BALANCE: BIOMARKER TRIAL of APALUTAMIDE and RADIATION for RECURRENT PROSTATE CANCER

Sponsor
NRG Oncology (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03371719
Collaborator
National Cancer Institute (NCI) (NIH)
311
363
2
126.2
0.9
0

Study Details

Study Description

Brief Summary

This phase II trial studies how well radiation therapy with or without apalutamide works in treating patients with stage III-IV prostate cancer. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgen can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may lessen the amount of androgen made by the body. Giving radiation therapy and apalutamide may work better at treating prostate cancer than radiation alone.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

PRIMARY OBJECTIVES:
  1. To determine whether, in men with post-prostatectomy PSA recurrences, salvage radiation (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone.
SECONDARY OBJECTIVES:
  1. To assess whether molecular stratification by the PAM50 gene expression clustering will identify subsets of prostate cancer (luminal A or basal, luminal B) which derive the greatest benefit from anti-androgen therapy.

  2. To assess overall survival. III. To assess cancer-specific mortality. IV. To assess metastasis-free survival. V. To assess distant metastasis. VI. To assess local-regional progression. VII. To assess PSA nadir during first year of treatment and prior to initiation of any hormonal salvage therapy.

  3. To assess initiation of salvage hormonal therapy. IX. To assess PSA with a non-castrate testosterone at 1 and 3 years post randomization: PSA < 0.1 ng/ml and testosterone >= 50 ng/dl.

  4. To assess acute and late physician-reported morbidity (per the Common Terminology Criteria for Adverse Events [CTCAE] version 5) after SRT +/- apalutamide.

  5. To assess acute and late patient-reported morbidity (per the patient reported outcomes [PRO]-CTCAE) after SRT +/- apalutamide.

  6. To assess testosterone levels at 3, 6, 9, 12, and 36 months post randomization.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients undergo external beam radiation therapy on Day 1 for 7.5 weeks. Beginning on Day 1 of radiation therapy, patients receive placebo orally (PO) once daily (QD) on days 1-30. Treatment repeats every 30 days for up to 6 courses (6 months) in the absence of disease progression or unacceptable toxicity.

ARM 2: Patients undergo external beam radiation therapy on Day 1 for 7.5 weeks. Beginning on Day 1 of radiation therapy, patients receive apalutamide PO QD on Days 1-30. Treatment repeats every 30 days for up to 6 courses (6 months) in the absence of disease progression or unacceptable toxicity.

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

Study Design

Study Type:
Interventional
Actual Enrollment :
311 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase II, Double-Blinded, Placebo Controlled Randomized Trial of Salvage Radiotherapy With or Without Enhanced Anti-androgen Therapy With Apalutamide in Recurrent Prostate Cancer
Actual Study Start Date :
Apr 27, 2018
Anticipated Primary Completion Date :
Feb 16, 2024
Anticipated Study Completion Date :
Oct 31, 2028

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Arm 1 (Radiation Therapy + Placebo)

Patients undergo external beam radiation therapy on Day 1 for 7.5 weeks. Beginning on Day 1 of radiation therapy, patients receive placebo PO QD on Days 1-30. Treatment repeats every 30 days for up to 6 courses (6 months) in the absence of disease progression or unacceptable toxicity.

Radiation: External Beam Radiation Therapy
Undergo external beam radiation therapy
Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation
  • Other: Placebo
    Given PO
    Other Names:
  • placebo therapy
  • PLCB
  • sham therapy
  • Experimental: Arm 2 (Radiation Therapy + Apalutamide)

    Patients undergo external beam radiation therapy on Day 1 for 7.5 weeks. Beginning on Day 1 of radiation therapy, patients receive apalutamide PO QD on Days 1-30. Treatment repeats every 30 days for up to 6 courses (6 months)in the absence of disease progression or unacceptable toxicity.

    Drug: Apalutamide
    Given PO
    Other Names:
  • ARN 509
  • ARN-509
  • ARN509
  • JNJ 56021927
  • JNJ-56021927
  • Radiation: External Beam Radiation Therapy
    Undergo external beam radiation therapy
    Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation
  • Outcome Measures

    Primary Outcome Measures

    1. Biochemical Progression-free survival (bPFS) [From randomization to the first occurrence of a rise in PSA, clinical or radiographic local, regional, or distant metastases, or death from any cause, assessed up to 6 years]

      bPFS curves will be estimated by the Kaplan-Meier (1958) method and compared between the two treatment arms using a one-sided logrank test at the alpha = 0.12 significance level. Analysis will include evaluation of a potential predictive biomarker (molecular subtype) to inform the design of a subsequent, phase III clinical trial. In addition, a multivariable Cox (1972) regression model will be fit incorporating the three stratification factors used in the randomization (surgical margins, pre-salvage radiation (SRT) PSA, and molecular subtype) as covariates to estimate the adjusted hazard ratio (HR) between the two treatment groups. Additional regression models will be fit including other pretreatment characteristics as covariates.

