Pancreas Cancer

EA2192 / APOLLO



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

STATUS: Active


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.
  • 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 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 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)

  • 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

  • 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 =< 1.5 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 x 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 =< 1.5 institutional ULN OR calculated Cockcroft Gault creatinine clearance > 50 mL/min/1.73 m^2 (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 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 have the ability to understand and the willingness to sign a written informed consent document, or have legally authorized representative provide authorization to participate

  • Patient must not have had major surgery within 2 weeks prior to Step 1 randomization and patients must have recovered from any effects of any major surgery

Israel
Haifa
Rambam Medical Center
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United States
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Anchorage
Alaska Breast Care and Surgery LLC
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Providence Alaska Medical Center
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Fairbanks
Fairbanks Memorial Hospital
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AR
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Mercy Hospital Fort Smith
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Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
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Jonesboro
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
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AZ
Kingman
Kingman Regional Medical Center
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Cancer Center at Saint Joseph's
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CA
Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
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PCR Oncology
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Berkeley
Alta Bates Summit Medical Center-Herrick Campus
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Burbank
Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Memorial Medical Center
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Saint Joseph Hospital - Orange
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California Pacific Medical Center-Pacific Campus
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Pacific Central Coast Health Center-San Luis Obispo
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Santa Maria
Mission Hope Medical Oncology - Santa Maria
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Sutter Pacific Medical Foundation
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Northbay Cancer Center
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Colorado Springs
Penrose-Saint Francis Healthcare
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Porter Adventist Hospital
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Mercy Medical Center
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Saint Anthony Hospital
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Littleton Adventist Hospital
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Longmont United Hospital
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Parker Adventist Hospital
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Saint Mary Corwin Medical Center
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DC
Washington
Sibley Memorial Hospital
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FL
Altamonte Springs
AdventHealth Altamonte
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Celebration
AdventHealth Celebration
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Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
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Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
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Kissimmee
AdventHealth Kissimmee
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Miami
UM Sylvester Comprehensive Cancer Center at Kendall
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University of Miami Miller School of Medicine-Sylvester Cancer Center
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Orlando
AdventHealth East Orlando
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AdventHealth Medical Group Urology at Orlando
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AdventHealth Orlando
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Plantation
UM Sylvester Comprehensive Cancer Center at Plantation
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Winter Park
AdventHealth Winter Park
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GA
Atlanta
Emory Saint Joseph's Hospital
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Emory University Hospital Midtown
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Emory University Hospital/Winship Cancer Institute
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IA
Ames
Mary Greeley Medical Center
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McFarland Clinic - Ames
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Ankeny
Mission Cancer and Blood - Ankeny
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Boone
McFarland Clinic - Boone
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Carroll
Saint Anthony Regional Hospital
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Clive
Mercy Cancer Center-West Lakes
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Mission Cancer and Blood - West Des Moines
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Council Bluffs
Alegent Health Mercy Hospital
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Creston
Greater Regional Medical Center
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Des Moines
Broadlawns Medical Center
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Iowa Lutheran Hospital
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Iowa Methodist Medical Center
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Mercy Medical Center - Des Moines
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Mission Cancer and Blood - Des Moines
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Mission Cancer and Blood - Laurel
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Fort Dodge
McFarland Clinic - Trinity Cancer Center
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Trinity Regional Medical Center
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Jefferson
McFarland Clinic - Jefferson
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Marshalltown
McFarland Clinic - Marshalltown
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West Des Moines
Mercy Medical Center-West Lakes
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Email: cancerresearch@mercydesmoines.org

Methodist West Hospital
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ID
Boise
Saint Luke's Cancer Institute - Boise
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Email: eslinget@slhs.org

Fruitland
Saint Luke's Cancer Institute - Fruitland
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Email: eslinget@slhs.org

Meridian
Saint Luke's Cancer Institute - Meridian
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Email: eslinget@slhs.org

Nampa
Saint Luke's Cancer Institute - Nampa
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Email: eslinget@slhs.org

Twin Falls
Saint Luke's Cancer Institute - Twin Falls
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Email: eslinget@slhs.org

IL
Alton
Saint Anthony's Health
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Aurora
Rush - Copley Medical Center
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Email: Cancer.Research@rushcopley.com

Bloomington
Illinois CancerCare-Bloomington
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Email: andersonj@illinoiscancercare.com

