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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04858334
Other study ID # NCI-2020-05659
Secondary ID NCI-2020-05659EA
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 22, 2021
Est. completion date October 31, 2027

Study information

Verified date November 2023
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 152
Est. completion date October 31, 2027
Est. primary completion date October 31, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Biospecimen Collection
Undergo collection of blood
Computed Tomography
Undergo CT or CT/MRI
Magnetic Resonance Imaging
Undergo CT/MRI
Drug:
Olaparib
Given PO
Placebo Administration
Given PO

Locations

Country Name City State
United States Avera Cancer Institute-Aberdeen Aberdeen South Dakota
United States Providence Regional Cancer System-Aberdeen Aberdeen Washington
United States Hickman Cancer Center Adrian Michigan
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States AdventHealth Altamonte Altamonte Springs Florida
United States Saint Anthony's Health Alton Illinois
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic - Ames Ames Iowa
United States Alaska Breast Care and Surgery LLC Anchorage Alaska
United States Alaska Oncology and Hematology LLC Anchorage Alaska
United States Alaska Women's Cancer Care Anchorage Alaska
United States Anchorage Associates in Radiation Medicine Anchorage Alaska
United States Anchorage Oncology Centre Anchorage Alaska
United States Anchorage Radiation Therapy Center Anchorage Alaska
United States Katmai Oncology Group Anchorage Alaska
United States Providence Alaska Medical Center Anchorage Alaska
United States Mission Cancer and Blood - Ankeny Ankeny Iowa
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States ThedaCare Regional Cancer Center Appleton Wisconsin
United States Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California
United States PCR Oncology Arroyo Grande California
United States Emory Saint Joseph's Hospital Atlanta Georgia
United States Emory University Hospital Midtown Atlanta Georgia
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States MultiCare Auburn Medical Center Auburn Washington
United States Rush - Copley Medical Center Aurora Illinois
United States Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri
United States Flaget Memorial Hospital Bardstown Kentucky
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Louisiana Hematology Oncology Associates LLC Baton Rouge Louisiana
United States Mary Bird Perkins Cancer Center Baton Rouge Louisiana
United States Overlake Medical Center Bellevue Washington
United States PeaceHealth Saint Joseph Medical Center Bellingham Washington
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Saint Charles Health System Bend Oregon
United States Alta Bates Summit Medical Center-Herrick Campus Berkeley California
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Luke's Cancer Institute - Boise Boise Idaho
United States Central Care Cancer Center - Bolivar Bolivar Missouri
United States McFarland Clinic - Boone Boone Iowa
United States Harrison Medical Center Bremerton Washington
United States Saint Joseph Mercy Brighton Brighton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan
United States Saint Joseph Regional Cancer Center Bryan Texas
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Roswell Park Cancer Institute Buffalo New York
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Highline Medical Center-Main Campus Burien Washington
United States Cooper Hospital University Medical Center Camden New Jersey
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Joseph Mercy Canton Canton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States Saint Anthony Regional Hospital Carroll Iowa
United States Carson Tahoe Regional Medical Center Carson City Nevada
United States SIH Cancer Institute Carterville Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States AdventHealth Celebration Celebration Florida
United States Miami Valley Hospital South Centerville Ohio
United States Centralia Oncology Clinic Centralia Illinois
United States Providence Regional Cancer System-Centralia Centralia Washington
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States University of Illinois Chicago Illinois
United States Bethesda North Hospital Cincinnati Ohio
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States TriHealth Cancer Institute-Anderson Cincinnati Ohio
United States TriHealth Cancer Institute-Westside Cincinnati Ohio
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States Providence Cancer Institute Clackamas Clinic Clackamas Oregon
United States Southeastern Medical Oncology Center-Clinton Clinton North Carolina
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Main Line Health Center-Collegeville Collegeville Pennsylvania
