A Randomized Study of Olaparib or Placebo in Patients With Surgically Removed Pancreatic Cancer Who Have a BRCA1, BRCA2 or PALB2 Mutation, The APOLLO Trial

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT04858334
Collaborator
(none)
152
343
2
43.1
0.4
0

Study Details

Study Description

Brief Summary

This phase II trial investigates how well the addition of olaparib following completion of surgery and chemotherapy works in treating patients with pancreatic cancer that has been surgically removed (resected) and has a pathogenic mutation in BRCA1, BRCA2, or PALB2. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy.

Detailed Description

PRIMARY OBJECTIVE:
  1. To determine the relapse-free survival (RFS)-benefit from the addition of a maintenance olaparib following completion of chemotherapy in patients with resected pancreatic carcinoma and a pathogenic germline or somatic mutation in BRCA1, BRCA2 or PALB2.
SECONDARY OBJECTIVES:
  1. To evaluate RFS in patients with olaparib after perioperative chemotherapy compared to those treated with perioperative therapy alone among patients who received prior platinum-based perioperative chemotherapy.

  2. To evaluate overall survival (OS) in patients treated with olaparib after adjuvant chemotherapy compared to those treated with adjuvant treatment alone.

  3. To analyze the efficacy of olaparib after chemotherapy in patients with a pathogenic germline BRCA or PALB2 mutation compared to those with a somatic mutation.

  4. To analyze survival differences between patients who received neoadjuvant or perioperative chemotherapy compared to those who received adjuvant therapy alone.

  5. To analyze RFS and OS differences in those who received =< 3 months of perioperative platinum chemotherapy compared to those who received > 3 months of perioperative platinum chemotherapy.

  6. To analyze RFS and OS differences in those who received any platinum-based perioperative chemotherapy compared to no-platinum based perioperative chemotherapy.

EXPLORATORY OBJECTIVES:
  1. To analyze RFS and OS differences in patients who had R1 versus (vs) R0 resections, lymph node positivity at resection, and/or elevated or rising CA 19-9 or CEA at time of study enrollment in the post-operative setting.

  2. To analyze RFS and OS differences with those who had resectable disease at diagnosis compared to those who did not.

  3. To analyze RFS and OS differences in those with gBRCA1 mutations compared to those with gBRCA2 mutations and gPALB2 mutations.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive olaparib orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo PO BID on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, every 4 months for year 1, then every 6 months for years 2-10.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
152 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation
Actual Study Start Date :
Apr 29, 2021
Anticipated Primary Completion Date :
Nov 30, 2024
Anticipated Study Completion Date :
Nov 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (olaparib)

Patients receive olaparib PO BID on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.

Drug: Olaparib
Given PO
Other Names:
  • AZD 2281
  • AZD-2281
  • AZD2281
  • KU-0059436
  • Lynparza
  • PARP Inhibitor AZD2281
  • Placebo Comparator: Arm II (placebo)

    Patients receive placebo PO BID on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.

    Drug: Placebo Administration
    Given PO

    Outcome Measures

    Primary Outcome Measures

    1. Improvement in relapse-free survival (RFS) [From randomization to first documentation of disease recurrence (primary tumor relapse) or death, assessed from 22 months to 44 months]

      Will demonstrate an improvement in the RFS from 22 months to 44 months (hazard ratio 0.5) in patients treated with olaparib after perioperative (neoadjuvant, adjuvant or a combination) chemotherapy compared to those treated with perioperative therapy alone.

    Secondary Outcome Measures

    1. RFS [From randomization to first documentation of disease recurrence (primary tumor relapse) or death, assessed up to 5 years]

      Will evaluate RFS in patients with olaparib after perioperative chemotherapy compared to those treated with perioperative therapy alone. Analysis will be largely exploratory. Within each arm any proportion endpoint (toxicity, mutation rate, etc.) will be estimable with a 95% confidence interval. Arm A would have a confidence interval that is 20 percentage points wide, and Arm B would have a confidence interval that is 29 percentage points wide.

    2. Overall survival (OS) [From randomization until 10 years after registration or until death, whichever comes first]

      Analysis will be largely exploratory. Power for overall survival in particular will be limited. Within each arm any proportion endpoint (toxicity, mutation rate, etc.) will be estimable with a 95% confidence interval. Arm A would have a confidence interval that is 20 percentage points wide, and Arm B would have a confidence interval that is 29 percentage points wide.

