61350
    112 OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois United States 61554
    113 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    114 OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois United States 61615
    115 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    116 OSF Saint Francis Medical Center Peoria Illinois United States 61637
    117 Illinois CancerCare-Peru Peru Illinois United States 61354
    118 Valley Radiation Oncology Peru Illinois United States 61354
    119 Illinois CancerCare-Princeton Princeton Illinois United States 61356
    120 Central Illinois Hematology Oncology Center Springfield Illinois United States 62702
    121 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    122 Springfield Clinic Springfield Illinois United States 62702
    123 Memorial Medical Center Springfield Illinois United States 62781
    124 Southwest Illinois Health Services LLP Swansea Illinois United States 62226
    125 Carle Cancer Center Urbana Illinois United States 61801
    126 Northwestern Medicine Cancer Center Warrenville Warrenville Illinois United States 60555
    127 Parkview Hospital Randallia Fort Wayne Indiana United States 46805
    128 Parkview Regional Medical Center Fort Wayne Indiana United States 46845
    129 Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana United States 46202
    130 Sidney and Lois Eskenazi Hospital Indianapolis Indiana United States 46202
    131 Saint Vincent Hospital and Health Care Center Indianapolis Indiana United States 46260
    132 Reid Health Richmond Indiana United States 47374
    133 Mercy Hospital Cedar Rapids Iowa United States 52403
    134 Oncology Associates at Mercy Medical Center Cedar Rapids Iowa United States 52403
    135 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa United States 50325
    136 Mercy Cancer Center-West Lakes Clive Iowa United States 50325
    137 Iowa Methodist Medical Center Des Moines Iowa United States 50309
    138 Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa United States 50309
    139 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
    140 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    141 Iowa Lutheran Hospital Des Moines Iowa United States 50316
    142 Methodist West Hospital West Des Moines Iowa United States 50266-7700
    143 Mercy Medical Center-West Lakes West Des Moines Iowa United States 50266
    144 Saint Catherine Hospital Garden City Kansas United States 67846
    145 Saint Rose Ambulatory and Surgery Center Great Bend Kansas United States 67530
    146 HaysMed University of Kansas Health System Hays Kansas United States 67601
    147 University of Kansas Cancer Center Kansas City Kansas United States 66160
    148 Olathe Health Cancer Center Olathe Kansas United States 66061
    149 University of Kansas Cancer Center-Overland Park Overland Park Kansas United States 66210
    150 Ascension Via Christi - Pittsburg Pittsburg Kansas United States 66762
    151 Salina Regional Health Center Salina Kansas United States 67401
    152 University of Kansas Health System Saint Francis Campus Topeka Kansas United States 66606
    153 Saint Joseph Radiation Oncology Resource Center Lexington Kentucky United States 40504
    154 Saint Joseph Hospital East Lexington Kentucky United States 40509
    155 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
    156 Jewish Hospital Louisville Kentucky United States 40202
    157 The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky United States 40202
    158 UofL Health Medical Center Northeast Louisville Kentucky United States 40245
    159 East Jefferson General Hospital Metairie Louisiana United States 70006
    160 University Medical Center New Orleans New Orleans Louisiana United States 70112
    161 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
    162 Greater Baltimore Medical Center Baltimore Maryland United States 21204
    163 Walter Reed National Military Medical Center Bethesda Maryland United States 20889-5600
    164 Henry Ford Cancer Institute-Downriver Brownstown Michigan United States 48183
    165 Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan United States 48038
    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 Mercy Health Saint Mary's Grand Rapids Michigan United States 49503
    170 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
    171 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    172 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    173 Borgess Medical Center Kalamazoo Michigan United States 49048
    174 Mercy Health Mercy Campus Muskegon Michigan United States 49444
    175 Spectrum Health Reed City Hospital Reed City Michigan United States 49677
    176 Lakeland Medical Center Saint Joseph Saint Joseph Michigan United States 49085
    177 Munson Medical Center Traverse City Michigan United States 49684
    178 Henry Ford West Bloomfield Hospital West Bloomfield Michigan United States 48322
    179 Metro Health Hospital Wyoming Michigan United States 49519
    180 University of Minnesota/Masonic Cancer Center Minneapolis Minnesota United States 55455
    181 Mayo Clinic in Rochester Rochester Minnesota United States 55905
    182 University of Mississippi Medical Center Jackson Mississippi United States 39216
    183 Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri United States 63011
