Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine®) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma

Sponsor
NRG Oncology (Other)
Overall Status
Recruiting
CT.gov ID
NCT05095376
Collaborator
National Cancer Institute (NCI) (NIH)
306
120
2
116.3
2.6
0

Study Details

Study Description

Brief Summary

This phase III trial compares the effect of adding lomustine to temozolomide and radiation therapy versus temozolomide and radiation therapy alone in shrinking or stabilizing newly diagnosed MGMT methylated glioblastoma. Chemotherapy drugs, such as lomustine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Adding lomustine to usual treatment of temozolomide and radiation therapy may help shrink and stabilize glioblastoma.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

PRIMARY OBJECTIVE:
  1. To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy (RT) significantly prolongs overall survival (OS) versus (vs.) standard chemoradiotherapy with temozolomide in patients with newly diagnosed glioblastoma (GBM) with MGMT promoter methylation.
SECONDARY OBJECTIVES:
  1. To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy (RT) significantly prolongs progression-free survival (PFS) vs. standard chemoradiotherapy with temozolomide in patients with newly diagnosed GBM with MGMT promoter methylation.

  2. To compare the two different chemotherapy regimens on patient-reported outcomes (PROs), as measured by the MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) in patients with newly diagnosed GBM with MGMT promoter methylation.

  3. To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy (RT) is associated with inferior short-term change in patient reported outcomes (PROs) as measured by MDASI-BT vs. standard chemoradiotherapy with temozolomide in patients with newly diagnosed GBM with MGMT promoter methylation.

  4. To assess toxicity in the two different chemotherapy regimens.

EXPLORATORY OBJECTIVES:
  1. To assess the association between absolute lymphocyte counts and outcomes. II. To assess the association between CD4+ lymphocyte counts and outcomes. III. To compare the two different chemotherapy regimens in terms of long-term PROs as measured by MDASI-BT at years 1 and 2.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo radiation therapy 5 days per week and receive temozolomide orally (PO) once daily (QD) for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive lomustine PO on day 1 and temozolomide PO QD on days 2-6. Treatment repeats every 42 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for year 1, every 4 months for year 2, and then every 6 months thereafter.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
306 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase III Trial of Gleostine® (Lomustine)-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients With Methylated MGMT Promoter Glioblastoma
Actual Study Start Date :
Nov 29, 2021
Anticipated Primary Completion Date :
Aug 8, 2026
Anticipated Study Completion Date :
Aug 8, 2031

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm I (radiation therapy, temozolomide)

Patients undergo radiation therapy 5 days per week and receive temozolomide PO QD for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

Radiation: Photon Beam Radiation Therapy
Undergo radiation therapy
Other Names:
  • Photon EBRT
  • Photon External Beam Radiotherapy
  • Radiation, Photon Beam
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Drug: Temozolomide
    Given PO
    Other Names:
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-
  • M & B 39831
  • M and B 39831
  • Methazolastone
  • RP-46161
  • SCH 52365
  • Temcad
  • Temodal
  • Temodar
  • Temomedac
  • TMZ
  • Experimental: ARM II (radiation therapy, temozolomide, lomustine)

    Patients undergo radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive lomustine PO on day 1 and temozolomide PO QD on days 2-6. Treatment repeats every 42 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

    Drug: Lomustine
    Given PO
    Other Names:
  • 1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea
  • 1-Nitrosourea, 1-(2-chloroethyl)-3-cyclohexyl-
  • Belustin
  • Belustine
  • CCNU
  • Cecenu
  • CeeNU
  • Chloroethylcyclohexylnitrosourea
  • Citostal
  • Gleostine
  • Lomeblastin
  • Lomustinum
  • Lucostin
  • Lucostine
  • N-(2-Chloroethyl)-N'-cyclohexyl-N-nitrosourea
  • Prava
  • RB-1509
  • WR-139017
  • Radiation: Photon Beam Radiation Therapy
    Undergo radiation therapy
    Other Names:
  • Photon EBRT
  • Photon External Beam Radiotherapy
  • Radiation, Photon Beam
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Drug: Temozolomide
    Given PO
    Other Names:
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-
  • M & B 39831
  • M and B 39831
  • Methazolastone
  • RP-46161
  • SCH 52365
  • Temcad
  • Temodal
  • Temodar
  • Temomedac
  • TMZ
  • Outcome Measures