    3. Efficacy of olaparib after chemotherapy in patients with a pathogenic germline BRCA or PALB2 mutation [Up to 10 years]

      Will analyze the efficacy of olaparib after chemotherapy in patients with a pathogenic germline BRCA or PALB2 mutation compared to those with a somatic mutation.

    4. Differences in survival [Up to 10 years]

      Will analyze survival differences between patients who received neoadjuvant or perioperative chemotherapy compared to those who received adjuvant therapy alone.

    5. RFS in those who received =< 3 months of perioperative platinum chemotherapy compared to > 3 months of perioperative platinum chemotherapy [From randomization to first documentation of disease recurrence (primary tumor relapse) or death, assessed up to 5 years]

      Analysis will be largely exploratory. Within each arm any proportion endpoint (toxicity, mutation rate, etc.) will be estimable with a 95% confidence interval. Arm A would have a confidence interval that is 20 percentage points wide, and Arm B would have a confidence interval that is 29 percentage points wide.

    6. OS in those who received =< 3 months of perioperative platinum chemotherapy versus > 3 months of perioperative platinum chemotherapy [From randomization until 10 years after registration or until death, whichever comes first]

      Analysis will be largely exploratory. Power for overall survival in particular will be limited. Within each arm any proportion endpoint (toxicity, mutation rate, etc.) will be estimable with a 95% confidence interval. Arm A would have a confidence interval that is 20 percentage points wide, and Arm B would have a confidence interval that is 29 percentage points wide.

    7. RFS in those who received any platinum-based perioperative chemotherapy versus no platinum-based perioperative chemotherapy [From randomization to first documentation of disease recurrence (primary tumor relapse) or death, assessed up to 5 years]

      Analysis will be largely exploratory. Within each arm any proportion endpoint (toxicity, mutation rate, etc.) will be estimable with a 95% confidence interval. Arm A would have a confidence interval that is 20 percentage points wide, and Arm B would have a confidence interval that is 29 percentage points wide.

    8. OS in those who received any platinum-based perioperative chemotherapy versus no platinum-based perioperative chemotherapy [From randomization until 10 years after registration or until death, whichever comes first]

      Analysis will be largely exploratory. Power for overall survival in particular will be limited. Within each arm any proportion endpoint (toxicity, mutation rate, etc.) will be estimable with a 95% confidence interval. Arm A would have a confidence interval that is 20 percentage points wide, and Arm B would have a confidence interval that is 29 percentage points wide.

    Other Outcome Measures

    1. RFS and OS differences in patients who had R1 vs R0 resections [At time of study enrollment]

    2. RFS and OS differences in patients who had lymph node positivity at resection [At time of study enrollment]

    3. RFS and OS differences in patients who had elevated or rising CA 19-9 or CEA [At time of study enrollment]

      A cutoff of 35 will be used to determine elevated versus normal CA 19-9 (i.e., greater than 35 will be considered elevated), and the cutoff for CEA will be based on the treating institution's definition of the upper limit of normal. Univariate differences by marker status will be analyzed and Cox proportional hazards models will be fit, adjusting for other clinical and demographic factors that may be confounders.

    4. RFS and OS differences with those who had resectable disease at diagnosis [Up to 10 years]

      Will be compared to those who did not.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • STEP 0 (PRE-REGISTRATION) INCLUSION CRITERIA

    • Patient must be >= 18 years of age on day of consent

    • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

    • Patient must have a diagnosis of pancreatic cancer and have successfully undergone a curative intent surgical resection and must have no evidence of recurrent disease as determined by the investigator

    • NOTE: This includes patients with adenocarcinoma, acinar carcinoma, squamous cell carcinoma adenosquamous and variants thereof. Patients with neuroendocrine tumors are excluded from enrolling

    • Patient must (1) be planning to receive, (2) be receiving or (3) have received at least three combined months (i.e., 12 weeks) of perioperative (neoadjuvant, adjuvant or a combination of both) systemic, multi-agent chemotherapy. Patients may have had up to 6 months of perioperative systemic therapy as deemed appropriate by their primary treating medical team (patients can have received radiation or chemoradiation in addition to this 6 month course)

    • Patient must be no more than 12 weeks from their most recent treatment (this may be chemotherapy, radiotherapy or surgery)

    • Patient must have a known pathogenic or likely pathogenic germline or somatic mutation in BRCA1, BRCA2, or PALB2, as determined by a Clinical Laboratory Improvement Amendments (CLIA) certified or equivalently-accredited laboratory. Mutations must be considered pathogenic or likely pathogenic by a reference database such as ClinVar or OncoKb.org

