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 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

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

  • 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
Status: ACTIVE
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Alaska Oncology and Hematology LLC
Status: ACTIVE
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Alaska Women's Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Associates in Radiation Medicine
Status: ACTIVE
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Oncology Centre
Status: ACTIVE
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Radiation Therapy Center
Status: ACTIVE
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Katmai Oncology Group
Status: ACTIVE
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Providence Alaska Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

AL
Birmingham
University of Alabama at Birmingham Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: tmyrick@uab.edu

AR
Ft. Smith
Mercy Hospital Fort Smith
Status: ACTIVE
Contact: Site Public Contact

Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Jonesboro
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Status: ACTIVE
Contact: Site Public Contact
Email: Emily.Carvell@bmhcc.org

Little Rock
University of Arkansas for Medical Sciences
Status: ACTIVE
Contact: Site Public Contact

AZ
Phoenix
Cancer Center at Saint Joseph's
Status: ACTIVE
Contact: Site Public Contact
Email: CancerInstitute@DignityHealth.org

CA
Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: Najee.Boucher@providence.org

Los Angeles
Cedars Sinai Medical Center
Status: ACTIVE
Contact: Site Public Contact

Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: ucstudy@uci.edu

Palo Alto
Stanford Cancer Institute Palo Alto
Status: ACTIVE
Contact: Site Public Contact
Email: ccto-office@stanford.edu

Sacramento
University of California Davis Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact

San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Santa Maria
Mission Hope Medical Oncology - Santa Maria
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Torrance
Torrance Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact

Torrance Memorial Physician Network - Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Email: courtney.steeneken@tmphysicians.com

CO
Colorado Springs
Penrose-Saint Francis Healthcare
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Rocky Mountain Cancer Centers-Penrose
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Saint Francis Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Denver
Porter Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Durango
Mercy Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Southwest Oncology PC
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Lakewood
Saint Anthony Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Littleton
Littleton Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Longmont
Longmont United Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Rocky Mountain Cancer Centers-Longmont
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Parker
Parker Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Pueblo
Saint Mary Corwin Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

FL
Aventura
UM Sylvester Comprehensive Cancer Center at Aventura
Status: ACTIVE
Contact: Site Public Contact

Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
Status: ACTIVE
Contact: Site Public Contact

Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Status: ACTIVE
Contact: Site Public Contact

Fort Myers
Regional Cancer Center-Lee Memorial Health System
Status: ACTIVE
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Gainesville
University of Florida Health Science Center - Gainesville
Status: ACTIVE
Contact: Site Public Contact
Email: cancer-center@ufl.edu

Miami
UM Sylvester Comprehensive Cancer Center at Kendall
Status: ACTIVE
Contact: Site Public Contact

University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Plantation
UM Sylvester Comprehensive Cancer Center at Plantation
Status: ACTIVE
Contact: Site Public Contact

GA
Atlanta
Emory Saint Joseph's Hospital
Status: ACTIVE
Contact: Site Public Contact

Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Contact: Site Public Contact

Emory University Hospital Midtown
Status: ACTIVE
Contact: Site Public Contact

Savannah
Low Country Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Email: Lorraine.OHara@hcahealthcare.com

Memorial Health University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: Lorraine.OHara@hcahealthcare.com

Summit Cancer Care-Memorial
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Lorraine.OHara@hcahealthcare.com

IA
Carroll
Saint Anthony Regional Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: sbenson@iora.org

Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Mercy Cancer Center-West Lakes
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Council Bluffs
Alegent Health Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Creston
Greater Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Des Moines
Broadlawns Medical Center
Status: ACTIVE
Contact: Site Public Contact

Iowa Lutheran Hospital
Status: ACTIVE
Contact: Site Public Contact

Iowa Methodist Medical Center
Status: ACTIVE
Contact: Site Public Contact

Medical Oncology and Hematology Associates-Des Moines
Status: ACTIVE
Contact: Site Public Contact

Mercy Medical Center - Des Moines
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Mission Cancer and Blood - Laurel
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Fort Dodge
Trinity Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact

West Des Moines
Mercy Medical Center-West Lakes
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Methodist West Hospital
Status: ACTIVE
Contact: Site Public Contact

ID
Boise
Saint Luke's Cancer Institute - Boise
Status: ACTIVE
Contact: Site Public Contact
Email: eslinget@slhs.org

Fruitland
Saint Luke's Cancer Institute - Fruitland
Status: ACTIVE
Contact: Site Public Contact
Email: eslinget@slhs.org

Meridian
Saint Luke's Cancer Institute - Meridian
Status: ACTIVE
Contact: Site Public Contact
Email: eslinget@slhs.org

Nampa
Saint Luke's Cancer Institute - Nampa
Status: ACTIVE
Contact: Site Public Contact
Email: eslinget@slhs.org

Twin Falls
Saint Luke's Cancer Institute - Twin Falls
Status: ACTIVE
Contact: Site Public Contact
Email: eslinget@slhs.org

IL
Alton
Saint Anthony's Health
Status: ACTIVE
Contact: Site Public Contact

Bloomington
Illinois CancerCare-Bloomington
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Canton
Illinois CancerCare-Canton
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Carbondale
Memorial Hospital of Carbondale
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.research@sih.net

Carterville
SIH Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.research@sih.net

Carthage
Illinois CancerCare-Carthage
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Centralia
Centralia Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Chicago
Northwestern University
Status: APPROVED
Contact: Site Public Contact
Email: cancer@northwestern.edu

University of Chicago Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancerclinicaltrials@bsd.uchicago.edu

University of Illinois
Status: ACTIVE
Contact: Site Public Contact

DeKalb
Northwestern Medicine Cancer Center Kishwaukee
Status: ACTIVE
Contact: Site Public Contact
Email: Donald.Smith3@nm.org

Decatur
Cancer Care Specialists of Illinois - Decatur
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Dixon
Illinois CancerCare-Dixon
Status: ACTIVE
Contact: Site Public Contact

Effingham
Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Elmhurst
Elmhurst Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: Jrohde@emhc.org

Eureka
Illinois CancerCare-Eureka
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Galesburg
Illinois CancerCare-Galesburg
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Western Illinois Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact

Geneva
Northwestern Medicine Cancer Center Delnor
Status: ACTIVE
Contact: Site Public Contact
Email: Donald.Smith3@nm.org

Kewanee
Illinois CancerCare-Kewanee Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Macomb
Illinois CancerCare-Macomb
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Mount Vernon
Good Samaritan Regional Health Center
Status: ACTIVE
Contact: Site Public Contact

Naperville
Edward Hospital / Cancer Center
Status: ACTIVE
Contact: Site Public Contact

New Lenox
UC Comprehensive Cancer Center at Silver Cross
Status: ACTIVE
Contact: Site Public Contact
Email: cancerclinicaltrials@bsd.uchicago.edu

O'Fallon
Cancer Care Center of O'Fallon
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Orland Park
University of Chicago Medicine-Orland Park
Status: ACTIVE
Contact: Site Public Contact
Email: cancerclinicaltrials@bsd.uchicago.edu

Ottawa
Illinois CancerCare-Ottawa Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Pekin
Illinois CancerCare-Pekin
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peoria
Illinois CancerCare-Peoria
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Methodist Medical Center of Illinois
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

OSF Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peru
Illinois CancerCare-Peru
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Valley Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact

Plainfield
Edward Hospital / Cancer Center?Plainfield
Status: ACTIVE
Contact: Site Public Contact
Email: Cancerresearch@edward.org

Princeton
Illinois CancerCare-Princeton
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Springfield
Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: pallante.beth@mhsil.com

Southern Illinois University School of Medicine
Status: ACTIVE
Contact: Site Public Contact

Springfield Clinic
Status: ACTIVE
Contact: Site Public Contact

Warrenville
Northwestern Medicine Cancer Center Warrenville
Status: ACTIVE
Contact: Site Public Contact
Email: Donald.Smith3@nm.org