    184 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    185 Southeast Cancer Center Cape Girardeau Missouri United States 63703
    186 Capital Region Southwest Campus Jefferson City Missouri United States 65109
    187 Freeman Health System Joplin Missouri United States 64804
    188 North Kansas City Hospital Kansas City Missouri United States 64116
    189 The University of Kansas Cancer Center-South Kansas City Missouri United States 64131
    190 University of Kansas Cancer Center - North Kansas City Missouri United States 64154
    191 University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri United States 64064
    192 Delbert Day Cancer Institute at PCRMC Rolla Missouri United States 65401
    193 Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri United States 65401
    194 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    195 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    196 Mercy Hospital Springfield Springfield Missouri United States 65804
    197 CoxHealth South Hospital Springfield Missouri United States 65807
    198 Billings Clinic Cancer Center Billings Montana United States 59101
    199 Saint Vincent Healthcare Billings Montana United States 59101
    200 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    201 Saint James Community Hospital and Cancer Treatment Center Butte Montana United States 59701
    202 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    203 Great Falls Clinic Great Falls Montana United States 59405
    204 Kalispell Regional Medical Center Kalispell Montana United States 59901
    205 Community Medical Hospital Missoula Montana United States 59804
    206 CHI Health Saint Francis Grand Island Nebraska United States 68803
    207 CHI Health Good Samaritan Kearney Nebraska United States 68847
    208 Nebraska Methodist Hospital Omaha Nebraska United States 68114
    209 Alegent Health Immanuel Medical Center Omaha Nebraska United States 68122
    210 Alegent Health Bergan Mercy Medical Center Omaha Nebraska United States 68124
    211 Alegent Health Lakeside Hospital Omaha Nebraska United States 68130
    212 Creighton University Medical Center Omaha Nebraska United States 68131
    213 University of Nebraska Medical Center Omaha Nebraska United States 68198
    214 Midlands Community Hospital Papillion Nebraska United States 68046
    215 Radiation Oncology Centers of Nevada Central Las Vegas Nevada United States 89106
    216 Women's Cancer Center of Nevada Las Vegas Nevada United States 89106
    217 Center of Hope at Renown Medical Center Reno Nevada United States 89502
    218 Renown Regional Medical Center Reno Nevada United States 89502
    219 Cooper Hospital University Medical Center Camden New Jersey United States 08103
    220 Hackensack University Medical Center Hackensack New Jersey United States 07601
    221 Virtua Memorial Mount Holly New Jersey United States 08060
    222 Cooper CyberKnife Center Mount Laurel New Jersey United States 08054
    223 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08903
    224 Rutgers New Jersey Medical School Newark New Jersey United States 07101
    225 Robert Wood Johnson University Hospital Somerset Somerville New Jersey United States 08876
    226 MD Anderson Cancer Center at Cooper-Voorhees Voorhees New Jersey United States 08043
    227 Virtua Voorhees Voorhees New Jersey United States 08043
    228 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
    229 Southwest Gynecologic Oncology Associates Inc Albuquerque New Mexico United States 87106
    230 Memorial Medical Center - Las Cruces Las Cruces New Mexico United States 88011
    231 Saint Peter's Health Partners Albany New York United States 12208
    232 Women's Cancer Care Associates LLC Albany New York United States 12208
    233 Maimonides Medical Center Brooklyn New York United States 11219
    234 Roswell Park Cancer Institute Buffalo New York United States 14263
    235 Mount Sinai Chelsea New York New York United States 10011
    236 Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York United States 10016
    237 Highland Hospital Rochester New York United States 14620
    238 University of Rochester Rochester New York United States 14642
    239 State University of New York Upstate Medical University Syracuse New York United States 13210
    240 Novant Health Presbyterian Medical Center Charlotte North Carolina United States 28204
    241 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    242 Summa Health System - Akron Campus Akron Ohio United States 44304
    243 UHHS-Chagrin Highlands Medical Center Beachwood Ohio United States 44122
    244 Aultman Health Foundation Canton Ohio United States 44710
    245 Miami Valley Hospital South Centerville Ohio United States 45459
    246 Geauga Hospital Chardon Ohio United States 44024
    247 Adena Regional Medical Center Chillicothe Ohio United States 45601
    248 University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio United States 45219
    249 Good Samaritan Hospital - Cincinnati Cincinnati Ohio United States 45220
    250 Bethesda North Hospital Cincinnati Ohio United States 45242
    251 Oncology Hematology Care Inc-Blue Ash Cincinnati Ohio United States 45242
    252 Case Western Reserve University Cleveland Ohio United States 44106
    253 MetroHealth Medical Center Cleveland Ohio United States 44109