    Secondary Outcome Measures

    1. Acute Patient-Reported Morbidity (per the patient reported outcomes [PRO]- Common Terminology Criteria for Adverse Events [CTCAE]) [Up to 30 days after radiation therapy]

      Adverse events will also be assessed using PRO-CTCAE items. Assessments will be collected before and at the end of radiotherapy treatment and in follow-up. For each symptom and each domain (i.e., frequency, severity, and interference), 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.

    2. Acute Physician-Reported Morbidity (per the Common Terminology Criteria for Adverse Events [CTCAE] version 5) [Up to 30 days after radiation therapy]

      Adverse events will be scored according to the National Cancer Institute (NCI)'s CTCAE version 5.0. For each type of adverse event, frequencies will be provided for the worst grade experienced by the patient by treatment arm. The proportion of patients with grades >= 1 and >= 3 will be compared between groups using a chi-square test, or Fisher's exact test.

    3. Late Patient-Reported Morbidity (per the patient reported outcomes [PRO]- Common Terminology Criteria for Adverse Events [CTCAE]) [From the end of radiation therapy + 30 days up to 6 years]

      Adverse events will also be assessed using PRO-CTCAE items. Assessments will be collected before and at the end of radiotherapy treatment and in follow-up. For each symptom and each domain (i.e., frequency, severity, and interference), 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.

    4. Late Physician-Reported Morbidity (per the Common Terminology Criteria for Adverse Events [CTCAE] version 4) defined as grade 3+ adverse events occurring more than 30 days after the completion of radiation therapy [From the end of radiation therapy + 30 days to the time of the first recorded late grade 3+ adverse event, assessed up to 6 years]

      Adverse events will be scored according to the NCI's CTCAE version 5.0. For each type of adverse event, counts and frequencies will be provided for the worst grade experienced by the patient by treatment arm. The proportion of patients with grades >= 1 and >= 3 will be compared between groups using a chi-square test, or Fisher's exact test.

    5. Cancer-Specific Mortality (CSM) [From the date of randomization to the date of death due to prostate cancer, assessed up to 6 years]

      CSM will be estimated by the Kaplan-Meier method and compared between treatment arms via the logrank test. Patients dying from other causes will be censored as of the date of death. Cox regression will be used to obtain HRs for this outcome, both unadjusted and adjusted for covariates. A competing risks analysis will also be performed treating death from prostate cancer and death from all other causes as competing risks. Cumulative incidence curves will be generated (Gooley et al., 1999; Dignam et al., 2004) along with 95% confidence intervals and compared between the two treatment arms using Gray's method (Gray, 1988).

    6. Distant Metastasis [Up to 6 years]

      Will also be analyzed under a competing risks framework, treating death without experiencing the event in question as a competing risk.

    7. Initiation of Salvage Hormonal Therapy [Up to 6 years]

      Will also be analyzed under a competing risks framework, treating death without experiencing the event in question as a competing risk.

    8. Local-Regional Progression [From randomization to local or regional recurrence, assessed up to 6 years]

      Will also be analyzed under a competing risks framework, treating death without experiencing the event in question as a competing risk.

    9. Metastasis-Free Survival (MFS) [From randomization until distant metastasis (clinical and/or radiographic appearance of disseminated disease) or death from any cause, assessed up to 6 years]

      MFS will be estimated by the Kaplan-Meier method and compared between treatment arms via the logrank test. Cox regression will be used to obtain HRs for this outcome, both unadjusted and adjusted for covariates.

    10. Overall survival (OS) [From randomization until death from any cause, assessed up to 6 years]

      OS will be estimated by the Kaplan-Meier method and compared between treatment arms via the logrank test. Cox regression will be used to obtain HRs for this outcome, both unadjusted and adjusted for covariates.

    11. PSA Nadir During First Year of Treatment and Prior to Initiation of any Hormonal Salvage Therapy [During first year of treatment]

      Will be compared between the two groups using a two-sample t-test.

    12. Testosterone Levels [Every 3 months until 36 months post randomization]

      Testosterone levels over time will be assessed using mixed effects regression modeling.

    13. Undetectable PSA with a Non-Castrate Testosterone (PSA < 0.1 ng/ml and testosterone >= 50 ng/dl) [1 year]

      The proportion of patients with undetectable PSA and non-castrate testosterone level will be compared between the two treatment arms using chi square tests.