    • STEP 1 (RANDOMIZATION) INCLUSION CRITERIA

    • Patient must have met the eligibility criteria outlined above

    • Patient must have undergone at least 3 combined months (i.e., 12 weeks) of perioperative (neoadjuvant, adjuvant or a combination of both) systemic, multi-agent chemotherapy. Patients may have had up to 6 months of perioperative systemic therapy as deemed appropriate by their primary treating medical team (patients can have received radiation or chemoradiation in addition to this 6 months course)

    • Central expert reviewer must have determined the patient eligible for randomization after review of local genetic testing reports

    • If mutation in BRCA1, BRCA2 or PALB2 was identified in tumor tissue and the patient has not previously undergone germline testing, the patient must agree to undergo germline testing

    • Patient must not have previously had evidence of progressive pancreatic cancer while receiving platinum-based therapy

    • Patient must be >= 21 days (three weeks) from their last treatment (including chemotherapy radiotherapy or surgery) but =< 84 days (twelve weeks) from their last treatment at the time of Step 1 randomization. Patients who have received neoadjuvant and/or adjuvant radiotherapy are eligible

    • Patient must have recovered from any adverse events due to prior anti-cancer therapy (i.e., have no residual toxicities > grade 1 with the exception of alopecia and/or neuropathy)

    • Leukocytes >= 3,000/mcL (obtained =< 28 days prior to Step 1 randomization)

    • Absolute neutrophil count >= 1,500/mcL (obtained =< 28 days prior to Step 1 randomization)

    • Platelets >= 100,000/mcL (obtained =< 28 days prior to Step 1 randomization)

    • Hemoglobin >= 9.0 g/dL with no blood transfusion in the past 28 days (obtained =< 28 days prior to Step 1 randomization)

    • Total bilirubin =< institutional upper limit of normal (ULN) except in patients with Gilbert's syndrome. Patients with Gilbert's syndrome may enroll if direct bilirubin =< 2.5 ULN of the direct bilirubin (obtained =< 28 days prior to Step 1 randomization)

    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 institutional ULN (obtained =< 28 days prior to Step 1 randomization)

    • Creatinine =< institutional ULN OR calculated Cockcroft Gault creatinine clearance > 50 mL/min/1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m2 (obtained =< 28 days prior to Step 1 randomization)

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

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

    • 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

    • Patient must have the ability to understand the willingness to sign a written informed consent document, or have legally authorized representative provide authorization to participate

    Exclusion Criteria:
    • STEP 1 (RANDOMIZATION) EXCLUSION CRITERIA

    • Patient must have no evidence of recurrent or metastatic pancreatic cancer at the time of randomization as documented by baseline scans obtained =< 4 weeks prior to Step 1 randomization

    • Patient must not be receiving any other investigational agents at the time of Step 1 randomization and while on protocol treatment

    • Patient must not have any history of allergic reactions attributed to compounds of similar chemical or biological composition to olaparib

    • Patient must not have any personal history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML.

    • Patient must not have any uncontrolled gastrointestinal disorder that would, in the opinion of the investigator, interfere with the ingestion or absorption of olaparib

    • Patient must not be pregnant or breast-feeding due the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to Step 1 randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

    • Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 6 months after the last dose of protocol treatment for female patients and for 3 months after the last dose of protocol treatment for male patients. Patients must also not donate sperm while on protocol treatment and for 3 months after the last dose of protocol treatment. Patients must also not breast-feed while on protocol treatment and for 1 month after the last dose of protocol treatment

    • Patient must not have resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g. unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, corrected QT (QTc) prolongation > 500 ms, electrolyte disturbances, etc.) or have congenital long QT syndrome

    • Concomitant use of known potent CYP3A4/5 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir is prohibited

    • Patients who are being actively treated for an ongoing concurrent malignancy are ineligible, with the exception of those receiving adjuvant hormone therapies and those receiving topical therapies for skin cancers

    • Patient must not have, in the opinion of the investigator, any other concurrent medical condition that would prevent the patient from complying with the study procedures