United States Baptist Memorial Hospital and Cancer Center-Collierville Collierville Tennessee
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado
United States Memorial Sloan Kettering Commack Commack New York
United States Bay Area Hospital Coos Bay Oregon
United States UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables Florida
United States Commonwealth Cancer Center-Corbin Corbin Kentucky
United States Alegent Health Mercy Hospital Council Bluffs Iowa
United States Ochsner Hematology Oncology North Shore - Covington (West Region) Covington Louisiana
United States Greater Regional Medical Center Creston Iowa
United States Northwest Cancer Center - Main Campus Crown Point Indiana
United States Parkland Memorial Hospital Dallas Texas
United States UT Southwestern Simmons Cancer Center - RedBird Dallas Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Carle at The Riverfront Danville Illinois
United States Dayton Blood and Cancer Center Dayton Ohio
United States Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida
United States Porter Adventist Hospital Denver Colorado
United States Broadlawns Medical Center Des Moines Iowa
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Laurel Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Illinois CancerCare-Dixon Dixon Illinois
United States Saint Luke's Hospital of Duluth Duluth Minnesota
United States Mercy Medical Center Durango Colorado
United States Southwest Oncology PC Durango Colorado
United States Northwest Oncology LLC Dyer Indiana
United States Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Swedish Cancer Institute-Edmonds Edmonds Washington
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Elmhurst Memorial Hospital Elmhurst Illinois
United States Saint Elizabeth Hospital Enumclaw Washington
United States Illinois CancerCare-Eureka Eureka Illinois
United States Providence Regional Cancer Partnership Everett Washington
United States Main Line Health Center-Exton Exton Pennsylvania
United States Fairbanks Memorial Hospital Fairbanks Alaska
United States University of Kansas Clinical Research Center Fairway Kansas
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Farmington Health Center Farmington Utah
United States Parkland Health Center - Farmington Farmington Missouri
United States Beaumont Hospital - Farmington Hills Farmington Hills Michigan
United States Saint Francis Hospital Federal Way Washington
United States Genesee Cancer and Blood Disease Treatment Center Flint Michigan
United States Genesee Hematology Oncology PC Flint Michigan
United States Genesys Hurley Cancer Institute Flint Michigan
United States McFarland Clinic - Trinity Cancer Center Fort Dodge Iowa
United States Trinity Regional Medical Center Fort Dodge Iowa
United States Mercy Hospital Fort Smith Fort Smith Arkansas
United States UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth Texas
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Saint Luke's Cancer Institute - Fruitland Fruitland Idaho
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Central Care Cancer Center - Garden City Garden City Kansas
United States MultiCare Gig Harbor Medical Park Gig Harbor Washington
United States Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina
United States CHI Health Saint Francis Grand Island Nebraska
United States Central Care Cancer Center - Great Bend Great Bend Kansas
United States Northwell Health Cancer Institute at Huntington Greenlawn New York
United States Miami Valley Cancer Care and Infusion Greenville Ohio
United States Baptist Cancer Center-Grenada Grenada Mississippi
United States Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan
United States Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan
United States Memorial Sloan Kettering Westchester Harrison New York
United States HaysMed University of Kansas Health System Hays Kansas
United States Cancer and Blood Specialists-Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson Nevada
United States GenesisCare USA - Henderson Henderson Nevada
United States Las Vegas Cancer Center-Henderson Henderson Nevada
United States Las Vegas Urology - Green Valley Henderson Nevada
United States Las Vegas Urology - Pebble Henderson Nevada
United States OptumCare Cancer Care at Seven Hills Henderson Nevada
United States Urology Specialists of Nevada - Green Valley Henderson Nevada
United States Saint Mary Medical Center Hobart Indiana
United States CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas
United States Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States Swedish Cancer Institute-Issaquah Issaquah Washington
United States Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina
United States McFarland Clinic - Jefferson Jefferson Iowa
United States Capital Region Southwest Campus Jefferson City Missouri
United States UW Cancer Center Johnson Creek Johnson Creek Wisconsin
