Gallbladder Cancer
EA2197 / OPT-IN
Comparison of Chemotherapy before and after Surgery versus after Surgery Alone for the Treatment of Gallbladder Cancer, OPT-IN Trial
STATUS: Active
This phase II/III trial compares the effect of adding chemotherapy before and after surgery versus after surgery alone (usual treatment) in treating patients with stage II-III gallbladder cancer. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before surgery may make the tumor smaller; therefore, may reduce the extent of surgery. Additionally, it may make it easier for the surgeon to distinguish between normal and cancerous tissue. Giving chemotherapy after surgery may kill any remaining tumor cells. This study will determine whether giving chemotherapy before surgery increases the length of time before the cancer may return and whether it will increase a patient’s life span compared to the usual approach.
- Patient must be >= 18 years of age
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Patient must have histologically-confirmed T2 or T3 gallbladder cancer discovered incidentally at the time of or following routine cholecystectomy for presumed benign disease * NOTE: Patients with histologically-confirmed Tis, T1a, T1b, or T4 tumors are not eligible
- Patient must have undergone initial cholecystectomy within 12 weeks prior to randomization
- Patient must not have any evidence of metastatic disease or inoperable loco-regional disease based on high-quality, preoperative, cross-sectional imaging (computed tomography [CT] or magnetic resonance imaging [MRI]) of the chest, abdomen, and pelvis (C/A/P) obtained within 6 weeks prior to randomization, defined as * No radiographic evidence of distant disease (M1 disease) * No radiographic evidence of tumor invasion into multiple extrahepatic organs (T4 disease) * No radiographic evidence of distant lymph node involvement (celiac, para-aortic, para-caval lymph nodes) * No evidence of new-onset ascites * Soft tissue thickening within or in direct communication with the gallbladder fossa, peri-portal lymph node involvement, involvement of one extrahepatic organ, and other disease within the confines of what constitutes ‘localized resectable’ disease are allowable
- Women must not be pregnant or breast feeding due to the potential harm to unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of child bearing potential must have a serum or urine pregnancy test to rule out pregnancy within 14 days prior to randomization. A female of childbearing potential is defined as any woman, 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)
- Women of childbearing potential and sexually active males must not expect to conceive or father children by being strongly advised to use accepted and effective method(s) of contraception or to abstain from sexual intercourse for the duration of their participation in the study
- 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
- Absolute neutrophil count >= 1,500/mcL (obtained =< 28 days prior to randomization)
- Platelets >= 100,000/mcL (obtained =< 28 days prior to randomization)
- Total bilirubin =< institutional upper limit of normal (ULN) except in patients with Gilbert’s syndrome. Patients with Gilbert’s syndrome are eligible if direct bilirubin < 1.5 x ULN of the direct bilirubin (obtained =< 28 days prior to randomization)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained =< 28 days prior to randomization)
- Serum creatinine =< institutional ULN OR creatinine clearance >= 50 mL/min/1.73 m^2 (Based on Cockcroft Gault estimation) (obtained =< 28 days prior to randomization)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization 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
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients should be class 2B or better
United States
AK
Anchorage
Alaska Breast Care and Surgery LLC
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org
Alaska Oncology and Hematology LLC
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Email: AKPAMC.OncologyResearchSupport@providence.org
Alaska Women's Cancer Care
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Email: AKPAMC.OncologyResearchSupport@providence.org
Anchorage Associates in Radiation Medicine
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Email: AKPAMC.OncologyResearchSupport@providence.org
Anchorage Oncology Centre
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Email: AKPAMC.OncologyResearchSupport@providence.org
Anchorage Radiation Therapy Center
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Email: AKPAMC.OncologyResearchSupport@providence.org
Katmai Oncology Group
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Email: AKPAMC.OncologyResearchSupport@providence.org
Providence Alaska Medical Center
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Email: AKPAMC.OncologyResearchSupport@providence.org
AL
Birmingham
University of Alabama at Birmingham Cancer Center
Contact: Site Public Contact
Email: tmyrick@uab.edu
AR
Ft. Smith
Mercy Hospital Fort Smith
Contact: Site Public Contact
Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