    • Patient must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent

    • Patient must not have had major surgery within 2 weeks prior to randomization and patients must have recovered from any effects of any major surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anchorage Associates in Radiation Medicine Anchorage Alaska United States 98508
    2 Anchorage Radiation Therapy Center Anchorage Alaska United States 99504
    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 Kingman Regional Medical Center Kingman Arizona United States 86401
    11 Cancer Center at Saint Joseph's Phoenix Arizona United States 85004
    12 Mercy Hospital Fort Smith Fort Smith Arkansas United States 72903
    13 CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas United States 71913
    14 Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California United States 93420
    15 PCR Oncology Arroyo Grande California United States 93420
    16 Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California United States 91505
    17 Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California United States 93401
    18 Mission Hope Medical Oncology - Santa Maria Santa Maria California United States 93444
    19 Northbay Cancer Center Vacaville California United States 95687
    20 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
    21 Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado United States 80907
    22 Porter Adventist Hospital Denver Colorado United States 80210
    23 Mercy Medical Center Durango Colorado United States 81301
    24 Southwest Oncology PC Durango Colorado United States 81301
    25 Saint Anthony Hospital Lakewood Colorado United States 80228
    26 Littleton Adventist Hospital Littleton Colorado United States 80122
    27 Longmont United Hospital Longmont Colorado United States 80501
    28 Rocky Mountain Cancer Centers-Longmont Longmont Colorado United States 80501
    29 Parker Adventist Hospital Parker Colorado United States 80138
    30 Saint Mary Corwin Medical Center Pueblo Colorado United States 81004
    31 AdventHealth Altamonte Altamonte Springs Florida United States 32701
    32 AdventHealth Celebration Celebration Florida United States 34747
    33 UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables Florida United States 33146
    34 UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida United States 33442
    35 AdventHealth Kissimmee Kissimmee Florida United States 34744
    36 University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida United States 33136
    37 UM Sylvester Comprehensive Cancer Center at Kendall Miami Florida United States 33176
    38 AdventHealth Medical Group Urology at Orlando Orlando Florida United States 32803
    39 AdventHealth Orlando Orlando Florida United States 32803
    40 AdventHealth East Orlando Orlando Florida United States 32822
    41 UM Sylvester Comprehensive Cancer Center at Plantation Plantation Florida United States 33324
    42 AdventHealth Winter Park Winter Park Florida United States 32792
    43 Emory University Hospital Midtown Atlanta Georgia United States 30308
    44 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322
    45 Emory Saint Joseph's Hospital Atlanta Georgia United States 30342
    46 Saint Luke's Cancer Institute - Boise Boise Idaho United States 83712
    47 Saint Luke's Cancer Institute - Fruitland Fruitland Idaho United States 83619
    48 Saint Luke's Cancer Institute - Meridian Meridian Idaho United States 83642
    49 Saint Luke's Cancer Institute - Nampa Nampa Idaho United States 83686
    50 Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho United States 83301
    51 Saint Anthony's Health Alton Illinois United States 62002
    52 Rush - Copley Medical Center Aurora Illinois United States 60504
    53 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
    54 Illinois CancerCare-Canton Canton Illinois United States 61520
    55 Memorial Hospital of Carbondale Carbondale Illinois United States 62902
    56 SIH Cancer Institute Carterville Illinois United States 62918
    57 Illinois CancerCare-Carthage Carthage Illinois United States 62321
    58 Centralia Oncology Clinic Centralia Illinois United States 62801
    59 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
    60 Carle on Vermilion Danville Illinois United States 61832
    61 Cancer Care Specialists of Illinois - Decatur Decatur Illinois United States 62526
    62 Decatur Memorial Hospital Decatur Illinois United States 62526
    63 Illinois CancerCare-Dixon Dixon Illinois United States 61021
    64 Carle Physician Group-Effingham Effingham Illinois United States 62401
    65 Crossroads Cancer Center Effingham Illinois United States 62401
    66 Elmhurst Memorial Hospital Elmhurst Illinois United States 60126
    67 Illinois CancerCare-Eureka Eureka Illinois United States 61530
    68 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
    69 Western Illinois Cancer Treatment Center Galesburg Illinois United States 61401
    70 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
    71 Illinois CancerCare-Macomb Macomb Illinois United States 61455
    72 Carle Physician Group-Mattoon/Charleston Mattoon Illinois United States 61938
    73 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
    74 Edward Hospital/Cancer Center Naperville Illinois United States 60540