    Primary Outcome Measures

    1. Overall Survival [From randomization to death due to any cause, assessed up to 4 years]

      The Kaplan-Meier method will be used to estimate survival distribution for each treatment arm.

    Secondary Outcome Measures

    1. Progression Free Survival (PFS) [From randomization to disease progression or death due to any cause, whichever occurs first, assessed up to 4 years]

      Analysis will consist of estimation of the PFS distribution of each treatment arm via the Kaplan-Meier method and a stratified log-rank test. Additional analyses may consist of estimating the hazard ratio (HR) via the Cox proportional hazards model, accounting for other prognostic covariates (and evaluating whether the proportional hazards assumption holds or whether any treatment effect is notably time-varying), and evaluating for potential treatment by prognostic covariate interactions.

    2. Incidence of Adverse Events [Up to 4 years]

      Adverse events (AEs) will be graded according to Common Terminology Criteria for Adverse Events version 5.0. Comprehensive summaries of all AEs by treatment arm will be generated and examined.

    3. Patient reported outcomes for Brain Tumors [Up to 4 years]

      Measured by the MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) in patients with newly diagnosed glioblastoma with MGMT promoter methylation.

    Other Outcome Measures

    1. Absolute lymphocyte counts [Up to 4 years]

      Will assess the association between absolute lymphocyte counts and outcomes.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • STEP 1 REGISTRATION: No known IDH mutation. (If tested before step 1 registration, patients known to have IDH mutation in the tumor on local or other testing are ineligible and should not be registered)

    • STEP 1 REGISTRATION: Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block and hematoxylin and eosin (H&E) stained slide to be sent for central pathology review for confirmation of histology and MGMT promoter methylation status. Note that tissue for central pathology review and central MGMT assessment must be received by the NYU Center for Biospecimen Research and Development (CBRD) on or before postoperative calendar day 23. If tissue cannot be received by postoperative calendar day 23, then patients may NOT enroll on this trial as central pathology review will not be complete in time for the patient to start treatment no later than 6 weeks following surgery. Results of central pathology review and central MGMT analysis will generally be conveyed to NRG Oncology within 10 business days of receipt of tissue. Note: In the event of an additional tumor resection(s), tissue must be received within 23 days of the most recent resection and the latest resection must have been performed within 30 days after the initial resection. Surgical resection is required; stereotactic biopsy alone is not allowed because it will not provide sufficient tissue for MGMT analysis

    • STEP 1 REGISTRATION: Contrast-enhanced brain MRI within 4 days after surgery

    • Magnetic resonance imaging (MRI) with Axial T2 weighted FLAIR or T2 TSE/FSE and 3D contrast-enhanced T1 sequences are required.

    • 3-dimensional (3D) pre contrast-enhanced T1 sequences are strongly suggested

    • STEP 1 REGISTRATION: Willing to use highly effective method of contraception for participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) during therapy and for 6 months after completing treatment; this inclusion is necessary because the treatment in this study may be significantly teratogenic

    • STEP 1 REGISTRATION: The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

    • STEP 2 REGISTRATION: Histopathologically proven diagnosis of glioblastoma (or gliosarcoma as a subtype of glioblastoma) confirmed by central pathology review

    • STEP 2 REGISTRATION: MGMT promoter with methylation confirmed by central pathology review (See Section 10 for details). Note: Patients with tissue that is insufficient or inadequate for analysis, fails MGMT testing, or has indeterminate or unmethylated MGMT promoter are excluded. Patients with unmethylated MGMT may be considered for enrollment on NRG-BN007

    • STEP 2 REGISTRATION: IDH mutation testing by at least one method (such as immunohistochemistry for IDH1 R132H) must be performed as part of standard of care and no mutation must be found (i.e IDH wildtype). (If a mutation is identified then the patient will be ineligible and must be registered as ineligible at Step 2.)