Washington
Illinois CancerCare - Washington
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

IN
Richmond
Reid Health
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

KS
Garden City
Central Care Cancer Center - Garden City
Status: ACTIVE
Contact: Site Public Contact
Email: aroland@kccop.org

Great Bend
Central Care Cancer Center - Great Bend
Status: ACTIVE
Contact: Site Public Contact
Email: aroland@kccop.org

KY
Bardstown
Flaget Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Corbin
Commonwealth Cancer Center-Corbin
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Lexington
Saint Joseph Hospital East
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Radiation Oncology Resource Center
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

University of Kentucky / Markey Cancer Center
Status: APPROVED
Contact: Site Public Contact

London
Saint Joseph London
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Louisville
Jewish Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Saints Mary and Elizabeth Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

The James Graham Brown Cancer Center at University of Louisville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

UofL Health Medical Center Northeast
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ctoinfo@louisville.edu

Shepherdsville
Jewish Hospital Medical Center South
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

MA
Lowell
Lowell General Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ghincks@lowellgeneral.org

MI
Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Battle Creek
Bronson Battle Creek
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Brighton
University of Michigan - Brighton Center for Specialty Care
Status: ACTIVE
Contact: Site Public Contact

Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Mercy Health Saint Mary's
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Spectrum Health at Butterworth Campus
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Kalamazoo
Ascension Borgess Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Borgess Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Bronson Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Muskegon
Mercy Health Mercy Campus
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Niles
Lakeland Hospital Niles
Status: ACTIVE
Contact: Site Public Contact

Norton Shores
Cancer and Hematology Centers of Western Michigan - Norton Shores
Status: ACTIVE
Contact: Site Public Contact
Email: connie.szczepanek@crcwm.org

Reed City
Spectrum Health Reed City Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Saint Joseph
Lakeland Medical Center Saint Joseph
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Marie Yeager Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Traverse City
Munson Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Wyoming
Metro Health Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

MN
Bemidji
Sanford Joe Lueken Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Site Public Contact

Thief River Falls
Sanford Thief River Falls Medical Center
Status: ACTIVE
Contact: Site Public Contact

Worthington
Sanford Cancer Center Worthington
Status: ACTIVE
Contact: Site Public Contact

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

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

Branson
Cox Cancer Center Branson
Status: ACTIVE
Contact: Site Public Contact

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

Southeast Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Creve Coeur
Siteman Cancer Center at West County Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Farmington
Parkland Health Center - Farmington
Status: ACTIVE
Contact: Site Public Contact

Jefferson City
Capital Region Southwest Campus
Status: ACTIVE
Contact: Site Public Contact
Email: swooden@mail.crmc.org

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

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

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

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

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

Saint Louis
Mercy Hospital Saint Louis
Status: ACTIVE
Contact: Site Public Contact

Mercy Hospital South
Status: ACTIVE
Contact: Site Public Contact
Email: janet.lesko@mercy.net

Missouri Baptist Medical Center
Status: ACTIVE
Contact: Site Public Contact

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

Siteman Cancer Center at Christian Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Siteman Cancer Center-South County
Status: ACTIVE
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Washington University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: info@siteman.wustl.edu

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

Springfield
CoxHealth South Hospital
Status: ACTIVE
Contact: Site Public Contact

Mercy Hospital Springfield
Status: ACTIVE
Contact: Site Public Contact

Sullivan
Missouri Baptist Sullivan Hospital
Status: ACTIVE
Contact: Site Public Contact

Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: ACTIVE
Contact: Site Public Contact

Washington
Mercy Hospital Washington
Status: ACTIVE
Contact: Site Public Contact

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

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

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

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

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

NC
Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE
Contact: Site Public Contact

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

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

Sanford Medical Center Fargo
Status: ACTIVE
Contact: Site Public Contact

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

Sanford South University Medical Center
Status: ACTIVE
Contact: Site Public Contact