    75 UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois United States 60451
    76 Cancer Care Center of O'Fallon O'Fallon Illinois United States 62269
    77 University of Chicago Medicine-Orland Park Orland Park Illinois United States 60462
    78 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    79 Illinois CancerCare-Pekin Pekin Illinois United States 61554
    80 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    81 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    82 Illinois CancerCare-Peru Peru Illinois United States 61354
    83 Valley Radiation Oncology Peru Illinois United States 61354
    84 Edward Hospital/Cancer Center?Plainfield Plainfield Illinois United States 60585
    85 Illinois CancerCare-Princeton Princeton Illinois United States 61356
    86 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    87 Springfield Clinic Springfield Illinois United States 62702
    88 Memorial Medical Center Springfield Illinois United States 62781
    89 Carle Cancer Center Urbana Illinois United States 61801
    90 The Carle Foundation Hospital Urbana Illinois United States 61801
    91 Illinois CancerCare - Washington Washington Illinois United States 61571
    92 Rush-Copley Healthcare Center Yorkville Illinois United States 60560
    93 Northwest Cancer Center - Main Campus Crown Point Indiana United States 46307
    94 Northwest Oncology LLC Dyer Indiana United States 46311
    95 Saint Mary Medical Center Hobart Indiana United States 46342
    96 The Community Hospital Munster Indiana United States 46321
    97 Memorial Hospital of South Bend South Bend Indiana United States 46601
    98 Mary Greeley Medical Center Ames Iowa United States 50010
    99 McFarland Clinic PC - Ames Ames Iowa United States 50010
    100 McFarland Clinic PC-Boone Boone Iowa United States 50036
    101 Saint Anthony Regional Hospital Carroll Iowa United States 51401
    102 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa United States 50325
    103 Mercy Cancer Center-West Lakes Clive Iowa United States 50325
    104 Alegent Health Mercy Hospital Council Bluffs Iowa United States 51503
    105 Greater Regional Medical Center Creston Iowa United States 50801
    106 Iowa Methodist Medical Center Des Moines Iowa United States 50309
    107 Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa United States 50309
    108 Broadlawns Medical Center Des Moines Iowa United States 50314
    109 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
    110 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    111 Iowa Lutheran Hospital Des Moines Iowa United States 50316
    112 McFarland Clinic PC-Trinity Cancer Center Fort Dodge Iowa United States 50501
    113 Trinity Regional Medical Center Fort Dodge Iowa United States 50501
    114 McFarland Clinic PC-Jefferson Jefferson Iowa United States 50129
    115 McFarland Clinic PC-Marshalltown Marshalltown Iowa United States 50158
    116 Methodist West Hospital West Des Moines Iowa United States 50266-7700
    117 Mercy Medical Center-West Lakes West Des Moines Iowa United States 50266
    118 University of Kansas Clinical Research Center Fairway Kansas United States 66205
    119 Central Care Cancer Center - Garden City Garden City Kansas United States 67846
    120 Central Care Cancer Center - Great Bend Great Bend Kansas United States 67530
    121 HaysMed University of Kansas Health System Hays Kansas United States 67601
    122 University of Kansas Cancer Center Kansas City Kansas United States 66160
    123 Lawrence Memorial Hospital Lawrence Kansas United States 66044
    124 Olathe Health Cancer Center Olathe Kansas United States 66061
    125 University of Kansas Cancer Center-Overland Park Overland Park Kansas United States 66210
    126 University of Kansas Hospital-Indian Creek Campus Overland Park Kansas United States 66211
    127 Ascension Via Christi - Pittsburg Pittsburg Kansas United States 66762
    128 Salina Regional Health Center Salina Kansas United States 67401
    129 University of Kansas Health System Saint Francis Campus Topeka Kansas United States 66606
    130 University of Kansas Hospital-Westwood Cancer Center Westwood Kansas United States 66205
    131 Flaget Memorial Hospital Bardstown Kentucky United States 40004
    132 Commonwealth Cancer Center-Corbin Corbin Kentucky United States 40701
    133 Saint Joseph Radiation Oncology Resource Center Lexington Kentucky United States 40504
    134 Saint Joseph Hospital East Lexington Kentucky United States 40509
    135 Saint Joseph London London Kentucky United States 40741
    136 Jewish Hospital Louisville Kentucky United States 40202
    137 Saints Mary and Elizabeth Hospital Louisville Kentucky United States 40215
    138 UofL Health Medical Center Northeast Louisville Kentucky United States 40245
    139 Jewish Hospital Medical Center South Shepherdsville Kentucky United States 40165
    140 Hickman Cancer Center Adrian Michigan United States 49221
    141 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    142 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
    143 Saint Joseph Mercy Brighton Brighton Michigan United States 48114
    144 Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan United States 48114
    145 Saint Joseph Mercy Canton Canton Michigan United States 48188