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Email: ResearchInstituteInquiries@CommonSpirit.org
Jonesboro
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
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Email: Emily.Carvell@bmhcc.org
Little Rock
CARTI Cancer Center
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Email: Research@CARTI.com
University of Arkansas for Medical Sciences
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AZ
Phoenix
Cancer Center at Saint Joseph's
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Email: ResearchInstituteInquiries@CommonSpirit.org
CA
Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
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Email: ResearchInstituteInquiries@CommonSpirit.org
Burbank
Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Email: Najee.Boucher@providence.org
Carmichael
Mercy Cancer Center - Carmichael
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Email: ResearchInstituteInquiries@CommonSpirit.org
Mercy San Juan Medical Center
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Email: OncologyResearch@DignityHealth.org
Elk Grove
Mercy Cancer Center - Elk Grove
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Email: ResearchInstituteInquiries@CommonSpirit.org
Los Angeles
Cedars Sinai Medical Center
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Napa
Providence Queen of The Valley
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Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
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Email: ucstudy@uci.edu
Palo Alto
Stanford Cancer Institute Palo Alto
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Email: ccto-office@stanford.edu
Rocklin
Mercy Cancer Center - Rocklin
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Email: ResearchInstituteInquiries@CommonSpirit.org
Sacramento
Mercy Cancer Center - Sacramento
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Email: ResearchInstituteInquiries@CommonSpirit.org
University of California Davis Comprehensive Cancer Center
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San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
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Email: ResearchInstituteInquiries@CommonSpirit.org
Santa Maria
Mission Hope Medical Oncology - Santa Maria
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Email: ResearchInstituteInquiries@CommonSpirit.org
Santa Rosa
Providence Medical Foundation - Santa Rosa
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Providence Santa Rosa Memorial Hospital
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Torrance
Torrance Memorial Medical Center
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Torrance Memorial Physician Network - Cancer Care
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Email: courtney.steeneken@tmphysicians.com
Woodland
Woodland Memorial Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org
CO
Colorado Springs
Penrose-Saint Francis Healthcare
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Email: ResearchInstituteInquiries@CommonSpirit.org
Rocky Mountain Cancer Centers-Penrose
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Email: ResearchInstituteInquiries@CommonSpirit.org
Saint Francis Cancer Center
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Email: ResearchInstituteInquiries@CommonSpirit.org
Denver
Porter Adventist Hospital
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Email: ResearchTracking@Centura.Org
Durango
Mercy Medical Center
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Email: ResearchInstituteInquiries@CommonSpirit.org
Southwest Oncology PC
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Email: ResearchInstituteInquiries@CommonSpirit.org
Lakewood
Saint Anthony Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org
Littleton
Littleton Adventist Hospital
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Email: ResearchTracking@Centura.Org
Longmont
Longmont United Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org
Rocky Mountain Cancer Centers-Longmont
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Email: ResearchTracking@Centura.Org
Parker
Parker Adventist Hospital
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Email: ResearchTracking@Centura.Org
Pueblo
Saint Mary Corwin Medical Center
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Email: ResearchInstituteInquiries@CommonSpirit.org
FL
Aventura
UM Sylvester Comprehensive Cancer Center at Aventura
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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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Fort Myers
Regional Cancer Center-Lee Memorial Health System
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Gainesville
University of Florida Health Science Center - Gainesville
Contact: Site Public Contact
Email: cancer-center@ufl.edu
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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Plantation
UM Sylvester Comprehensive Cancer Center at Plantation
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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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Braselton