Canton
Illinois CancerCare-Canton
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Email: andersonj@illinoiscancercare.com

Carbondale
Memorial Hospital of Carbondale
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Email: clinical.research@sih.net

Carterville
SIH Cancer Institute
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Email: clinical.research@sih.net

Carthage
Illinois CancerCare-Carthage
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Email: andersonj@illinoiscancercare.com

Centralia
Centralia Oncology Clinic
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Email: morganthaler.jodi@mhsil.com

Chicago
University of Chicago Comprehensive Cancer Center
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Email: cancerclinicaltrials@bsd.uchicago.edu

University of Illinois
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Danville
Carle at The Riverfront
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Email: Research@Carle.com

Decatur
Cancer Care Specialists of Illinois - Decatur
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Email: morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
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Dixon
Illinois CancerCare-Dixon
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Effingham
Carle Physician Group-Effingham
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Crossroads Cancer Center
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Elmhurst
Elmhurst Memorial Hospital
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Email: Jrohde@emhc.org

Eureka
Illinois CancerCare-Eureka
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Galesburg
Illinois CancerCare-Galesburg
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Western Illinois Cancer Treatment Center
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Kewanee
Illinois CancerCare-Kewanee Clinic
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Macomb
Illinois CancerCare-Macomb
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Email: andersonj@illinoiscancercare.com

Mattoon
Carle Physician Group-Mattoon/Charleston
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Mount Vernon
Good Samaritan Regional Health Center
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Naperville
Edward Hospital/Cancer Center
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New Lenox
UC Comprehensive Cancer Center at Silver Cross
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O'Fallon
Cancer Care Center of O'Fallon
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Orland Park
University of Chicago Medicine-Orland Park
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Ottawa
Illinois CancerCare-Ottawa Clinic
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Pekin
Illinois CancerCare-Pekin
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Peoria
Illinois CancerCare-Peoria
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Methodist Medical Center of Illinois
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Peru
Illinois CancerCare-Peru
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Valley Radiation Oncology
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Plainfield
Edward Hospital/Cancer Center?Plainfield
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Princeton
Illinois CancerCare-Princeton
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Springfield
Memorial Medical Center
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Southern Illinois University School of Medicine
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Urbana
Carle Cancer Center
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Washington
Illinois CancerCare - Washington
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Yorkville
Rush-Copley Healthcare Center
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IN
Carmel
IU Health North Hospital
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Crown Point
Northwest Cancer Center - Main Campus
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Dyer
Northwest Oncology LLC
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Hobart
Saint Mary Medical Center
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Indianapolis
Indiana University/Melvin and Bren Simon Cancer Center
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Munster
The Community Hospital
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South Bend
Memorial Hospital of South Bend
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KS
Fairway
University of Kansas Clinical Research Center
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Garden City
Central Care Cancer Center - Garden City
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Great Bend
Central Care Cancer Center - Great Bend
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Hays
HaysMed
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Kansas City
University of Kansas Cancer Center
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Lawrence
Lawrence Memorial Hospital
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Olathe Health Cancer Center
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University of Kansas Cancer Center-Overland Park
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Pittsburg
Ascension Via Christi - Pittsburg
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Freeman Physician Group of Pittsburg
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Salina
Salina Regional Health Center
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Topeka
University of Kansas Health System Saint Francis Campus
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Westwood
University of Kansas Hospital-Westwood Cancer Center
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KY
Bardstown
Flaget Memorial Hospital
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Corbin
Commonwealth Cancer Center-Corbin
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Lexington
Saint Joseph Hospital East
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Saint Joseph Radiation Oncology Resource Center
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London
Saint Joseph London
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Louisville
Jewish Hospital
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Saints Mary and Elizabeth Hospital
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UofL Health Medical Center Northeast
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Shepherdsville
Jewish Hospital Medical Center South
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LA
Baton Rouge
Louisiana Hematology Oncology Associates LLC
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Mary Bird Perkins Cancer Center
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Covington
Ochsner Hematology Oncology North Shore - Covington (West Region)
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New Orleans
Ochsner Medical Center Jefferson
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MI
Adrian
Hickman Cancer Center
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Ann Arbor
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Email: MCRCwebsitecontactform@stjoeshealth.org

University of Michigan Comprehensive Cancer Center
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Brighton
Trinity Health IHA Medical Group Hematology Oncology - Brighton
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Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Medical Center - Brighton
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Email: MCRCwebsitecontactform@stjoeshealth.org