    146 Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan United States 48188
    147 Saint Joseph Mercy Chelsea Chelsea Michigan United States 48118
    148 Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan United States 48118
    149 Ascension Saint John Hospital Detroit Michigan United States 48236
    150 Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan United States 48054
    151 Genesee Cancer and Blood Disease Treatment Center Flint Michigan United States 48503
    152 Genesee Hematology Oncology PC Flint Michigan United States 48503
    153 Genesys Hurley Cancer Institute Flint Michigan United States 48503
    154 Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan United States 48236
    155 Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan United States 48236
    156 Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan United States 48154
    157 Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan United States 48044
    158 Toledo Clinic Cancer Centers-Monroe Monroe Michigan United States 48162
    159 Ascension Providence Hospitals - Novi Novi Michigan United States 48374
    160 Ascension Providence Hospitals - Southfield Southfield Michigan United States 48075
    161 Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan United States 48312
    162 Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan United States 48093
    163 Saint John Macomb-Oakland Hospital Warren Michigan United States 48093
    164 Huron Gastroenterology PC Ypsilanti Michigan United States 48106
    165 Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan United States 48197
    166 Sanford Joe Lueken Cancer Center Bemidji Minnesota United States 56601
    167 Saint Luke's Hospital of Duluth Duluth Minnesota United States 55805
    168 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
    169 Mayo Clinic in Rochester Rochester Minnesota United States 55905
    170 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
    171 Regions Hospital Saint Paul Minnesota United States 55101
    172 Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri United States 63011
    173 Central Care Cancer Center - Bolivar Bolivar Missouri United States 65613
    174 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    175 Southeast Cancer Center Cape Girardeau Missouri United States 63703
    176 Parkland Health Center - Farmington Farmington Missouri United States 63640
    177 Capital Region Southwest Campus Jefferson City Missouri United States 65109
    178 Freeman Health System Joplin Missouri United States 64804
    179 Mercy Hospital Joplin Joplin Missouri United States 64804
    180 Truman Medical Centers Kansas City Missouri United States 64108
    181 University of Kansas Cancer Center - North Kansas City Missouri United States 64154
    182 University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri United States 64064
    183 University of Kansas Cancer Center at North Kansas City Hospital North Kansas City Missouri United States 64116
    184 Delbert Day Cancer Institute at PCRMC Rolla Missouri United States 65401
    185 Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri United States 65401
    186 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
    187 Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri United States 63109
    188 Mercy Hospital South Saint Louis Missouri United States 63128
    189 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    190 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    191 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri United States 63670
    192 Mercy Hospital Springfield Springfield Missouri United States 65804
    193 CoxHealth South Hospital Springfield Missouri United States 65807
    194 Missouri Baptist Sullivan Hospital Sullivan Missouri United States 63080
    195 Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri United States 63127
    196 Mercy Hospital Washington Washington Missouri United States 63090
    197 Saint Patrick Hospital - Community Hospital Missoula Montana United States 59802
    198 CHI Health Saint Francis Grand Island Nebraska United States 68803
    199 CHI Health Good Samaritan Kearney Nebraska United States 68847
    200 Saint Elizabeth Regional Medical Center Lincoln Nebraska United States 68510
    201 Alegent Health Immanuel Medical Center Omaha Nebraska United States 68122
    202 Alegent Health Bergan Mercy Medical Center Omaha Nebraska United States 68124
    203 Alegent Health Lakeside Hospital Omaha Nebraska United States 68130
    204 Creighton University Medical Center Omaha Nebraska United States 68131
    205 Midlands Community Hospital Papillion Nebraska United States 68046
    206 Carson Tahoe Regional Medical Center Carson City Nevada United States 89703
    207 Cancer and Blood Specialists-Henderson Henderson Nevada United States 89052
    208 Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada United States 89052
    209 Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson Nevada United States 89052
    210 Las Vegas Cancer Center-Henderson Henderson Nevada United States 89052
    211 OptumCare Cancer Care at Seven Hills Henderson Nevada United States 89052
    212 Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson Nevada United States 89074
    213 GenesisCare USA - Henderson Henderson Nevada United States 89074