Northeast Georgia Medical Center Braselton
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Email: cancerpatient.navigator@nghs.com
Gainesville
Northeast Georgia Medical Center-Gainesville
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Email: cancerpatient.navigator@nghs.com
Savannah
Low Country Cancer Care
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Email: Lorraine.OHara@hcahealthcare.com
Memorial Health University Medical Center
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Email: Lorraine.OHara@hcahealthcare.com
Summit Cancer Care-Memorial
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Email: Lorraine.OHara@hcahealthcare.com
IA
Ankeny
Mission Cancer and Blood - Ankeny
Contact: Site Public Contact
Carroll
Saint Anthony Regional Hospital
Contact: Site Public Contact
Email: sbenson@iora.org
Clive
Mercy Cancer Center-West Lakes
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Email: cancerresearch@mercydesmoines.org
Mission Cancer and Blood - West Des Moines
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Council Bluffs
Alegent Health Mercy Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org
Creston
Greater Regional Medical Center
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Email: cancerresearch@mercydesmoines.org
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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Email: cancerresearch@mercydesmoines.org
Mission Cancer and Blood - Des Moines
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Mission Cancer and Blood - Laurel
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Fort Dodge
Trinity Regional Medical Center
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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
Contact: Site Public Contact
Email: eslinget@slhs.org
Fruitland
Saint Luke's Cancer Institute - Fruitland
Contact: Site Public Contact
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
OSF Saint Anthony's Health Center
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Aurora
Rush - Copley Medical Center
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com
Bloomington
Illinois CancerCare-Bloomington
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Canton
Illinois CancerCare-Canton
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Carbondale
Memorial Hospital of Carbondale
Contact: Site Public Contact
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
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Saint Mary's Hospital
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Chicago
Northwestern University
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Email: cancer@northwestern.edu
University of Chicago Comprehensive Cancer Center
Contact: Site Public Contact
Email: cancerclinicaltrials@bsd.uchicago.edu
University of Illinois
Contact: Site Public Contact
Danville
Carle at The Riverfront
Contact: Site Public Contact
Email: Research@Carle.com
DeKalb
Northwestern Medicine Cancer Center Kishwaukee
Contact: Site Public Contact
Email: Donald.Smith3@nm.org
Decatur
Cancer Care Specialists of Illinois - Decatur
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Decatur Memorial Hospital
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Dixon
Illinois CancerCare-Dixon
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Effingham
Carle Physician Group-Effingham
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Email: Research@carle.com
Crossroads Cancer Center
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Email: morganthaler.jodi@mhsil.com
Elmhurst
Elmhurst Memorial Hospital
Contact: Site Public Contact
Email: Jrohde@emhc.org
Eureka
Illinois CancerCare-Eureka
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Galesburg
Illinois CancerCare-Galesburg
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Email: andersonj@illinoiscancercare.com
Western Illinois Cancer Treatment Center
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Geneva
Northwestern Medicine Cancer Center Delnor
Contact: Site Public Contact
Email: Donald.Smith3@nm.org
Kewanee
Illinois CancerCare-Kewanee Clinic
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Macomb
Illinois CancerCare-Macomb
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Mattoon
Carle Physician Group-Mattoon/Charleston
Contact: Site Public Contact
Email: Research@carle.com
Mount Vernon
Good Samaritan Regional Health Center
Contact: Site Public Contact
Naperville
Edward Hospital/Cancer Center
Contact: Site Public Contact
New Lenox
UC Comprehensive Cancer Center at Silver Cross
Contact: Site Public Contact
Email: cancerclinicaltrials@bsd.uchicago.edu
O'Fallon
Cancer Care Center of O'Fallon
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
HSHS Saint Elizabeth's Hospital
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Orland Park
University of Chicago Medicine-Orland Park
Contact: Site Public Contact
Email: cancerclinicaltrials@bsd.uchicago.edu
Ottawa
Illinois CancerCare-Ottawa Clinic
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Pekin
Illinois CancerCare-Pekin
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