    14. Undetectable PSA with a Non-Castrate testosterone (PSA < 0.1 ng/ml and testosterone >= 50 ng/dl)) [3 years]

      The proportion of patients with undetectable PSA and non-castrate testosterone level will be compared between the two treatment arms using chi square tests.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Pathologically (histologically) proven diagnosis of prostate adenocarcinoma; prostatectomy must have been performed within 10 years prior to Step 1 registration and any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted

    • Post-prostatectomy patients with a detectable serum PSA (≥ 0.1, but ≤ 1.0 ng/mL) at study entry (within 90 days of Step 1 registration) and at least one of the following:

    • Gleason score 7-10 (International Society of Urological Pathology [ISUP] grade group 2 to 5)

    • ISUP grade group:

    • Grade Group 1: Gleason score ≤ 6,

    • Grade Group 2: Gleason score 3 + 4 = 7,

    • Grade Group 3: Gleason score 4 + 3 = 7,

    • Grade Group 4: Gleason score 8,

    • Grade Group 5: Gleason scores 9 and 10

    • = T3a disease

    • Persistent elevation of PSA after prostatectomy measured within 90 days after surgery (PSA never became undetectable) of > 0.04 but < 0.2 ng/mL (PSA nadir)

    • pN0 or pNx

    • History/physical examination within 90 days prior to Step 1 registration

    • Karnofsky performance status of 70-100 within 90 days prior to Step 1 registration

    • Surgical formalin-fixed paraffin-embedded (FFPE) specimen must be available for submission to GenomeDx for genomic analysis on Decipher GRID platform; Note: if Decipher results have already been obtained, in lieu of tissue, results must be submitted to GenomeDx for validation

    • Prior androgen deprivation therapy (luteinizing hormone-releasing hormone [LHRH] agonist and/or non-steroidal anti-androgen) is allowed if discontinued at least 90 days prior to Step 1 registration and given for ≤ 90 days duration

    • For example: patients on prior LHRH analogs (post-prostatectomy), the discontinuation date should be calculated based on the expected duration of the sustained release injection, not simply the injection date of the drug; for instance, if a 22.5 mg sustained release dose of leuprolide acetate is given (3 month duration), then the expected duration of such a dose would be 90 days after the injection date; for a 7.5 mg leuprolide (1 month duration), the discontinuation date would be 30 days after the injection date

    • Please note: finasteride or dutasteride must be stopped before treatment starts but prior usage will not affect eligibility

    • Hemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors within 90 days prior to Step 1 registration

    • Platelet count ≥ 100,000 x 10^9/uL independent of transfusion and/or growth factors within 90 days prior to step 1 registration

    • Serum albumin ≥ 3.0 g/dL within 90 days prior to Step 1 registration

    • Glomerular filtration rate (GFR) ≥ 35 mL/min estimated by Cockcroft-Gault or measured directly by 24 hour urine creatinine within 90 days prior to Step 1 registration

    • Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (Note: in subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject is eligible) within 90 days prior to Step 1 registration

    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 x ULN within 90 days prior to Step 1 registration

    • Testosterone > 50 ng/dL within 90 days prior to Step 1 registration

    • Concomitant medications known to lower the seizure threshold discontinued or substituted at least 4 weeks (30 days) prior to Step 1 registration.

    • The patient must agree to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agree to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug

    • The patient must agree not to donate sperm during the study treatment and for 3 months after receiving the last dose of study drug

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

    Exclusion Criteria:
    • Definitive clinical, radiologic, or pathologic evidence of metastatic disease (M1) or lymph node involvement (N1)

    • Prior invasive malignancy (except non-melanomatous skin cancer, carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 years

    • 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

    • History of any of the following:

    • Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year prior to Step 1 registration)

    • History of documented inflammatory bowel disease

    • Transmural myocardial infarction within the last 4 months prior to Step 1 registration.

    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to Step 1 registration

    • History of any condition that in the opinion of the investigator, would preclude participation in this study

    • Current evidence of any of the following:

    • Known gastrointestinal disorder affecting absorption of oral medications

    • Active uncontrolled infection (eg, human immunodeficiency virus [HIV] or viral hepatitis)

    • Uncontrolled hypertension

    • Any current condition that in the opinion of the investigator, would preclude participation in this study

    • Prior whole gland ablative therapy (i.e. cryoablation or high intensity focused ultrasound [HIFU]) for prostate cancer is not allowed

    • HIV positive with CD4 count < 200 cells/microliter within 30 days prior to registration

    • HIV patients under treatment with highly active antiretroviral therapy (HAART) within 30 days prior to registration regardless of CD4 count. (Note: HIV testing is not required for eligibility for this protocol as it is self-reported.)

    • For patients who have not undergone prior Decipher analysis, submission of the specimen to GenomeDx should be as soon as possible after study registration (Step 1) as these results can take up 21 days after the specimen is received at GenomeDx; Step 2 registration must occur within 6 weeks (42 days) of Step 1 registration; if Decipher results have already been obtained, in lieu of tissue, results must be submitted to GenomeDx for validation