Canton
Trinity Health IHA Medical Group Hematology Oncology - Canton
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Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Medical Center - Canton
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Chelsea
Chelsea Hospital
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Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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Email: MCRCwebsitecontactform@stjoeshealth.org

Clarkston
Hematology Oncology Consultants-Clarkston
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Email: MCRCwebsitecontactform@stjoeshealth.org

Newland Medical Associates-Clarkston
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Email: MCRCwebsitecontactform@stjoeshealth.org

Detroit
Ascension Saint John Hospital
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Email: karen.forman@ascension.org

East China
Great Lakes Cancer Management Specialists-Doctors Park
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Email: karen.forman@ascension.org

Farmington Hills
Corewell Health Farmington Hills Hospital
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Flint
Genesee Cancer and Blood Disease Treatment Center
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Email: wstrong@ghci.org

Genesee Hematology Oncology PC
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Email: wstrong@ghci.org

Genesys Hurley Cancer Institute
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Email: wstrong@ghci.org

Grosse Pointe Woods
Academic Hematology Oncology Specialists
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Email: karen.forman@ascension.org

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
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Email: karen.forman@ascension.org

Livonia
Trinity Health Saint Mary Mercy Livonia Hospital
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Email: MCRCwebsitecontactform@stjoeshealth.org

Macomb Township
Great Lakes Cancer Management Specialists-Macomb Medical Campus
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Email: karen.forman@ascension.org

Monroe
Toledo Clinic Cancer Centers-Monroe
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Novi
Henry Ford Health Providence Novi Hospital
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Email: kfife3@hfhs.org

Pontiac
Michigan Healthcare Professionals Pontiac
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Email: Emily.Crofts@trinity-health.org

Newland Medical Associates-Pontiac
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Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Saint Joseph Mercy Oakland Hospital
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Royal Oak
Corewell Health William Beaumont University Hospital
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Saginaw
MyMichigan Medical Center Saginaw
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Email: MCRCwebsitecontactform@stjoeshealth.org

Oncology Hematology Associates of Saginaw Valley PC
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Southfield
Henry Ford Health Providence Southfield Hospital
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Email: kfife3@hfhs.org

Sterling Heights
Bhadresh Nayak MD PC-Sterling Heights
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Email: karen.forman@ascension.org

Tawas City
MyMichigan Medical Center Tawas
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Email: MCRCwebsitecontactform@stjoeshealth.org

Troy
Corewell Health Beaumont Troy Hospital
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Warren
Great Lakes Cancer Management Specialists-Macomb Professional Building
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Email: karen.forman@ascension.org

Saint John Macomb-Oakland Hospital
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Email: karen.forman@ascension.org

West Branch
Saint Mary's Oncology/Hematology Associates of West Branch
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Email: lori.srebinski@ascension.org

Ypsilanti
Huron Gastroenterology PC
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Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
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Email: MCRCwebsitecontactform@stjoeshealth.org

MN
Bemidji
Sanford Joe Lueken Cancer Center
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Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Duluth
Saint Luke's Hospital of Duluth
Contact: Site Public Contact
Email: kdean@slhduluth.com

Minneapolis
Abbott-Northwestern Hospital
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Email: mmcorc@healthpartners.com

Rochester
Mayo Clinic in Rochester
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Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
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Email: mmcorc@healthpartners.com

Saint Paul
Regions Hospital
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Email: mmcorc@healthpartners.com

MO
Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Contact: Site Public Contact

Bolivar
Central Care Cancer Center - Bolivar
Contact: Site Public Contact
Email: aroland@kccop.org

Cape Girardeau
Saint Francis Medical Center
Contact: Site Public Contact
Email: sfmc@sfmc.net

Southeast Cancer Center
Contact: Site Public Contact

Farmington
Parkland Health Center - Farmington
Contact: Site Public Contact

Jefferson City
MU Health Care Goldschmidt Cancer Center
Contact: Site Public Contact
Email: amy.franken@health.missouri.edu

Joplin
Freeman Health System
Contact: Site Public Contact
Email: LJCrockett@freemanhealth.com

Mercy Hospital Joplin
Contact: Site Public Contact
Email: esmeralda.carrillo@mercy.net

Kansas City
Saint Luke's Hospital of Kansas City
Contact: Site Public Contact
Email: aroland@kccop.org