United States NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas
United States Freeman Health System Joplin Missouri
United States Mercy Hospital Joplin Joplin Missouri
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States Truman Medical Centers Kansas City Missouri
United States University of Kansas Cancer Center Kansas City Kansas
United States University of Kansas Cancer Center - North Kansas City Missouri
United States CHI Health Good Samaritan Kearney Nebraska
United States Kadlec Clinic Hematology and Oncology Kennewick Washington
United States Kettering Medical Center Kettering Ohio
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Kingman Regional Medical Center Kingman Arizona
United States AdventHealth Kissimmee Kissimmee Florida
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States Providence Regional Cancer System-Lacey Lacey Washington
United States Northwell Health/Center for Advanced Medicine Lake Success New York
United States Saint Anthony Hospital Lakewood Colorado
United States Saint Clare Hospital Lakewood Washington
United States Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada
United States Ann M Wierman MD LTD Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Town Center Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada
United States Desert West Surgery Las Vegas Nevada
United States GenesisCare USA - Fort Apache Las Vegas Nevada
United States GenesisCare USA - Las Vegas Las Vegas Nevada
United States GenesisCare USA - Vegas Tenaya Las Vegas Nevada
United States Hope Cancer Care of Nevada Las Vegas Nevada
United States Las Vegas Cancer Center-Medical Center Las Vegas Nevada
United States Las Vegas Prostate Cancer Center Las Vegas Nevada
United States Las Vegas Urology - Cathedral Rock Las Vegas Nevada
United States Las Vegas Urology - Pecos Las Vegas Nevada
United States Las Vegas Urology - Smoke Ranch Las Vegas Nevada
United States Las Vegas Urology - Sunset Las Vegas Nevada
United States OptumCare Cancer Care at Charleston Las Vegas Nevada
United States OptumCare Cancer Care at Fort Apache Las Vegas Nevada
United States OptumCare Cancer Care at MountainView Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Central Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada
United States Summerlin Hospital Medical Center Las Vegas Nevada
United States Sunrise Hospital and Medical Center Las Vegas Nevada
United States University Cancer Center Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Urology Specialists of Nevada - Central Las Vegas Nevada
United States Urology Specialists of Nevada - Northwest Las Vegas Nevada
United States Urology Specialists of Nevada - Southwest Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon New Hampshire
United States Saint Luke's East - Lee's Summit Lee's Summit Missouri
United States University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri
United States Saint Joseph Hospital East Lexington Kentucky
United States Saint Joseph Radiation Oncology Resource Center Lexington Kentucky
United States Saint Elizabeth Regional Medical Center Lincoln Nebraska
United States Littleton Adventist Hospital Littleton Colorado
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Saint Joseph London London Kentucky
United States Longmont United Hospital Longmont Colorado
United States Rocky Mountain Cancer Centers-Longmont Longmont Colorado
United States PeaceHealth Saint John Medical Center Longview Washington
United States Jewish Hospital Louisville Kentucky
United States Saints Mary and Elizabeth Hospital Louisville Kentucky
United States UofL Health Medical Center Northeast Louisville Kentucky
United States Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan
United States Illinois CancerCare-Macomb Macomb Illinois
United States University of Wisconsin Carbone Cancer Center Madison Wisconsin
United States McFarland Clinic - Marshalltown Marshalltown Iowa
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Riddle Memorial Hospital Media Pennsylvania
United States Baptist Memorial Hospital and Cancer Center-Memphis Memphis Tennessee
United States Saint Luke's Cancer Institute - Meridian Meridian Idaho
United States UM Sylvester Comprehensive Cancer Center at Kendall Miami Florida
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States NYU Winthrop Hospital Mineola New York
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Memorial Medical Center Modesto California
United States Toledo Clinic Cancer Centers-Monroe Monroe Michigan
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States West Virginia University Healthcare Morgantown West Virginia
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States ProHealth D N Greenwald Center Mukwonago Wisconsin
United States The Community Hospital Munster Indiana
United States Saint Luke's Cancer Institute - Nampa Nampa Idaho