OSF Saint Francis Radiation Oncology at Pekin
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Peoria
Illinois CancerCare-Peoria
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Methodist Medical Center of Illinois
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
OSF Saint Francis Medical Center
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Peru
Illinois CancerCare-Peru
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Valley Radiation Oncology
Contact: Site Public Contact
Plainfield
Edward Hospital/Cancer Center?Plainfield
Contact: Site Public Contact
Email: Cancerresearch@edward.org
Princeton
Illinois CancerCare-Princeton
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Springfield
Southern Illinois University School of Medicine
Contact: Site Public Contact
Springfield Clinic
Contact: Site Public Contact
Springfield Memorial Hospital
Contact: Site Public Contact
Email: pallante.beth@mhsil.com
Urbana
Carle Cancer Center
Contact: Site Public Contact
Email: Research@carle.com
Warrenville
Northwestern Medicine Cancer Center Warrenville
Contact: Site Public Contact
Email: Donald.Smith3@nm.org
Washington
Illinois CancerCare - Washington
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Yorkville
Rush-Copley Healthcare Center
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com
IN
Richmond
Reid Health
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
KS
Garden City
Central Care Cancer Center - Garden City
Contact: Site Public Contact
Email: aroland@kccop.org
Great Bend
Central Care Cancer Center - Great Bend
Contact: Site Public Contact
Email: aroland@kccop.org
KY
Bardstown
Flaget Memorial Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Corbin
Commonwealth Cancer Center-Corbin
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Lexington
Saint Joseph Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org
Saint Joseph Hospital East
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Email: ResearchInstituteInquiries@CommonSpirit.org
Saint Joseph Radiation Oncology Resource Center
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Email: ResearchInstituteInquiries@CommonSpirit.org
University of Kentucky/Markey Cancer Center
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London
Saint Joseph London
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Louisville
Jewish Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org
Saints Mary and Elizabeth Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org
The James Graham Brown Cancer Center at University of Louisville
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UofL Health Medical Center Northeast
Contact: Site Public Contact
Email: ctoinfo@louisville.edu
Mount Sterling
Saint Joseph Mount Sterling
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Email: ResearchInstituteInquiries@CommonSpirit.org
Shepherdsville
Jewish Hospital Medical Center South
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Email: ResearchInstituteInquiries@CommonSpirit.org
MA
Lowell
Lowell General Hospital
Contact: Site Public Contact
Email: ghincks@lowellgeneral.org
Worcester
UMass Memorial Medical Center - University Campus
Contact: Site Public Contact
Email: cancer.research@umassmed.edu
MI
Ann Arbor
University of Michigan Comprehensive Cancer Center
Contact: Site Public Contact
Battle Creek
Bronson Battle Creek
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org
Brighton
University of Michigan - Brighton Center for Specialty Care
Contact: Site Public Contact
Grand Rapids
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org
Trinity Health Grand Rapids Hospital
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Email: crcwm-regulatory@crcwm.org
Kalamazoo
Ascension Borgess Cancer Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org
Ascension Borgess Hospital
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Email: crcwm-regulatory@crcwm.org
Bronson Methodist Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org
West Michigan Cancer Center
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Email: crcwm-regulatory@crcwm.org
Muskegon
Trinity Health Muskegon Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org
Niles
Corewell Health Lakeland Hospitals - Niles Hospital
Contact: Site Public Contact
Norton Shores
Cancer and Hematology Centers of Western Michigan - Norton Shores
Contact: Site Public Contact
Email: connie.szczepanek@crcwm.org
Reed City
Corewell Health Reed City Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org
Saint Joseph
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org
Traverse City
Munson Medical Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org
Wyoming
University of Michigan Health - West
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org
MN
Bemidji
Sanford Joe Lueken Cancer Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Rochester
Mayo Clinic in Rochester
Contact: Site Public Contact
Thief River Falls
Sanford Thief River Falls Medical Center
Contact: Site Public Contact
Worthington
Sanford Cancer Center Worthington
Contact: Site Public Contact
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
Branson