    • Patients must not plan to participate in any other clinical trials while receiving treatment on this study or being followed post-protocol therapy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Breast Cancer Specialists-Gilbert Gilbert Arizona United States 85297
    2 Arizona Center for Cancer Care-Peoria Peoria Arizona United States 85381
    3 Arizona Breast Cancer Specialists-Scottsdale Scottsdale Arizona United States 85258
    4 Arizona Center for Cancer Care-Surprise Surprise Arizona United States 85374
    5 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    6 Alta Bates Summit Medical Center-Herrick Campus Berkeley California United States 94704
    7 Marin General Hospital Greenbrae California United States 94904
    8 Los Angeles County-USC Medical Center Los Angeles California United States 90033
    9 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033
    10 Cedars Sinai Medical Center Los Angeles California United States 90048
    11 Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California United States 95661
    12 Sutter Medical Center Sacramento Sacramento California United States 95816
    13 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    14 Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee California United States 96161
    15 Sutter Solano Medical Center/Cancer Center Vallejo California United States 94589
    16 University of Colorado Hospital Aurora Colorado United States 80045
    17 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
    18 UCHealth Memorial Hospital Central Colorado Springs Colorado United States 80909
    19 Memorial Hospital North Colorado Springs Colorado United States 80920
    20 Poudre Valley Hospital Fort Collins Colorado United States 80524
    21 Cancer Care and Hematology-Fort Collins Fort Collins Colorado United States 80528
    22 Valley View Hospital Cancer Center Glenwood Springs Colorado United States 81601
    23 UCHealth Greeley Hospital Greeley Colorado United States 80631
    24 Medical Center of the Rockies Loveland Colorado United States 80538
    25 Stamford Hospital/Bennett Cancer Center Stamford Connecticut United States 06904
    26 Helen F Graham Cancer Center Newark Delaware United States 19713
    27 Christiana Care Health System-Christiana Hospital Newark Delaware United States 19718
    28 Beebe Health Campus Rehoboth Beach Delaware United States 19971
    29 George Washington University Medical Center Washington District of Columbia United States 20037
    30 AdventHealth Altamonte Altamonte Springs Florida United States 32701
    31 Regional Cancer Center-Lee Memorial Health System Fort Myers Florida United States 33905
    32 AdventHealth Kissimmee Kissimmee Florida United States 34744
    33 AdventHealth Orlando Orlando Florida United States 32803
    34 AdventHealth East Orlando Orlando Florida United States 32822
    35 Cleveland Clinic-Weston Weston Florida United States 33331
    36 AdventHealth Winter Park Winter Park Florida United States 32792
    37 Grady Health System Atlanta Georgia United States 30303
    38 Emory University Hospital Midtown Atlanta Georgia United States 30308
    39 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322
    40 Emory Saint Joseph's Hospital Atlanta Georgia United States 30342
    41 Northside Hospital Atlanta Georgia United States 30342
    42 Augusta University Medical Center Augusta Georgia United States 30912
    43 Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia United States 31405
    44 Saint Luke's Cancer Institute - Boise Boise Idaho United States 83712
    45 Saint Luke's Cancer Institute - Fruitland Fruitland Idaho United States 83619
    46 Saint Luke's Cancer Institute - Meridian Meridian Idaho United States 83642
    47 Saint Luke's Cancer Institute - Nampa Nampa Idaho United States 83686
    48 Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho United States 83301
    49 Rush University Medical Center Chicago Illinois United States 60612
    50 University of Illinois Chicago Illinois United States 60612
    51 Decatur Memorial Hospital Decatur Illinois United States 62526
    52 Crossroads Cancer Center Effingham Illinois United States 62401
    53 Edward Hines Jr VA Hospital Hines Illinois United States 60141
    54 Loyola University Medical Center Maywood Illinois United States 60153
    55 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    56 OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois United States 61615
    57 OSF Saint Francis Medical Center Peoria Illinois United States 61637
    58 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    59 Springfield Clinic Springfield Illinois United States 62702
    60 Memorial Medical Center Springfield Illinois United States 62781
    61 Carle Cancer Center Urbana Illinois United States 61801
    62 Parkview Hospital Randallia Fort Wayne Indiana United States 46805
    63 Parkview Regional Medical Center Fort Wayne Indiana United States 46845
    64 Goshen Center for Cancer Care Goshen Indiana United States 46526
    65 Reid Health Richmond Indiana United States 47374
    66 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa United States 50325
    67 Mercy Cancer Center-West Lakes Clive Iowa United States 50325
    68 Greater Regional Medical Center Creston Iowa United States 50801
    69 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
    70 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    71 Mercy Medical Center-West Lakes West Des Moines Iowa United States 50266
    72 University of Kansas Cancer Center Kansas City Kansas United States 66160
    73 Olathe Health Cancer Center Olathe Kansas United States 66061
    74 University of Kansas Cancer Center-Overland Park Overland Park Kansas United States 66210
    75 Salina Regional Health Center Salina Kansas United States 67401