United States Edward Hospital/Cancer Center Naperville Illinois
United States Baptist Memorial Hospital and Cancer Center-Union County New Albany Mississippi
United States UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York
United States Memorial Sloan Kettering Cancer Center New York New York
United States Providence Newberg Medical Center Newberg Oregon
United States University of Kansas Cancer Center at North Kansas City Hospital North Kansas City Missouri
United States Ascension Providence Hospitals - Novi Novi Michigan
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Olathe Health Cancer Center Olathe Kansas
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Alegent Health Lakeside Hospital Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Saint Joseph Hospital - Orange Orange California
United States Providence Willamette Falls Medical Center Oregon City Oregon
United States University of Chicago Medicine-Orland Park Orland Park Illinois
United States AdventHealth East Orlando Orlando Florida
United States AdventHealth Medical Group Urology at Orlando Orlando Florida
United States AdventHealth Orlando Orlando Florida
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States University of Kansas Cancer Center-Overland Park Overland Park Kansas
United States University of Kansas Hospital-Indian Creek Campus Overland Park Kansas
United States Baptist Memorial Hospital and Cancer Center-Oxford Oxford Mississippi
United States Hope Cancer Care of Nevada-Pahrump Pahrump Nevada
United States Paoli Memorial Hospital Paoli Pennsylvania
United States Midlands Community Hospital Papillion Nebraska
United States Parker Adventist Hospital Parker Colorado
United States Illinois CancerCare-Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States University of Pennsylvania/Abramson Cancer Center Philadelphia Pennsylvania
United States Cancer Center at Saint Joseph's Phoenix Arizona
United States Ascension Via Christi - Pittsburg Pittsburg Kansas
United States Freeman Physician Group of Pittsburg Pittsburg Kansas
United States Edward Hospital/Cancer Center?Plainfield Plainfield Illinois
United States UM Sylvester Comprehensive Cancer Center at Plantation Plantation Florida
United States Oregon Health and Science University Portland Oregon
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States Illinois CancerCare-Princeton Princeton Illinois
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States MultiCare Good Samaritan Hospital Puyallup Washington
United States Saint Charles Health System-Redmond Redmond Oregon
United States Radiation Oncology Associates Reno Nevada
United States Renown Regional Medical Center Reno Nevada
United States Saint Mary's Regional Medical Center Reno Nevada
United States Valley Medical Center Renton Washington
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States UT Southwestern Clinical Center at Richardson/Plano Richardson Texas
United States Mayo Clinic in Rochester Rochester Minnesota
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Norris Cotton Cancer Center-North Saint Johnsbury Vermont
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Mercy Hospital South Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Salina Regional Health Center Salina Kansas
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States University of Utah Sugarhouse Health Center Salt Lake City Utah
United States California Pacific Medical Center-Pacific Campus San Francisco California
United States Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California
United States Mission Hope Medical Oncology - Santa Maria Santa Maria California
United States Pacific Gynecology Specialists Seattle Washington
United States Swedish Medical Center-Ballard Campus Seattle Washington
United States Swedish Medical Center-Cherry Hill Seattle Washington
United States Swedish Medical Center-First Hill Seattle Washington
United States PeaceHealth United General Medical Center Sedro-Woolley Washington
United States Providence Regional Cancer System-Shelton Shelton Washington
United States Jewish Hospital Medical Center South Shepherdsville Kentucky
United States Avera Cancer Institute Sioux Falls South Dakota
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Memorial Hospital of South Bend South Bend Indiana
United States Ascension Providence Hospitals - Southfield Southfield Michigan
United States Baptist Memorial Hospital and Cancer Center-Desoto Southhaven Mississippi
United States MultiCare Deaconess Cancer and Blood Specialty Center - Downtown Spokane Washington
United States MultiCare Deaconess Cancer and Blood Specialty Center - North Spokane Washington
United States MultiCare Deaconess Cancer and Blood Specialty Center - Valley Spokane Valley Washington
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan
United States Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States BJC Outpatient Center at Sunset Hills Sunset Hills Missouri
United States Franciscan Research Center-Northwest Medical Plaza Tacoma Washington
United States MultiCare Tacoma General Hospital Tacoma Washington
United States Holy Name Hospital Teaneck New Jersey
United States Mercy Health - Saint Anne Hospital Toledo Ohio
United States Toledo Clinic Cancer Centers-Toledo Toledo Ohio
United States University of Kansas Health System Saint Francis Campus Topeka Kansas
United States Upper Valley Medical Center Troy Ohio
United States William Beaumont Hospital - Troy Troy Michigan
United States Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho
United States Memorial Sloan Kettering Nassau Uniondale New York
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Northbay Cancer Center Vacaville California
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States MD Anderson Cancer Center at Cooper-Voorhees Voorhees New Jersey
United States Providence Saint Mary Regional Cancer Center Walla Walla Washington
United States Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Illinois CancerCare - Washington Washington Illinois
United States Mercy Hospital Washington Washington Missouri
United States Sibley Memorial Hospital Washington District of Columbia
United States ProHealth Waukesha Memorial Hospital Waukesha Wisconsin
United States UW Cancer Center at ProHealth Care Waukesha Wisconsin
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Methodist West Hospital West Des Moines Iowa
United States Marshfield Medical Center - Weston Weston Wisconsin
United States University of Kansas Hospital-Westwood Cancer Center Westwood Kansas
United States AdventHealth Winter Park Winter Park Florida
United States Lankenau Medical Center Wynnewood Pennsylvania
United States North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington
United States Providence Regional Cancer System-Yelm Yelm Washington
United States Rush-Copley Healthcare Center Yorkville Illinois
United States Huron Gastroenterology PC Ypsilanti Michigan
United States Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other RFS and OS differences in patients who had R1 vs R0 resections Up to 10 years
Other RFS and OS differences in patients who had lymph node positivity at resection Up to 10 years
Other RFS and OS differences in patients who had elevated or rising CA 19-9 or CEA 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. Up to 10 years
Other RFS and OS differences with those who had resectable disease at diagnosis Will be compared to those who did not. Up to 10 years
Primary Improvement in relapse-free survival (RFS) 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. From randomization to first documentation of disease recurrence (primary tumor relapse) or death, assessed from 22 months to 44 months
Secondary RFS 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. From randomization to first documentation of disease recurrence (primary tumor relapse) or death, assessed up to 5 years
Secondary Overall survival (OS) 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. From randomization until 10 years after registration or until death, whichever comes first
Secondary Efficacy of olaparib after chemotherapy in patients with a pathogenic germline BRCA or PALB2 mutation 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. Up to 10 years
Secondary Differences in survival Will analyze survival differences between patients who received neoadjuvant or perioperative chemotherapy compared to those who received adjuvant therapy alone. Up to 10 years
Secondary RFS in those who received =< 3 months of perioperative platinum chemotherapy compared to > 3 months of perioperative platinum chemotherapy 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. From randomization to first documentation of disease recurrence (primary tumor relapse) or death, assessed up to 5 years
Secondary OS in those who received =< 3 months of perioperative platinum chemotherapy versus > 3 months of perioperative platinum chemotherapy 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. From randomization until 10 years after registration or until death, whichever comes first
Secondary RFS in those who received any platinum-based perioperative chemotherapy versus no platinum-based perioperative chemotherapy 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. From randomization to first documentation of disease recurrence (primary tumor relapse) or death, assessed up to 5 years
Secondary OS in those who received any platinum-based perioperative chemotherapy versus no platinum-based perioperative chemotherapy 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. From randomization until 10 years after registration or until death, whichever comes first
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