    • STEP 2 REGISTRATION: History/physical examination within 28 days prior to Step 2 registration

    • STEP 2 REGISTRATION: Karnofsky performance status (KPS) >= 70 within 28 days prior to Step 2 registration

    • STEP 2 REGISTRATION: Neurologic function assessment within 28 days prior to Step 2 registration

    • STEP 2 REGISTRATION: Age 18-70 years

    • STEP 2 REGISTRATION: Hemoglobin >= 10 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin (Hgb) >= 10.0 g/dl is acceptable)

    • STEP 2 REGISTRATION: Leukocytes >= 2,000/mm^3

    • STEP 2 REGISTRATION: Absolute neutrophil count >= 1,500/mm^3

    • STEP 2 REGISTRATION: Platelets >= 100,000/mm^3

    • STEP 2 REGISTRATION: Total bilirubin =< 1.5 x institutional/lab upper limit of normal (ULN)

    • STEP 2 REGISTRATION: Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) =< 2.5 x ULN

    • STEP 2 REGISTRATION: Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN

    • STEP 2 REGISTRATION: Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula

    • STEP 2 REGISTRATION: 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)

    • STEP 2 REGISTRATION: For 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, they are eligible if they have an undetectable HCV viral load

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

    • STEP 2 REGISTRATION: Known human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to step 2 registration are eligible for this trial. Testing is not required for entry into protocol

    • STEP 2 REGISTRATION: Negative serum or urine pregnancy test (in persons of childbearing potential) within 7 days prior to Step 2 registration

    • Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal

    Exclusion Criteria:
    • STEP 2 REGISTRATION: Prior therapy for tumor except for resection. For example, prior chemotherapy, immunotherapy, or targeted therapy for GBM or lower grade glioma is disallowed (including but not limited to temozolomide, lomustine, bevacizumab, any viral therapy, ipilimumab or other CTLA-4 antibody, PD-1 antibody, CD-137 agonist, CD40 antibody, PDL-1 or 2 antibody, vaccine therapy, polio or similar viral injection as treatment for the tumor, and/or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) as is prior Laser interstitial thermal therapy (LITT), Gliadel wafer, radiotherapy, radiosurgery, vaccine or other immunotherapy, brachytherapy, or convection enhanced delivery

    • Note: 5-aminolevulinic acid (ALA)-mediated fluorescent guided resection (FGR) photodynamic therapy (PDT) or fluorescein administered prior to/during surgery to aid resection is not exclusionary and is not considered a chemotherapy or intracerebral agent

    • STEP 2 REGISTRATION: Current or planned treatment with any other investigational agents for the study cancer

    • STEP 2 REGISTRATION: Definitive clinical or radiologic evidence of metastatic disease outside the brain

    • STEP 2 REGISTRATION: Prior invasive malignancy (except non-melanomatous skin cancer, cervical cancer in situ and melanoma in situ) unless disease free for a minimum of 2 years

    • STEP 2 REGISTRATION: Prior radiotherapy to the head or neck that would result in overlap of radiation therapy fields

    • STEP 2 REGISTRATION: Pregnancy and individuals unwilling to discontinue nursing due to the potential teratogenic effects and potential risk for adverse events in nursing infants

    • STEP 2 REGISTRATION: History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or lomustine

    • STEP 2 REGISTRATION: History of pulmonary fibrosis

    • STEP 2 REGISTRATION: Uncontrolled intercurrent illness including, but not limited to:

    • Ongoing or active infection requiring IV antibiotics, IV antiviral, or IV antifungal treatment