    76 University of Kansas Hospital-Westwood Cancer Center Westwood Kansas United States 66205
    77 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
    78 Mary Bird Perkins Cancer Center Baton Rouge Louisiana United States 70809
    79 East Jefferson General Hospital Metairie Louisiana United States 70006
    80 LSU Healthcare Network / Metairie Multi-Specialty Clinic Metairie Louisiana United States 70006
    81 MaineHealth Coastal Cancer Treatment Center Bath Maine United States 04530
    82 Waldo County General Hospital Belfast Maine United States 04915
    83 MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford Biddeford Maine United States 04005
    84 Lafayette Family Cancer Center-EMMC Brewer Maine United States 04412
    85 Stephens Memorial Hospital Norway Maine United States 04268
    86 Maine Medical Center-Bramhall Campus Portland Maine United States 04102
    87 Penobscot Bay Medical Center Rockport Maine United States 04856
    88 MaineHealth Cancer Care Center of York County Sanford Maine United States 04073
    89 MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford Sanford Maine United States 04073
    90 Maine Medical Center- Scarborough Campus Scarborough Maine United States 04074
    91 Maine Medical Partners - South Portland South Portland Maine United States 04106
    92 University of Maryland/Greenebaum Cancer Center Baltimore Maryland United States 21201
    93 Saint Agnes Hospital Baltimore Maryland United States 21229
    94 Central Maryland Radiation Oncology in Howard County Columbia Maryland United States 21044
    95 UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie Maryland United States 21061
    96 Lahey Hospital and Medical Center Burlington Massachusetts United States 01805
    97 Lowell General Hospital Lowell Massachusetts United States 01854
    98 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    99 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
    100 Bronson Battle Creek Battle Creek Michigan United States 49017
    101 Saint Joseph Mercy Brighton Brighton Michigan United States 48114
    102 Saint Joseph Mercy Canton Canton Michigan United States 48188
    103 Saint Joseph Mercy Chelsea Chelsea Michigan United States 48118
    104 GenesisCare USA - Clarkston Clarkston Michigan United States 48346
    105 Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan United States 48038
    106 Beaumont Hospital - Dearborn Dearborn Michigan United States 48124
    107 Henry Ford Hospital Detroit Michigan United States 48202
    108 Michigan State University Clinical Center East Lansing Michigan United States 48824-7016
    109 GenesisCare USA - Farmington Hills Farmington Hills Michigan United States 48334
    110 Mercy Health Saint Mary's Grand Rapids Michigan United States 49503
    111 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
    112 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    113 Sparrow Hospital Lansing Michigan United States 48912
    114 Lakeland Hospital Niles Niles Michigan United States 49120
    115 Spectrum Health Reed City Hospital Reed City Michigan United States 49677
    116 William Beaumont Hospital-Royal Oak Royal Oak Michigan United States 48073
    117 Lakeland Medical Center Saint Joseph Saint Joseph Michigan United States 49085
    118 Marie Yeager Cancer Center Saint Joseph Michigan United States 49085
    119 Munson Medical Center Traverse City Michigan United States 49684
    120 William Beaumont Hospital - Troy Troy Michigan United States 48085
    121 GenesisCare USA - Troy Troy Michigan United States 48098
    122 Henry Ford West Bloomfield Hospital West Bloomfield Michigan United States 48322
    123 Metro Health Hospital Wyoming Michigan United States 49519
    124 Mayo Clinic Health System in Albert Lea Albert Lea Minnesota United States 56007
    125 Fairview Ridges Hospital Burnsville Minnesota United States 55337
    126 Mercy Hospital Coon Rapids Minnesota United States 55433
    127 Fairview Southdale Hospital Edina Minnesota United States 55435
    128 Unity Hospital Fridley Minnesota United States 55432
    129 Mayo Clinic Health Systems-Mankato Mankato Minnesota United States 56001
    130 Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota United States 55369
    131 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
    132 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
    133 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
    134 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    135 Minneapolis VA Medical Center Minneapolis Minnesota United States 55417
    136 Health Partners Inc Minneapolis Minnesota United States 55454
    137 Monticello Cancer Center Monticello Minnesota United States 55362
    138 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
    139 Mayo Clinic in Rochester Rochester Minnesota United States 55905
    140 Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota United States 56303
    141 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
    142 Regions Hospital Saint Paul Minnesota United States 55101
    143 United Hospital Saint Paul Minnesota United States 55102
    144 Saint Francis Regional Medical Center Shakopee Minnesota United States 55379
    145 Lakeview Hospital Stillwater Minnesota United States 55082
    146 Ridgeview Medical Center Waconia Minnesota United States 55387
    147 Rice Memorial Hospital Willmar Minnesota United States 56201
    148 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
    149 Fairview Lakes Medical Center Wyoming Minnesota United States 55092
    150 University of Mississippi Medical Center Jackson Mississippi United States 39216
    151 Southeast Cancer Center Cape Girardeau Missouri United States 63703
    152 Siteman Cancer Center at West County Hospital Creve Coeur Missouri United States 63141