Cox Cancer Center Branson
Contact: Site Public Contact
Cape Girardeau
Saint Francis Medical Center
Contact: Site Public Contact
Email: sfmc@sfmc.net
Southeast Cancer Center
Contact: Site Public Contact
Creve Coeur
Siteman Cancer Center at West County Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu
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
Osage Beach
Lake Regional Hospital
Contact: Site Public Contact
Email: clinicaltrials@lakeregional.com
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: Trisha.England2@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
Siteman Cancer Center at Christian Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu
Siteman Cancer Center-South County
Contact: Site Public Contact
Email: info@siteman.wustl.edu
Washington University School of Medicine
Contact: Site Public Contact
Email: info@siteman.wustl.edu
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu
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
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
Cary
Duke Cancer Institute Cary
Contact: Site Public Contact
Durham
Duke University Medical Center
Contact: Site Public Contact
Greenville
East Carolina University
Contact: Site Public Contact
Email: eubankss@ecu.edu
Raleigh
Duke Raleigh Hospital
Contact: Site Public Contact
Winston-Salem
Wake Forest University Health Sciences
Contact: Site Public Contact
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 Medical Center Fargo
Contact: Site Public Contact
Sanford Roger Maris Cancer Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Sanford South University Medical Center
Contact: Site Public Contact
Southpointe-Sanford Medical Center Fargo
Contact: Site Public Contact
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
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Email: ResearchInstituteInquiries@CommonSpirit.org
Alegent Health Lakeside Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Creighton University Medical Center
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Email: ResearchInstituteInquiries@CommonSpirit.org
Papillion
Midlands Community Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
NJ
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Contact: Site Public Contact
Elizabeth
Trinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus
Contact: Site Public Contact
Hamilton
The Cancer Institute of New Jersey Hamilton
Contact: Site Public Contact
Jersey City
Jersey City Medical Center
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Lakewood
Monmouth Medical Center Southern Campus
Contact: Site Public Contact
Email: mary.danish@rwjbh.org
Livingston
Saint Barnabas Medical Center
Contact: Site Public Contact
Email: joanne.loeb@rwjbh.org
Long Branch
Monmouth Medical Center
Contact: Site Public Contact
Email: mary.danish@rwjbh.org
Middletown
Memorial Sloan Kettering Monmouth
Contact: Site Public Contact
Montvale
Memorial Sloan Kettering Bergen
Contact: Site Public Contact
New Brunswick
Rutgers Cancer Institute of New Jersey
Contact: Site Public Contact
Newark
Newark Beth Israel Medical Center
Contact: Site Public Contact
Email: Christine.Kosmides@rwjbh.org
Rutgers New Jersey Medical School
Contact: Site Public Contact
Somerville
Robert Wood Johnson University Hospital Somerset
Contact: Site Public Contact
Email: Siby.Varughese@rwjbh.org
Toms River
Community Medical Center
Contact: Site Public Contact
Email: Lennette.Gonzales@rwjbh.org
NM
Albuquerque
Lovelace Medical Center-Saint Joseph Square
Contact: Site Public Contact
Email: AYost@nmcca.org
Presbyterian Kaseman Hospital
Contact: Site Public Contact
Email: WBurman@phs.org
University of New Mexico Cancer Center
Contact: Site Public Contact
Email: HSC-ClinicalTrialInfo@salud.unm.edu
Rio Rancho
Presbyterian Rust Medical Center/Jorgensen Cancer Center
Contact: Site Public Contact
Email: WBurman@phs.org
NY
Albany
Albany Medical Center
Contact: Site Public Contact
Commack
Memorial Sloan Kettering Commack
Contact: Site Public Contact
Lake Success
Northwell Health/Center for Advanced Medicine
Contact: Site Public Contact
Manhasset
North Shore University Hospital
Contact: Site Public Contact
Mineola
NYU Langone Hospital - Long Island
Contact: Site Public Contact
Email: cancertrials@nyulangone.org
New Hyde Park
Long Island Jewish Medical Center
Contact: Site Public Contact
New York
Memorial Sloan Kettering Cancer Center
Contact: Site Public Contact
Rego Park
Queens Cancer Center
Contact: Site Public Contact
Rochester
Highland Hospital
Contact: Site Public Contact
University of Rochester
Contact: Site Public Contact
Stony Brook
Stony Brook University Medical Center
Contact: Site Public Contact
Uniondale
Memorial Sloan Kettering Nassau
Contact: Site Public Contact
West Harrison
Memorial Sloan Kettering Westchester
Contact: Site Public Contact
OH
Beavercreek
Indu and Raj Soin Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Boardman
Saint Elizabeth Boardman Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Centerville
Dayton Physicians LLC-Miami Valley South
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
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
Oncology Hematology Care Inc-Kenwood