    214 Las Vegas Urology - Green Valley Henderson Nevada United States 89074
    215 Las Vegas Urology - Pebble Henderson Nevada United States 89074
    216 Urology Specialists of Nevada - Green Valley Henderson Nevada United States 89074
    217 Las Vegas Urology - Pecos Las Vegas Nevada United States 89074
    218 Desert West Surgery Las Vegas Nevada United States 89102
    219 OptumCare Cancer Care at Charleston Las Vegas Nevada United States 89102
    220 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
    221 Hope Cancer Care of Nevada Las Vegas Nevada United States 89103
    222 Radiation Oncology Centers of Nevada Central Las Vegas Nevada United States 89106
    223 Urology Specialists of Nevada - Central Las Vegas Nevada United States 89106
    224 GenesisCare USA - Las Vegas Las Vegas Nevada United States 89109
    225 Sunrise Hospital and Medical Center Las Vegas Nevada United States 89109
    226 Las Vegas Prostate Cancer Center Las Vegas Nevada United States 89113
    227 Las Vegas Urology - Sunset Las Vegas Nevada United States 89113
    228 Urology Specialists of Nevada - Southwest Las Vegas Nevada United States 89113
    229 Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada United States 89119
    230 Ann M Wierman MD LTD Las Vegas Nevada United States 89128
    231 Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada United States 89128
    232 GenesisCare USA - Vegas Tenaya Las Vegas Nevada United States 89128
    233 Las Vegas Urology - Cathedral Rock Las Vegas Nevada United States 89128
    234 Las Vegas Urology - Smoke Ranch Las Vegas Nevada United States 89128
    235 OptumCare Cancer Care at MountainView Las Vegas Nevada United States 89128
    236 Urology Specialists of Nevada - Northwest Las Vegas Nevada United States 89128
    237 Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada United States 89135
    238 Comprehensive Cancer Centers of Nevada - Town Center Las Vegas Nevada United States 89144
    239 Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada United States 89144
    240 Summerlin Hospital Medical Center Las Vegas Nevada United States 89144
    241 Las Vegas Cancer Center-Medical Center Las Vegas Nevada United States 89148-2405
    242 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89148
    243 GenesisCare USA - Fort Apache Las Vegas Nevada United States 89148
    244 OptumCare Cancer Care at Fort Apache Las Vegas Nevada United States 89148
    245 Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada United States 89169
    246 University Cancer Center Las Vegas Nevada United States 89169
    247 Hope Cancer Care of Nevada-Pahrump Pahrump Nevada United States 89048
    248 Renown Regional Medical Center Reno Nevada United States 89502
    249 Saint Mary's Regional Medical Center Reno Nevada United States 89503
    250 Radiation Oncology Associates Reno Nevada United States 89509
    251 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    252 Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey United States 07920
    253 Cooper Hospital University Medical Center Camden New Jersey United States 08103
    254 Memorial Sloan Kettering Monmouth Middletown New Jersey United States 07748
    255 Memorial Sloan Kettering Bergen Montvale New Jersey United States 07645
    256 Holy Name Hospital Teaneck New Jersey United States 07666
    257 MD Anderson Cancer Center at Cooper-Voorhees Voorhees New Jersey United States 08043
    258 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
    259 Memorial Sloan Kettering Commack Commack New York United States 11725
    260 Memorial Sloan Kettering Westchester Harrison New York United States 10604
    261 Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York United States 10016
    262 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    263 Memorial Sloan Kettering Nassau Uniondale New York United States 11553
    264 Southeastern Medical Oncology Center-Clinton Clinton North Carolina United States 28328
    265 Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina United States 27534
    266 Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina United States 28546
    267 Sanford Bismarck Medical Center Bismarck North Dakota United States 58501
    268 Sanford Broadway Medical Center Fargo North Dakota United States 58122
    269 Sanford Roger Maris Cancer Center Fargo North Dakota United States 58122
    270 Good Samaritan Hospital - Cincinnati Cincinnati Ohio United States 45220
    271 Bethesda North Hospital Cincinnati Ohio United States 45242
    272 TriHealth Cancer Institute-Westside Cincinnati Ohio United States 45247
    273 TriHealth Cancer Institute-Anderson Cincinnati Ohio United States 45255
    274 Mercy Health - Saint Anne Hospital Toledo Ohio United States 43623
    275 Toledo Clinic Cancer Centers-Toledo Toledo Ohio United States 43623
    276 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    277 Mercy Hospital Oklahoma City Oklahoma City Oklahoma United States 73120
    278 Saint Charles Health System Bend Oregon United States 97701
    279 Clackamas Radiation Oncology Center Clackamas Oregon United States 97015
    280 Providence Cancer Institute Clackamas Clinic Clackamas Oregon United States 97015
    281 Bay Area Hospital Coos Bay Oregon United States 97420
    282 Providence Newberg Medical Center Newberg Oregon United States 97132