    254 Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio United States 44111
    255 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    256 Mount Carmel East Hospital Columbus Ohio United States 43213
    257 Riverside Methodist Hospital Columbus Ohio United States 43214
    258 Grant Medical Center Columbus Ohio United States 43215
    259 The Mark H Zangmeister Center Columbus Ohio United States 43219
    260 Mount Carmel Health Center West Columbus Ohio United States 43222
    261 Doctors Hospital Columbus Ohio United States 43228
    262 Good Samaritan Hospital - Dayton Dayton Ohio United States 45406
    263 Miami Valley Hospital Dayton Ohio United States 45409
    264 Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio United States 45415
    265 Miami Valley Hospital North Dayton Ohio United States 45415
    266 Delaware Radiation Oncology Delaware Ohio United States 43015
    267 Grady Memorial Hospital Delaware Ohio United States 43015
    268 Blanchard Valley Hospital Findlay Ohio United States 45840
    269 Atrium Medical Center-Middletown Regional Hospital Franklin Ohio United States 45005-1066
    270 Wayne Hospital Greenville Ohio United States 45331
    271 Kettering Medical Center Kettering Ohio United States 45429
    272 OhioHealth Mansfield Hospital Mansfield Ohio United States 44903
    273 Marietta Memorial Hospital Marietta Ohio United States 45750
    274 Hillcrest Hospital Cancer Center Mayfield Heights Ohio United States 44124
    275 UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio United States 44060
    276 Licking Memorial Hospital Newark Ohio United States 43055
    277 Newark Radiation Oncology Newark Ohio United States 43055
    278 Southern Ohio Medical Center Portsmouth Ohio United States 45662
    279 Springfield Regional Medical Center Springfield Ohio United States 45505
    280 ProMedica Flower Hospital Sylvania Ohio United States 43560
    281 ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio United States 43606
    282 Upper Valley Medical Center Troy Ohio United States 45373
    283 University Hospitals Sharon Health Center Wadsworth Ohio United States 44281
    284 University of Cincinnati Cancer Center-West Chester West Chester Ohio United States 45069
    285 Saint Ann's Hospital Westerville Ohio United States 43081
    286 UH Seidman Cancer Center at Saint John Medical Center Westlake Ohio United States 44145
    287 UHHS-Westlake Medical Center Westlake Ohio United States 44145
    288 Genesis Healthcare System Cancer Care Center Zanesville Ohio United States 43701
    289 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    290 Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma United States 74146
    291 Saint Charles Health System Bend Oregon United States 97701
    292 Clackamas Radiation Oncology Center Clackamas Oregon United States 97015
    293 Bay Area Hospital Coos Bay Oregon United States 97420
    294 Legacy Mount Hood Medical Center Gresham Oregon United States 97030
    295 Legacy Good Samaritan Hospital and Medical Center Portland Oregon United States 97210
    296 Providence Portland Medical Center Portland Oregon United States 97213
    297 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    298 Legacy Meridian Park Hospital Tualatin Oregon United States 97062
    299 Jefferson Abington Hospital Abington Pennsylvania United States 19001
    300 UPMC-Heritage Valley Health System Beaver Beaver Pennsylvania United States 15009
    301 Christiana Care Health System-Concord Health Center Chadds Ford Pennsylvania United States 19317
    302 Northeast Radiation Oncology Center Dunmore Pennsylvania United States 18512
    303 Ephrata Cancer Center Ephrata Pennsylvania United States 17522
    304 Adams Cancer Center Gettysburg Pennsylvania United States 17325
    305 UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg Pennsylvania United States 15601
    306 Cherry Tree Cancer Center Hanover Pennsylvania United States 17331
    307 UPMC-Coraopolis/Heritage Valley Radiation Oncology Moon Pennsylvania United States 15108
    308 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
    309 UPMC-Magee Womens Hospital Pittsburgh Pennsylvania United States 15213
    310 University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania United States 15232
    311 UPMC-Shadyside Hospital Pittsburgh Pennsylvania United States 15232
    312 Reading Hospital West Reading Pennsylvania United States 19611
    313 Asplundh Cancer Pavilion Willow Grove Pennsylvania United States 19090
    314 Lankenau Medical Center Wynnewood Pennsylvania United States 19096
    315 WellSpan Health-York Cancer Center York Pennsylvania United States 17403
    316 WellSpan Health-York Hospital York Pennsylvania United States 17403
    317 Women and Infants Hospital Providence Rhode Island United States 02905
    318 Saint Francis Hospital Greenville South Carolina United States 29601
    319 Prisma Health Cancer Institute - Faris Greenville South Carolina United States 29605
    320 Saint Francis Cancer Center Greenville South Carolina United States 29607
    321 Spartanburg Medical Center Spartanburg South Carolina United States 29303
    322 Rapid City Regional Hospital Rapid City South Dakota United States 57701
    323 Memorial Hospital Chattanooga Tennessee United States 37404