University Health Truman Medical Center
Contact: Site Public Contact

University of Kansas Cancer Center - North
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

Lee's Summit
Saint Luke's East - Lee's Summit
Contact: Site Public Contact
Email: aroland@kccop.org

University of Kansas Cancer Center - Lee's Summit
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

North Kansas City
University of Kansas Cancer Center at North Kansas City Hospital
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

Rolla
Delbert Day Cancer Institute at PCRMC
Contact: Site Public Contact
Email: research@phelpshealth.org

Mercy Clinic-Rolla-Cancer and Hematology
Contact: Site Public Contact

Saint Joseph
Heartland Regional Medical Center
Contact: Site Public Contact
Email: linda.schumacher@mymlc.com

Saint Louis
Mercy Hospital Saint Louis
Contact: Site Public Contact

Mercy Hospital South
Contact: Site Public Contact
Email: Danielle.Werle@mercy.net

Missouri Baptist Medical Center
Contact: Site Public Contact

Saint Louis Cancer and Breast Institute-South City
Contact: Site Public Contact

Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Contact: Site Public Contact

Springfield
CoxHealth South Hospital
Contact: Site Public Contact

Mercy Hospital Springfield
Contact: Site Public Contact

Sullivan
Missouri Baptist Sullivan Hospital
Contact: Site Public Contact

Sunset Hills
BJC Outpatient Center at Sunset Hills
Contact: Site Public Contact

Washington
Mercy Hospital Washington
Contact: Site Public Contact

MS
Columbus
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org

Grenada
Baptist Cancer Center-Grenada
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org

New Albany
Baptist Memorial Hospital and Cancer Center-Union County
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org

Oxford
Baptist Memorial Hospital and Cancer Center-Oxford
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org

Southhaven
Baptist Memorial Hospital and Cancer Center-Desoto
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org

MT
Missoula
Saint Patrick Hospital - Community Hospital
Contact: Site Public Contact
Email: amy.hanneman@providence.org

NC
Clinton
Southeastern Medical Oncology Center-Clinton
Contact: Site Public Contact
Email: jfields@cancersmoc.com

Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Contact: Site Public Contact
Email: jfields@cancersmoc.com

Jacksonville
Southeastern Medical Oncology Center-Jacksonville
Contact: Site Public Contact
Email: jfields@cancersmoc.com

ND
Bismarck
Sanford Bismarck Medical Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Fargo
Sanford Broadway Medical Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Roger Maris Cancer Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

NE
Grand Island
Nebraska Cancer Specialists/Oncology Hematology West PC
Contact: Site Public Contact

Kearney
CHI Health Good Samaritan
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Lincoln
Saint Elizabeth Regional Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Omaha
Alegent Health Bergan Mercy Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Immanuel Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Lakeside Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Creighton University Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Papillion
Midlands Community Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

NH
Lebanon
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Contact: Site Public Contact
Email: cancer.research.nurse@dartmouth.edu

NJ
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Contact: Site Public Contact

Camden
Cooper Hospital University Medical Center
Contact: Site Public Contact

Middletown
Memorial Sloan Kettering Monmouth
Contact: Site Public Contact

Montvale
Memorial Sloan Kettering Bergen
Contact: Site Public Contact

Teaneck
Holy Name Hospital
Contact: Site Public Contact

Voorhees
MD Anderson Cancer Center at Cooper-Voorhees
Contact: Site Public Contact

NM
Albuquerque
University of New Mexico Cancer Center
Contact: Site Public Contact
Email: HSC-ClinicalTrialInfo@salud.unm.edu

NV
Carson City
Carson Tahoe Regional Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

Henderson
Cancer and Blood Specialists-Henderson
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Henderson
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada-Horizon Ridge
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada-Southeast Henderson
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Henderson
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Cancer Center-Henderson
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Green Valley
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Pebble
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Seven Hills
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Green Valley
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Contact: Site Public Contact
Email: research@sncrf.org

Ann M Wierman MD LTD
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Central Valley
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Northwest
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Town Center
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada-Summerlin
Contact: Site Public Contact
Email: research@sncrf.org

Desert West Surgery
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Fort Apache
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Las Vegas
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Vegas Tenaya
Contact: Site Public Contact
Email: research@sncrf.org

Hope Cancer Care of Nevada
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Cancer Center-Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Prostate Cancer Center
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Cathedral Rock
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Pecos
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Smoke Ranch
Contact: Site Public Contact
Email: research@smcrf.org