    • Symptomatic congestive heart failure, defined as New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification)

    • Unstable angina pectoris within 6 months prior to Step 2 registration

    • Uncontrolled cardiac arrhythmia

    • Psychiatric illness/social situations that would limit compliance with study requirements

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    2 Kaiser Permanente-Anaheim Anaheim California United States 92806
    3 Sutter Auburn Faith Hospital Auburn California United States 95602
    4 Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California United States 95603
    5 Alta Bates Summit Medical Center-Herrick Campus Berkeley California United States 94704
    6 John Muir Medical Center-Concord Campus Concord California United States 94520
    7 Kaiser Permanente Los Angeles Medical Center Los Angeles California United States 90027
    8 Kaiser Permanente-Ontario Ontario California United States 91761
    9 Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California United States 95661
    10 Sutter Roseville Medical Center Roseville California United States 95661
    11 Sutter Medical Center Sacramento Sacramento California United States 95816
    12 John Muir Medical Center-Walnut Creek Walnut Creek California United States 94598
    13 Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado United States 80907
    14 Littleton Adventist Hospital Littleton Colorado United States 80122
    15 Parker Adventist Hospital Parker Colorado United States 80138
    16 Rush - Copley Medical Center Aurora Illinois United States 60504
    17 Centralia Oncology Clinic Centralia Illinois United States 62801
    18 Carle on Vermilion Danville Illinois United States 61832
    19 Cancer Care Specialists of Illinois - Decatur Decatur Illinois United States 62526
    20 Decatur Memorial Hospital Decatur Illinois United States 62526
    21 Carle Physician Group-Effingham Effingham Illinois United States 62401
    22 Crossroads Cancer Center Effingham Illinois United States 62401
    23 Carle Physician Group-Mattoon/Charleston Mattoon Illinois United States 61938
    24 Cancer Care Center of O'Fallon O'Fallon Illinois United States 62269
    25 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    26 Springfield Clinic Springfield Illinois United States 62702
    27 Memorial Medical Center Springfield Illinois United States 62781
    28 Carle Cancer Center Urbana Illinois United States 61801
    29 The Carle Foundation Hospital Urbana Illinois United States 61801
    30 Mary Greeley Medical Center Ames Iowa United States 50010
    31 McFarland Clinic PC - Ames Ames Iowa United States 50010
    32 University of Kansas Cancer Center Kansas City Kansas United States 66160
    33 University of Kansas Hospital-Indian Creek Campus Overland Park Kansas United States 66211
    34 University of Kansas Hospital-Westwood Cancer Center Westwood Kansas United States 66205
    35 Lafayette Family Cancer Center-EMMC Brewer Maine United States 04412
    36 University of Maryland/Greenebaum Cancer Center Baltimore Maryland United States 21201
    37 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    38 Saint Joseph Mercy Brighton Brighton Michigan United States 48114
    39 Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan United States 48114
    40 Saint Joseph Mercy Canton Canton Michigan United States 48188
    41 Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan United States 48188
    42 Saint Joseph Mercy Chelsea Chelsea Michigan United States 48118
    43 Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan United States 48118
    44 Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan United States 49503
    45 Mercy Health Saint Mary's Grand Rapids Michigan United States 49503
    46 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
    47 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    48 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    49 Borgess Medical Center Kalamazoo Michigan United States 49048
    50 Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan United States 48154
    51 Metro Health Hospital Wyoming Michigan United States 49519
    52 Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan United States 48197
    53 Sanford Joe Lueken Cancer Center Bemidji Minnesota United States 56601
    54 Minnesota Oncology - Burnsville Burnsville Minnesota United States 55337
    55 Fairview Southdale Hospital Edina Minnesota United States 55435
    56 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
    57 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
    58 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
    59 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    60 Health Partners Inc Minneapolis Minnesota United States 55454
    61 Regions Hospital Saint Paul Minnesota United States 55101
    62 Lakeview Hospital Stillwater Minnesota United States 55082