    283 Providence Portland Medical Center Portland Oregon United States 97213
    284 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    285 Saint Charles Health System-Redmond Redmond Oregon United States 97756
    286 Bryn Mawr Hospital Bryn Mawr Pennsylvania United States 19010
    287 Main Line Health Center-Collegeville Collegeville Pennsylvania United States 19426
    288 Main Line Health Center-Exton Exton Pennsylvania United States 19341
    289 Riddle Memorial Hospital Media Pennsylvania United States 19063
    290 Paoli Memorial Hospital Paoli Pennsylvania United States 19301
    291 University of Pennsylvania/Abramson Cancer Center Philadelphia Pennsylvania United States 19104
    292 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    293 Lankenau Medical Center Wynnewood Pennsylvania United States 19096
    294 Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota United States 57104
    295 Avera Cancer Institute Sioux Falls South Dakota United States 57105
    296 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    297 Saint Joseph Regional Cancer Center Bryan Texas United States 77802
    298 Farmington Health Center Farmington Utah United States 84025
    299 University of Utah Sugarhouse Health Center Salt Lake City Utah United States 84106
    300 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
    301 Norris Cotton Cancer Center-North Saint Johnsbury Vermont United States 05819
    302 Providence Regional Cancer System-Aberdeen Aberdeen Washington United States 98520
    303 MultiCare Auburn Medical Center Auburn Washington United States 98001
    304 Overlake Medical Center Bellevue Washington United States 98004
    305 PeaceHealth Saint Joseph Medical Center Bellingham Washington United States 98225
    306 Harrison Medical Center Bremerton Washington United States 98310
    307 Highline Medical Center-Main Campus Burien Washington United States 98166
    308 Providence Regional Cancer System-Centralia Centralia Washington United States 98531
    309 Swedish Cancer Institute-Edmonds Edmonds Washington United States 98026
    310 Saint Elizabeth Hospital Enumclaw Washington United States 98022
    311 Providence Regional Cancer Partnership Everett Washington United States 98201
    312 Saint Francis Hospital Federal Way Washington United States 98003
    313 MultiCare Gig Harbor Medical Park Gig Harbor Washington United States 98335
    314 Swedish Cancer Institute-Issaquah Issaquah Washington United States 98029
    315 Kadlec Clinic Hematology and Oncology Kennewick Washington United States 99336
    316 Providence Regional Cancer System-Lacey Lacey Washington United States 98503
    317 Saint Clare Hospital Lakewood Washington United States 98499
    318 PeaceHealth Saint John Medical Center Longview Washington United States 98632
    319 MultiCare Good Samaritan Hospital Puyallup Washington United States 98372
    320 Valley Medical Center Renton Washington United States 98055
    321 Pacific Gynecology Specialists Seattle Washington United States 98104
    322 Swedish Medical Center-Ballard Campus Seattle Washington United States 98107
    323 Swedish Medical Center-First Hill Seattle Washington United States 98122-4307
    324 Swedish Medical Center-Cherry Hill Seattle Washington United States 98122-5711
    325 PeaceHealth United General Medical Center Sedro-Woolley Washington United States 98284
    326 Providence Regional Cancer System-Shelton Shelton Washington United States 98584
    327 MultiCare Deaconess Cancer and Blood Specialty Center - Valley Spokane Valley Washington United States 99216
    328 MultiCare Deaconess Cancer and Blood Specialty Center - Downtown Spokane Washington United States 99204
    329 MultiCare Deaconess Cancer and Blood Specialty Center - North Spokane Washington United States 99218
    330 Franciscan Research Center-Northwest Medical Plaza Tacoma Washington United States 98405
    331 MultiCare Tacoma General Hospital Tacoma Washington United States 98405
    332 PeaceHealth Southwest Medical Center Vancouver Washington United States 98664
    333 Providence Saint Mary Regional Cancer Center Walla Walla Washington United States 99362
    334 North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington United States 98902
    335 Providence Regional Cancer System-Yelm Yelm Washington United States 98597
    336 ThedaCare Regional Cancer Center Appleton Wisconsin United States 54911
    337 UW Cancer Center Johnson Creek Johnson Creek Wisconsin United States 53038
    338 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
    339 University of Wisconsin Carbone Cancer Center Madison Wisconsin United States 53792
    340 ProHealth D N Greenwald Center Mukwonago Wisconsin United States 53149
    341 ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin United States 53066
    342 ProHealth Waukesha Memorial Hospital Waukesha Wisconsin United States 53188
    343 UW Cancer Center at ProHealth Care Waukesha Wisconsin United States 53188

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Kim A Reiss Binder, ECOG-ACRIN Cancer Research Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT04858334
    Other Study ID Numbers:
    • NCI-2020-05659
    • NCI-2020-05659
    • EA2192
    • EA2192
    • U10CA180820
    First Posted:
    Apr 26, 2021
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 25, 2022