Las Vegas Urology - Sunset
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Charleston
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Fort Apache
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at MountainView
Contact: Site Public Contact
Email: research@sncrf.org

Radiation Oncology Centers of Nevada Central
Contact: Site Public Contact
Email: research@sncrf.org

Radiation Oncology Centers of Nevada Southeast
Contact: Site Public Contact
Email: research@sncrf.org

Summerlin Hospital Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

Sunrise Hospital and Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

University Cancer Center
Contact: Site Public Contact
Email: research@sncrf.org

University Medical Center of Southern Nevada
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Central
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Northwest
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Southwest
Contact: Site Public Contact
Email: research@sncrf.org

Pahrump
Hope Cancer Care of Nevada-Pahrump
Contact: Site Public Contact
Email: research@sncrf.org

Reno
Radiation Oncology Associates
Contact: Site Public Contact
Email: research@sncrf.org

Renown Regional Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

Saint Mary's Regional Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

NY
Buffalo
Roswell Park Cancer Institute
Contact: Site Public Contact
Email: askroswell@roswellpark.org

Commack
Memorial Sloan Kettering Commack
Contact: Site Public Contact

Greenlawn
Northwell Health Cancer Institute at Huntington
Contact: Site Public Contact

Lake Success
Northwell Health/Center for Advanced Medicine
Contact: Site Public Contact

Mineola
NYU Langone Hospital - Long Island
Contact: Site Public Contact
Email: cancertrials@nyulangone.org

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Contact: Site Public Contact
Email: CancerTrials@nyulangone.org

Memorial Sloan Kettering Cancer Center
Contact: Site Public Contact

Rochester
Rochester General Hospital
Contact: Site Public Contact
Email: tia.derosa@rochestergeneral.org

Unity Park Ridge Campus
Contact: Site Public Contact
Email: ctsucontact@westat.com

Uniondale
Memorial Sloan Kettering Nassau
Contact: Site Public Contact

West Harrison
Memorial Sloan Kettering Westchester
Contact: Site Public Contact

OH
Centerville
Miami Valley Hospital South
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Cincinnati
Bethesda North Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Good Samaritan Hospital - Cincinnati
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

TriHealth Cancer Institute-Anderson
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

TriHealth Cancer Institute-Westside
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Dayton
Dayton Physician LLC - Englewood
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital North
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Premier Blood and Cancer Center
Contact: Site Public Contact

Franklin
Atrium Medical Center-Middletown Regional Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Greenville
Miami Valley Cancer Care and Infusion
Contact: Site Public Contact

Kettering
Kettering Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Toledo
Mercy Health - Saint Anne Hospital
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

Toledo Clinic Cancer Centers-Toledo
Contact: Site Public Contact

Troy
Upper Valley Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

OK
Oklahoma City
Mercy Hospital Oklahoma City
Contact: Site Public Contact

University of Oklahoma Health Sciences Center
Contact: Site Public Contact
Email: ou-clinical-trials@ouhsc.edu

OR
Bend
Saint Charles Health System
Contact: Site Public Contact
Email: nosall@stcharleshealthcare.org

Clackamas
Clackamas Radiation Oncology Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Cancer Institute Clackamas Clinic
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Coos Bay
Bay Area Hospital
Contact: Site Public Contact
Email: cherie.cox@bayareahospital.org

Newberg
Providence Newberg Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Oregon City
Providence Willamette Falls Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Portland
Oregon Health and Science University
Contact: Site Public Contact
Email: trials@ohsu.edu

Providence Portland Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Redmond
Saint Charles Health System-Redmond
Contact: Site Public Contact

PA
Bryn Mawr
Bryn Mawr Hospital
Contact: Site Public Contact
Email: turzoe@mlhs.org

Collegeville
Main Line Health Center-Collegeville
Contact: Site Public Contact
Email: turzoe@mlhs.org

Exton
Main Line Health Center-Exton
Contact: Site Public Contact
Email: turzoe@mlhs.org

Media
Riddle Memorial Hospital
Contact: Site Public Contact
Email: turzoe@mlhs.org

Paoli
Paoli Memorial Hospital
Contact: Site Public Contact
Email: turzoe@mlhs.org