    63 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    64 Siteman Cancer Center at West County Hospital Creve Coeur Missouri United States 63141
    65 Parkland Health Center - Farmington Farmington Missouri United States 63640
    66 Research Medical Center Kansas City Missouri United States 64132
    67 Washington University School of Medicine Saint Louis Missouri United States 63110
    68 Siteman Cancer Center-South County Saint Louis Missouri United States 63129
    69 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    70 Siteman Cancer Center at Christian Hospital Saint Louis Missouri United States 63136
    71 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    72 Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri United States 63376
    73 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri United States 63670
    74 Missouri Baptist Sullivan Hospital Sullivan Missouri United States 63080
    75 Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri United States 63127
    76 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    77 Saint Barnabas Medical Center Livingston New Jersey United States 07039
    78 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08903
    79 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
    80 NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    81 Sanford Broadway Medical Center Fargo North Dakota United States 58122
    82 Sanford Roger Maris Cancer Center Fargo North Dakota United States 58122
    83 MetroHealth Medical Center Cleveland Ohio United States 44109
    84 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    85 Legacy Mount Hood Medical Center Gresham Oregon United States 97030
    86 Providence Newberg Medical Center Newberg Oregon United States 97132
    87 Legacy Good Samaritan Hospital and Medical Center Portland Oregon United States 97210
    88 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    89 Kaiser Permanente Northwest Portland Oregon United States 97227
    90 Legacy Meridian Park Hospital Tualatin Oregon United States 97062
    91 Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania United States 18103
    92 Geisinger Medical Center Danville Pennsylvania United States 17822
    93 Reading Hospital West Reading Pennsylvania United States 19611
    94 Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota United States 57104
    95 Avera Cancer Institute Sioux Falls South Dakota United States 57105
    96 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    97 University of Vermont Medical Center Burlington Vermont United States 05401
    98 University of Vermont and State Agricultural College Burlington Vermont United States 05405
    99 Virginia Mason Medical Center Seattle Washington United States 98101
    100 Legacy Cancer Institute Medical Oncology and Day Treatment Vancouver Washington United States 98684
    101 Legacy Salmon Creek Hospital Vancouver Washington United States 98686
    102 Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin United States 53105
    103 Aurora Health Care Germantown Health Center Germantown Wisconsin United States 53022
    104 Aurora Cancer Care-Grafton Grafton Wisconsin United States 53024
    105 Aurora BayCare Medical Center Green Bay Wisconsin United States 54311
    106 Aurora Cancer Care-Kenosha South Kenosha Wisconsin United States 53142
    107 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
    108 Aurora Cancer Care-Milwaukee Milwaukee Wisconsin United States 53209
    109 Aurora Saint Luke's Medical Center Milwaukee Wisconsin United States 53215
    110 Aurora Sinai Medical Center Milwaukee Wisconsin United States 53233
    111 ProHealth D N Greenwald Center Mukwonago Wisconsin United States 53149
    112 Cancer Center of Western Wisconsin New Richmond Wisconsin United States 54017
    113 ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin United States 53066
    114 Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin United States 54904
    115 Aurora Cancer Care-Racine Racine Wisconsin United States 53406
    116 Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin United States 53081
    117 Aurora Medical Center in Summit Summit Wisconsin United States 53066
    118 UW Cancer Center at ProHealth Care Waukesha Wisconsin United States 53188
    119 Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin United States 53226
    120 Aurora West Allis Medical Center West Allis Wisconsin United States 53227

    Sponsors and Collaborators

    • NRG Oncology
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Fabio M Iwamoto, NRG Oncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NRG Oncology
    ClinicalTrials.gov Identifier:
    NCT05095376
    Other Study ID Numbers:
    • NRG-BN011
    • NCI-2021-10331
    • NRG-BN011
    • NRG-BN011
    • U10CA180868
    First Posted:
    Oct 27, 2021
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 12, 2022