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.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
Cleveland
MetroHealth Medical Center
Contact: Site Public Contact
Email: ababal@metrohealth.org
Columbus
Ohio State University Comprehensive Cancer Center
Contact: Site Public Contact
Email: Jamesline@osumc.edu
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
Findlay
Armes Family Cancer Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Blanchard Valley Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Orion Cancer Care
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Franklin
Atrium Medical Center-Middletown Regional Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Dayton Physicians LLC-Atrium
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Greenville
Dayton Physicians LLC-Wayne
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Miami Valley Cancer Care and Infusion
Contact: Site Public Contact
Wayne Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Kettering
Greater Dayton Cancer Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Kettering Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Springfield
Springfield Regional Cancer Center
Contact: Site Public Contact
Email: Jeffh@columbusccop.org
Springfield Regional Medical Center
Contact: Site Public Contact
Email: Jeffh@columbusccop.org
Troy
Dayton Physicians LLC - Troy
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Upper Valley Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Warren
Saint Joseph Warren Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Youngstown
Saint Elizabeth Youngstown Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
OK
Oklahoma City
Mercy Hospital Oklahoma City
Contact: Site Public Contact
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
Gresham
Legacy Mount Hood Medical Center
Contact: Site Public Contact
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
Legacy Good Samaritan Hospital and Medical Center
Contact: Site Public Contact
Email: cancer@lhs.org
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
Tualatin
Legacy Meridian Park Hospital
Contact: Site Public Contact
PA
Hershey
Penn State Milton S Hershey Medical Center
Contact: Site Public Contact
Email: CTO@hmc.psu.edu
Philadelphia
Thomas Jefferson University Hospital
Contact: Site Public Contact
Email: ONCTrialNow@jefferson.edu
University of Pennsylvania/Abramson Cancer Center
Contact: Site Public Contact
Email: PennCancerTrials@careboxhealth.com
SC
Charleston
Bon Secours Saint Francis Hospital
Contact: Site Public Contact
Email: Courtney.Roldan@RoperSaintFrancis.com
Charleston Oncology - Roper
Contact: Site Public Contact
Email: Heather.Dubose@choasc.com
Charleston Oncology - Saint Francis
Contact: Site Public Contact
Email: Heather.Dubose@choasc.com
Medical University of South Carolina
Contact: Site Public Contact
Email: hcc-clinical-trials@musc.edu
Roper Hospital
Contact: Site Public Contact
Email: Courtney.Roldan@RoperSaintFrancis.com
SD
Sioux Falls
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
Franklin
Vanderbilt-Ingram Cancer Center Cool Springs
Contact: Site Public Contact
Vanderbilt-Ingram Cancer Center at Franklin
Contact: Site Public Contact
Knoxville
University of Tennessee - Knoxville
Contact: Site Public Contact
Memphis
Baptist Memorial Hospital and Cancer Center-Memphis
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org
Nashville
Vanderbilt Breast Center at One Hundred Oaks
Contact: Site Public Contact
Vanderbilt University/Ingram Cancer Center
Contact: Site Public Contact
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-Dallas
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
San Antonio
University of Texas Health Science Center at San Antonio
Contact: Site Public Contact
Email: phoresearchoffice@uthscsa.edu
VA
Fairfax
Inova Schar Cancer Institute
Contact: Site Public Contact
Email: Stephanie.VanBebber@inova.org
Falls Church
Inova Fairfax Hospital
Contact: Site Public Contact
Email: Stephanie.VanBebber@inova.org
WA
Aberdeen
Providence Regional Cancer System-Aberdeen
Contact: Site Public Contact
Email: deidre.dillon@providence.org
Bellingham
PeaceHealth Saint Joseph Medical Center
Contact: Site Public Contact
Bremerton
Harrison HealthPartners Hematology and Oncology-Bremerton
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org
Burien
Highline Medical Center-Main Campus
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Centralia
Providence Regional Cancer System-Centralia
Contact: Site Public Contact
Email: deidre.dillon@providence.org
Edmonds
Swedish Cancer Institute-Edmonds
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Enumclaw
Saint Elizabeth Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Everett
Providence Regional Cancer Partnership
Contact: Site Public Contact
Email: marilyn.birchman@providence.org
Federal Way
Saint Francis Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Issaquah
Swedish Cancer Institute-Issaquah
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Kennewick
Kadlec Clinic Hematology and Oncology
Contact: Site Public Contact
Email: research@kadlecmed.org
Lacey
Providence Regional Cancer System-Lacey