Philadelphia
Fox Chase Cancer Center
Contact: Site Public Contact

University of Pennsylvania/Abramson Cancer Center
Contact: Site Public Contact
Email: PennCancerTrials@careboxhealth.com

Wynnewood
Lankenau Medical Center
Contact: Site Public Contact
Email: turzoe@mlhs.org

SD
Aberdeen
Avera Cancer Institute-Aberdeen
Contact: Site Public Contact
Email: oncregulatory@avera.org

Sioux Falls
Avera Cancer Institute
Contact: Site Public Contact
Email: OncRegulatory@avera.org

Sanford Cancer Center Oncology Clinic
Contact: Site Public Contact
Email: OncologyClinicTrialsSF@sanfordhealth.org

Sanford USD Medical Center - Sioux Falls
Contact: Site Public Contact
Email: OncologyClinicalTrialsSF@SanfordHealth.org

TN
Collierville
Baptist Memorial Hospital and Cancer Center-Collierville
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org

Memphis
Baptist Memorial Hospital and Cancer Center-Memphis
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org

TX
Bryan
Saint Joseph Regional Cancer Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Dallas
Parkland Memorial Hospital
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu

UT Southwestern Simmons Cancer Center - RedBird
Contact: Site Public Contact
Email: canceranswerline@utsouthwestern.edu

UT Southwestern/Simmons Cancer Center-Dallas
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu

Fort Worth
UT Southwestern/Simmons Cancer Center-Fort Worth
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu

Richardson
UT Southwestern Clinical Center at Richardson/Plano
Contact: Site Public Contact
Email: Suzanne.cole@utsouthwestern.edu

UT
Farmington
Farmington Health Center
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu

Salt Lake City
Huntsman Cancer Institute/University of Utah
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu

University of Utah Sugarhouse Health Center
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu

VT
Saint Johnsbury
Dartmouth Cancer Center - North
Contact: Site Public Contact
Email: cancer.research.nurse@hitchcock.org

WI
Appleton
ThedaCare Regional Cancer Center
Contact: Site Public Contact
Email: ResearchDept@thedacare.org

Eau Claire
Marshfield Medical Center-EC Cancer Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Saint Vincent Hospital Cancer Center at Saint Mary's
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Johnson Creek
University of Wisconsin Carbone Cancer Center - Johnson Creek
Contact: Site Public Contact
Email: clinicaltrials@cancer.wisc.edu

La Crosse
Gundersen Lutheran Medical Center
Contact: Site Public Contact
Email: cancerctr@gundersenhealth.org

Madison
University of Wisconsin Carbone Cancer Center - University Hospital
Contact: Site Public Contact
Email: clinicaltrials@cancer.wisc.edu

Marshfield
Marshfield Medical Center-Marshfield
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Minocqua
Marshfield Clinic-Minocqua Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Mukwonago
ProHealth D N Greenwald Center
Contact: Site Public Contact
Email: research.institute@phci.org

Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Contact: Site Public Contact

Oconto Falls
Saint Vincent Hospital Cancer Center at Oconto Falls
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Rice Lake
Marshfield Medical Center-Rice Lake
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Sheboygan
Saint Vincent Hospital Cancer Center at Sheboygan
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Sturgeon Bay
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Waukesha
ProHealth Waukesha Memorial Hospital
Contact: Site Public Contact

UW Cancer Center at ProHealth Care
Contact: Site Public Contact
Email: Chanda.miller@phci.org

Weston
Marshfield Medical Center - Weston
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

WV
Morgantown
West Virginia University Healthcare
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu

PRIMARY OBJECTIVE:
I. 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:
I. 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.
II. To evaluate overall survival (OS) in patients treated with olaparib after adjuvant chemotherapy compared to those treated with adjuvant treatment alone.
III. 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.
IV. To analyze survival differences between patients who received neoadjuvant or perioperative chemotherapy compared to those who received adjuvant therapy alone.
V. 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.
VI. To analyze RFS and OS differences in those who received any platinum-based perioperative chemotherapy compared to no-platinum based perioperative chemotherapy.

EXPLORATORY OBJECTIVES:
I. 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.
II. To analyze RFS and OS differences with those who had resectable disease at diagnosis compared to those who did not.
III. 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 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) scans or CT/magnetic resonance imaging (MRI) and collection of blood throughout the study.

ARM II: Patients receive placebo PO BID on days 1-28 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans or CT/MRI and collection of blood throughout the study.

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 after randomization.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.


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