    153 Capital Region Southwest Campus Jefferson City Missouri United States 65109
    154 Kansas City Veterans Affairs Medical Center Kansas City Missouri United States 64128
    155 University of Kansas Cancer Center - North Kansas City Missouri United States 64154
    156 University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri United States 64064
    157 Delbert Day Cancer Institute at PCRMC Rolla Missouri United States 65401
    158 Washington University School of Medicine Saint Louis Missouri United States 63110
    159 Siteman Cancer Center-South County Saint Louis Missouri United States 63129
    160 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    161 Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri United States 63376
    162 Billings Clinic Cancer Center Billings Montana United States 59101
    163 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    164 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    165 Nebraska Methodist Hospital Omaha Nebraska United States 68114
    166 Alegent Health Bergan Mercy Medical Center Omaha Nebraska United States 68124
    167 University of Nebraska Medical Center Omaha Nebraska United States 68198
    168 Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada United States 89052
    169 Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson Nevada United States 89052
    170 Las Vegas Cancer Center-Henderson Henderson Nevada United States 89052
    171 OptumCare Cancer Care at Seven Hills Henderson Nevada United States 89052
    172 21st Century Oncology-Henderson Henderson Nevada United States 89074
    173 Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson Nevada United States 89074
    174 Desert West Surgery Las Vegas Nevada United States 89102
    175 OptumCare Cancer Care at Charleston Las Vegas Nevada United States 89102
    176 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
    177 Hope Cancer Care of Nevada Las Vegas Nevada United States 89103
    178 Radiation Oncology Centers of Nevada Central Las Vegas Nevada United States 89106
    179 21st Century Oncology Las Vegas Nevada United States 89109
    180 HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Las Vegas Nevada United States 89109
    181 HealthCare Partners Medical Group Oncology/Hematology-San Martin Las Vegas Nevada United States 89113
    182 Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada United States 89119
    183 Cancer Therapy and Integrative Medicine Las Vegas Nevada United States 89121
    184 21st Century Oncology-Vegas Tenaya Las Vegas Nevada United States 89128
    185 Ann M Wierman MD LTD Las Vegas Nevada United States 89128
    186 Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada United States 89128
    187 HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas Nevada United States 89128
    188 OptumCare Cancer Care at MountainView Las Vegas Nevada United States 89128
    189 Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada United States 89144
    190 Summerlin Hospital Medical Center Las Vegas Nevada United States 89144
    191 Las Vegas Cancer Center-Medical Center Las Vegas Nevada United States 89148-2405
    192 21st Century Oncology-Fort Apache Las Vegas Nevada United States 89148
    193 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89148
    194 OptumCare Cancer Care at Fort Apache Las Vegas Nevada United States 89148
    195 HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Las Vegas Nevada United States 89149
    196 Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada United States 89169
    197 University Cancer Center Las Vegas Nevada United States 89169
    198 Hope Cancer Care of Nevada-Pahrump Pahrump Nevada United States 89048
    199 Radiation Oncology Associates Reno Nevada United States 89509
    200 New Hampshire Oncology Hematology PA-Concord Concord New Hampshire United States 03301
    201 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    202 Solinsky Center for Cancer Care Manchester New Hampshire United States 03103
    203 Virtua Memorial Mount Holly New Jersey United States 08060
    204 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08903
    205 Sidney Kimmel Cancer Center Washington Township Sewell New Jersey United States 08080
    206 Robert Wood Johnson University Hospital Somerset Somerville New Jersey United States 08876
    207 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
    208 New Mexico Oncology Hematology Consultants Albuquerque New Mexico United States 87109
    209 James J Peters VA Medical Center Bronx New York United States 10468
    210 New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn New York United States 11215
    211 Sands Cancer Center Canandaigua New York United States 14424
    212 Mary Imogene Bassett Hospital Cooperstown New York United States 13326
    213 Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York United States 10016
    214 Wilmot Cancer Institute Radiation Oncology at Greece Rochester New York United States 14606
    215 Highland Hospital Rochester New York United States 14620
    216 University of Rochester Rochester New York United States 14642
    217 Stony Brook University Medical Center Stony Brook New York United States 11794
    218 State University of New York Upstate Medical University Syracuse New York United States 13210
    219 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
    220 NHRMC Radiation Oncology - Supply Supply North Carolina United States 28462
    221 New Hanover Regional Medical Center/Zimmer Cancer Center Wilmington North Carolina United States 28401
    222 NHRMC Radiation Oncology - 16th Street Wilmington North Carolina United States 28401
    223 Summa Health System - Akron Campus Akron Ohio United States 44304
    224 Cleveland Clinic Akron General Akron Ohio United States 44307