Contact: Site Public Contact
Email: deidre.dillon@providence.org
Lakewood
Saint Clare Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Longview
PeaceHealth Saint John Medical Center
Contact: Site Public Contact
Email: kmakin-bond@peacehealth.org
Poulsbo
Harrison HealthPartners Hematology and Oncology-Poulsbo
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org
Seattle
Pacific Gynecology Specialists
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-Ballard Campus
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-Cherry Hill
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-First Hill
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Virginia Mason Medical Center
Contact: Site Public Contact
Email: cancerresearch@virginiamason.org
Sedro-Woolley
PeaceHealth United General Medical Center
Contact: Site Public Contact
Email: rcrompton@peacehealth.org
Shelton
Providence Regional Cancer System-Shelton
Contact: Site Public Contact
Email: deidre.dillon@providence.org
Silverdale
Saint Michael Cancer Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Tacoma
Franciscan Research Center-Northwest Medical Plaza
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Northwest Medical Specialties PLLC
Contact: Site Public Contact
Email: research@southsoundcare.org
Vancouver
Legacy Cancer Institute Medical Oncology and Day Treatment
Contact: Site Public Contact
Email: oncologyresearch@lhs.org
Legacy Salmon Creek Hospital
Contact: Site Public Contact
PeaceHealth Southwest Medical Center
Contact: Site Public Contact
Email: kmakin-bond@peacehealth.org
Walla Walla
Providence Saint Mary Regional Cancer Center
Contact: Site Public Contact
Email: Cheryl.Dodd@providence.org
Yelm
Providence Regional Cancer System-Yelm
Contact: Site Public Contact
Email: deidre.dillon@providence.org
WI
Eau Claire
Marshfield Medical Center-EC Cancer Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
La Crosse
Gundersen Lutheran Medical Center
Contact: Site Public Contact
Email: cancerctr@gundersenhealth.org
Madison
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Contact: Site Public Contact
Email: clinicaltrials@cancer.wisc.edu
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 Medical Center - Minocqua
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Rice Lake
Marshfield Medical Center-Rice Lake
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Weston
Marshfield Medical Center - Weston
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
WV
Bridgeport
United Hospital Center
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu
Martinsburg
WVUH-Berkely Medical Center
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu
Morgantown
West Virginia University Healthcare
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu
Parkersburg
Camden Clark Medical Center
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu
PRIMARY OBJECTIVE: I. To determine the difference in overall survival (OS) for patients given neoadjuvant gemcitabine hydrochloride (gemcitabine) and cisplatin prior to re-resection followed by adjuvant gemcitabine and cisplatin compared to patients who receive only adjuvant gemcitabine and cisplatin after re-resection for incidental gallbladder cancer (IGBC). SECONDARY OBJECTIVES: I. To compare the incidence of residual disease at the time of re-resection between patients with IGBC who receive perioperative chemotherapy prior to re-resection and those who receive only adjuvant chemotherapy after re-resection. II. To assess the clinical effect of preoperative chemotherapy compared to upfront re-resection on resectability among 3 cohorts: all enrolled patients, all patients who undergo staging laparoscopy, and all patients who undergo laparotomy. III. To determine the difference in progression-free survival (PFS) for patients with IGBC who receive perioperative chemotherapy prior to and after re-resection compared to patients who receive only adjuvant chemotherapy after re-resection. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Within 4 weeks of randomization, patients undergo surgery to remove part of the liver, the lymph nodes around the liver, and possibly the bile ducts. Within 16 weeks after completion of surgery, patients then receive gemcitabine intravenously (IV) over 30 minutes and cisplatin IV over 30 minutes-24 hours on days 1 and 8. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) and magnetic resonance imaging (MRI) on study. ARM II: Patients receive gemcitabine IV over 30 minutes and cisplatin over 30 minutes-24 hours on days 1 and 8. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Approximately 4-8 weeks after completion of chemotherapy, patients whose disease has not spread to other places in the body (metastasized) undergo surgery as in Arm I. Patients with successful surgery then resume treatment with gemcitabine IV and cisplatin IV on days 1 and 8. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT and MRI during baseline and on study. After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for 1 year after surgery or until disease recurrence, whichever comes first, for up to 5 years.
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.