    324 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
    325 Saint Joseph Regional Cancer Center Bryan Texas United States 77802
    326 Parkland Memorial Hospital Dallas Texas United States 75235
    327 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
    328 Houston Methodist Hospital Houston Texas United States 77030
    329 Memorial Hermann Texas Medical Center Houston Texas United States 77030
    330 Methodist Willowbrook Hospital Houston Texas United States 77070
    331 Houston Methodist Sugar Land Hospital Sugar Land Texas United States 77479
    332 Houston Methodist The Woodlands Hospital The Woodlands Texas United States 77385
    333 Sandra L Maxwell Cancer Center Cedar City Utah United States 84720
    334 Logan Regional Hospital Logan Utah United States 84321
    335 Intermountain Medical Center Murray Utah United States 84107
    336 McKay-Dee Hospital Center Ogden Utah United States 84403
    337 Utah Valley Regional Medical Center Provo Utah United States 84604
    338 Saint George Regional Medical Center Saint George Utah United States 84770
    339 Utah Cancer Specialists-Salt Lake City Salt Lake City Utah United States 84106
    340 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
    341 LDS Hospital Salt Lake City Utah United States 84143
    342 South Jordan Health Center South Jordan Utah United States 84009
    343 Providence Regional Cancer System-Aberdeen Aberdeen Washington United States 98520
    344 MultiCare Auburn Medical Center Auburn Washington United States 98001
    345 Overlake Medical Center Bellevue Washington United States 98004
    346 PeaceHealth Saint Joseph Medical Center Bellingham Washington United States 98225
    347 Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington United States 98310
    348 Harrison Medical Center Bremerton Washington United States 98310
    349 Highline Medical Center-Main Campus Burien Washington United States 98166
    350 Providence Regional Cancer System-Centralia Centralia Washington United States 98531
    351 Providence Regional Cancer Partnership Everett Washington United States 98201
    352 Virginia Mason Federal Way Medical Center Federal Way Washington United States 98002
    353 Tacoma/Valley Radiation Oncology Centers-Gig Harbor Gig Harbor Washington United States 98332
    354 MultiCare Gig Harbor Medical Park Gig Harbor Washington United States 98335
    355 Swedish Cancer Institute-Issaquah Issaquah Washington United States 98029
    356 Providence Regional Cancer System-Lacey Lacey Washington United States 98503
    357 PeaceHealth Saint John Medical Center Longview Washington United States 98632
    358 MultiCare Good Samaritan Hospital Puyallup Washington United States 98372
    359 Tacoma/Valley Radiation Oncology Centers-Puyallup Puyallup Washington United States 98372
    360 Virginia Mason Medical Center Seattle Washington United States 98101
    361 Seattle Cancer Care Alliance Seattle Washington United States 98109
    362 Kaiser Permanente Washington Seattle Washington United States 98112
    363 Swedish Medical Center-First Hill Seattle Washington United States 98122-4307
    364 MultiCare Tacoma General Hospital Tacoma Washington United States 98405
    365 Northwest Medical Specialties PLLC Tacoma Washington United States 98405
    366 Tacoma/Valley Radiation Oncology Centers-Saint Joe's Tacoma Washington United States 98405
    367 PeaceHealth Southwest Medical Center Vancouver Washington United States 98664
    368 Legacy Salmon Creek Hospital Vancouver Washington United States 98686
    369 Providence Saint Mary Regional Cancer Center Walla Walla Washington United States 99362
    370 North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington United States 98902
    371 Edwards Comprehensive Cancer Center Huntington West Virginia United States 25701
    372 West Virginia University Healthcare Morgantown West Virginia United States 26506
    373 Wheeling Hospital/Schiffler Cancer Center Wheeling West Virginia United States 26003
    374 Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin United States 54701
    375 University of Wisconsin Carbone Cancer Center Madison Wisconsin United States 53792
    376 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    377 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    378 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
    379 Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin United States 54482
    380 Marshfield Medical Center - Weston Weston Wisconsin United States 54476
    381 Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5
    382 San Juan Community Oncology Group San Juan Puerto Rico 00917
    383 Centro Comprensivo de Cancer de UPR San Juan Puerto Rico 00927
    384 San Juan City Hospital San Juan Puerto Rico 00936

    Sponsors and Collaborators

    • National Cancer Institute (NCI)
    • NRG Oncology

    Investigators

    • Principal Investigator: Charles A Leath, NRG Oncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT02466971
    Other Study ID Numbers:
    • NCI-2015-00835
    • NCI-2015-00835
    • NRG-GY006
    • NRG-GY006
    • NRG-GY006
    • U10CA180868
    • NCT01835171
    First Posted:
    Jun 9, 2015
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Mar 1, 2022
    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