    225 UHHS-Chagrin Highlands Medical Center Beachwood Ohio United States 44122
    226 Indu and Raj Soin Medical Center Beavercreek Ohio United States 45431
    227 Dayton Physicians LLC-Miami Valley South Centerville Ohio United States 45459
    228 Miami Valley Hospital South Centerville Ohio United States 45459
    229 Geauga Hospital Chardon Ohio United States 44024
    230 University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio United States 45219
    231 Oncology Hematology Care Inc-Kenwood Cincinnati Ohio United States 45236
    232 Case Western Reserve University Cleveland Ohio United States 44106
    233 Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio United States 44111
    234 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    235 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    236 The Mark H Zangmeister Center Columbus Ohio United States 43219
    237 Good Samaritan Hospital - Dayton Dayton Ohio United States 45406
    238 Miami Valley Hospital Dayton Ohio United States 45409
    239 Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio United States 45415
    240 Miami Valley Hospital North Dayton Ohio United States 45415
    241 Armes Family Cancer Center Findlay Ohio United States 45840
    242 Blanchard Valley Hospital Findlay Ohio United States 45840
    243 Orion Cancer Care Findlay Ohio United States 45840
    244 Atrium Medical Center-Middletown Regional Hospital Franklin Ohio United States 45005-1066
    245 Dayton Physicians LLC-Atrium Franklin Ohio United States 45005
    246 Dayton Physicians LLC-Wayne Greenville Ohio United States 45331
    247 Wayne Hospital Greenville Ohio United States 45331
    248 Greater Dayton Cancer Center Kettering Ohio United States 45409
    249 First Dayton Cancer Care Kettering Ohio United States 45420
    250 Kettering Medical Center Kettering Ohio United States 45429
    251 Cleveland Clinic Cancer Center Mansfield Mansfield Ohio United States 44906
    252 Hillcrest Hospital Cancer Center Mayfield Heights Ohio United States 44124
    253 UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio United States 44060
    254 UH Seidman Cancer Center at Southwest General Hospital Middleburg Heights Ohio United States 44130
    255 University Hospitals Parma Medical Center Parma Ohio United States 44129
    256 University Hospitals Portage Medical Center Ravenna Ohio United States 44266
    257 North Coast Cancer Care Sandusky Ohio United States 44870
    258 UH Seidman Cancer Center at Firelands Regional Medical Center Sandusky Ohio United States 44870
    259 Springfield Regional Cancer Center Springfield Ohio United States 45504
    260 Springfield Regional Medical Center Springfield Ohio United States 45505
    261 Cleveland Clinic Cancer Center Strongsville Strongsville Ohio United States 44136
    262 Dayton Physicians LLC-Upper Valley Troy Ohio United States 45373
    263 Upper Valley Medical Center Troy Ohio United States 45373
    264 University of Cincinnati Cancer Center-West Chester West Chester Ohio United States 45069
    265 UHHS-Westlake Medical Center Westlake Ohio United States 44145
    266 Cleveland Clinic Wooster Family Health and Surgery Center Wooster Ohio United States 44691
    267 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    268 Cancer Treatment Centers of America Tulsa Oklahoma United States 74133
    269 Legacy Mount Hood Medical Center Gresham Oregon United States 97030
    270 Legacy Good Samaritan Hospital and Medical Center Portland Oregon United States 97210
    271 UPMC Altoona Altoona Pennsylvania United States 16601
    272 UPMC-Heritage Valley Health System Beaver Beaver Pennsylvania United States 15009
    273 Saint Luke's University Hospital-Bethlehem Campus Bethlehem Pennsylvania United States 18015
    274 Christiana Care Health System-Concord Health Center Chadds Ford Pennsylvania United States 19317
    275 Northeast Radiation Oncology Center Dunmore Pennsylvania United States 18512
    276 UPMC Cancer Center at UPMC Horizon Farrell Pennsylvania United States 16121
    277 UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg Pennsylvania United States 15601
    278 UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg Pennsylvania United States 17109
    279 Penn State Milton S Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    280 UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown Pennsylvania United States 15901
    281 UPMC Cancer Center at UPMC McKeesport McKeesport Pennsylvania United States 15132
    282 UPMC Cancer Center - Monroeville Monroeville Pennsylvania United States 15146
    283 UPMC-Coraopolis/Heritage Valley Radiation Oncology Moon Pennsylvania United States 15108
    284 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
    285 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    286 Jefferson Torresdale Hospital Philadelphia Pennsylvania United States 19114
    287 UPMC-Magee Womens Hospital Pittsburgh Pennsylvania United States 15213
    288 UPMC-Saint Margaret Pittsburgh Pennsylvania United States 15215
    289 UPMC-Shadyside Hospital Pittsburgh Pennsylvania United States 15232
    290 UPMC-Passavant Hospital Pittsburgh Pennsylvania United States 15237
    291 UPMC-Saint Clair Hospital Cancer Center Pittsburgh Pennsylvania United States 15243
    292 Guthrie Medical Group PC-Robert Packer Hospital Sayre Pennsylvania United States 18840
    293 UPMC Cancer Center at UPMC Northwest Seneca Pennsylvania United States 16346
    294 UPMC Uniontown Hospital Radiation Oncology Uniontown Pennsylvania United States 15401
    295 UPMC Washington Hospital Radiation Oncology Washington Pennsylvania United States 15301
    296 Reading Hospital West Reading Pennsylvania United States 19611
    297 Asplundh Cancer Pavilion Willow Grove Pennsylvania United States 19090
    298 Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina United States 29316
    299 Prisma Health Cancer Institute - Faris Greenville South Carolina United States 29605
    300 Prisma Health Cancer Institute - Eastside Greenville South Carolina United States 29615
    301 Self Regional Healthcare Greenwood South Carolina United States 29646
    302 Prisma Health Cancer Institute - Greer Greer South Carolina United States 29650
    303 The Radiation Oncology Center-Hilton Head/Bluffton Hilton Head Island South Carolina United States 29926
    304 Prisma Health Cancer Institute - Seneca Seneca South Carolina United States 29672
    305 Rapid City Regional Hospital Rapid City South Dakota United States 57701
    306 The West Clinic - Wolf River Germantown Tennessee United States 38138
    307 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
    308 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
    309 Audie L Murphy VA Hospital San Antonio Texas United States 78229
    310 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
    311 American Fork Hospital / Huntsman Intermountain Cancer Center American Fork Utah United States 84003
    312 Sandra L Maxwell Cancer Center Cedar City Utah United States 84720
    313 Farmington Health Center Farmington Utah United States 84025
    314 Logan Regional Hospital Logan Utah United States 84321
    315 Intermountain Medical Center Murray Utah United States 84107
    316 McKay-Dee Hospital Center Ogden Utah United States 84403
    317 Utah Valley Regional Medical Center Provo Utah United States 84604
    318 Riverton Hospital Riverton Utah United States 84065
    319 Dixie Medical Center Regional Cancer Center Saint George Utah United States 84770
    320 Utah Cancer Specialists-Salt Lake City Salt Lake City Utah United States 84106
    321 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
    322 LDS Hospital Salt Lake City Utah United States 84143
    323 Southwestern Vermont Medical Center Bennington Vermont United States 05201
    324 Central Vermont Medical Center/National Life Cancer Treatment Berlin Vermont United States 05602
    325 University of Vermont Medical Center Burlington Vermont United States 05401
    326 University of Vermont and State Agricultural College Burlington Vermont United States 05405
    327 Norris Cotton Cancer Center-North Saint Johnsbury Vermont United States 05819
    328 Naval Medical Center - Portsmouth Portsmouth Virginia United States 23708-2197
    329 Hunter Holmes McGuire Veterans Administration Medical Center Richmond Virginia United States 23249
    330 PeaceHealth Saint Joseph Medical Center Bellingham Washington United States 98225
    331 Legacy Salmon Creek Hospital Vancouver Washington United States 98686
    332 Providence Saint Mary Regional Cancer Center Walla Walla Washington United States 99362
    333 West Virginia University Healthcare Morgantown West Virginia United States 26506
    334 Camden Clark Medical Center Parkersburg West Virginia United States 26101
    335 Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin United States 54701
    336 Aurora Cancer Care-Grafton Grafton Wisconsin United States 53024
    337 Aurora BayCare Medical Center Green Bay Wisconsin United States 54311
    338 Aurora Cancer Care-Kenosha South Kenosha Wisconsin United States 53142
    339 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    340 Froedtert Menomonee Falls Hospital Menomonee Falls Wisconsin United States 53051
    341 Aurora Saint Luke's Medical Center Milwaukee Wisconsin United States 53215
    342 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    343 Zablocki Veterans Administration Medical Center Milwaukee Wisconsin United States 53295
    344 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
    345 Cancer Center of Western Wisconsin New Richmond Wisconsin United States 54017
    346 Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin United States 54904
    347 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
    348 Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin United States 53081
    349 Marshfield Clinic Stevens Point Center Stevens Point Wisconsin United States 54482
    350 Aurora Medical Center in Summit Summit Wisconsin United States 53066
    351 Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin United States 54241
    352 Aurora West Allis Medical Center West Allis Wisconsin United States 53227
    353 Froedtert West Bend Hospital/Kraemer Cancer Center West Bend Wisconsin United States 53095
    354 Diagnostic and Treatment Center Weston Wisconsin United States 54476
    355 Marshfield Medical Center - Weston Weston Wisconsin United States 54476
    356 Tom Baker Cancer Centre Calgary Alberta Canada T2N 4N2
    357 University Health Network-Princess Margaret Hospital Toronto Ontario Canada M5G 2M9
    358 CIUSSSEMTL-Hopital Maisonneuve-Rosemont Montreal Quebec Canada H1T 2M4
    359 The Research Institute of the McGill University Health Centre (MUHC) Montreal Quebec Canada H3H 2R9
    360 CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) Quebec City Quebec Canada G1R 2J6
    361 Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke Quebec Canada J1H 5N4
    362 Allan Blair Cancer Centre Regina Saskatchewan Canada S4T 7T1
    363 Saskatoon Cancer Centre Saskatoon Saskatchewan Canada S7N 4H4

    Sponsors and Collaborators

    • NRG Oncology
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Daniel Spratt, MD, NRG Oncology
    • Principal Investigator: Felix Feng, MD, NRG Oncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NRG Oncology
    ClinicalTrials.gov Identifier:
    NCT03371719
    Other Study ID Numbers:
    • NRG-GU006
    • NCI-2017-01268
    • NRG-GU006
    • NRG-GU006
    • U10CA180868
    First Posted:
    Dec 13, 2017
    Last Update Posted:
    Mar 11, 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 Mar 11, 2022