Southpointe-Sanford Medical Center Fargo
Status: ACTIVE
Contact: Site Public Contact

NE
Grand Island
CHI Health Saint Francis
Status: ACTIVE
Contact: Site Public Contact

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

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

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

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

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

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

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

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

Middletown
Memorial Sloan Kettering Monmouth
Status: ACTIVE
Contact: Site Public Contact

Montvale
Memorial Sloan Kettering Bergen
Status: ACTIVE
Contact: Site Public Contact

NM
Albuquerque
Lovelace Medical Center-Saint Joseph Square
Status: ACTIVE
Contact: Site Public Contact
Email: AYost@nmcca.org

Presbyterian Kaseman Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: WBurman@phs.org

University of New Mexico Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: LByatt@nmcca.org

Rio Rancho
Presbyterian Rust Medical Center / Jorgensen Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: WBurman@phs.org

NY
Commack
Memorial Sloan Kettering Commack
Status: ACTIVE
Contact: Site Public Contact

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

Manhasset
North Shore University Hospital
Status: ACTIVE
Contact: Site Public Contact

New Hyde Park
Long Island Jewish Medical Center
Status: ACTIVE
Contact: Site Public Contact

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Rochester
Highland Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

University of Rochester
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Stony Brook
Stony Brook University Medical Center
Status: ACTIVE
Contact: Site Public Contact

Uniondale
Memorial Sloan Kettering Nassau
Status: ACTIVE
Contact: Site Public Contact

West Harrison
Memorial Sloan Kettering Westchester
Status: ACTIVE
Contact: Site Public Contact

OH
Beavercreek
Indu and Raj Soin Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Boardman
Saint Elizabeth Boardman Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Centerville
Dayton Physicians LLC-Miami Valley South
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

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

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

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

Oncology Hematology Care Inc-Kenwood
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

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

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

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: Jamesline@osumc.edu

Dayton
Dayton Physician LLC-Miami Valley Hospital North
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

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

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

Findlay
Armes Family Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Blanchard Valley Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Orion Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

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

Dayton Physicians LLC-Atrium
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Greenville
Dayton Physicians LLC-Wayne
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Wayne Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Kettering
Greater Dayton Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

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

Springfield
Springfield Regional Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Springfield Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Troy
Dayton Physicians LLC-Upper Valley
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

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

Warren
Saint Joseph Warren Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Youngstown
Saint Elizabeth Youngstown Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

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

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

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

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

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

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

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

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

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

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

PA
Hershey
Penn State Milton S Hershey Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: CTO@hmc.psu.edu

Philadelphia
Thomas Jefferson University Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ONCTrialNow@jefferson.edu

University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE
Contact: Site Public Contact

SC
Charleston
Medical University of South Carolina
Status: ACTIVE
Contact: Site Public Contact
Email: hcc-clinical-trials@musc.edu

SD
Sioux Falls
Sanford Cancer Center Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: OncologyClinicTrialsSF@sanfordhealth.org

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

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

Franklin
Vanderbilt-Ingram Cancer Center Cool Springs
Status: ACTIVE
Contact: Site Public Contact

Vanderbilt-Ingram Cancer Center at Franklin
Status: ACTIVE
Contact: Site Public Contact

Knoxville
University of Tennessee - Knoxville
Status: ACTIVE
Contact: Site Public Contact

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

Nashville
Vanderbilt Breast Center at One Hundred Oaks
Status: ACTIVE
Contact: Site Public Contact

Vanderbilt University / Ingram Cancer Center
Status: ACTIVE
Contact: Site Public Contact

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

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

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

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

VA
Fairfax
Inova Schar Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Email: Stephanie.VanBebber@inova.org

Falls Church
Inova Fairfax Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: Stephanie.VanBebber@inova.org

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

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

Madison
University of Wisconsin Carbone Cancer Center
Status: ACTIVE
Contact: Site Public Contact

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

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

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

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

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

WV
Bridgeport
United Hospital Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu

Martinsburg
WVUH-Berkely Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu

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

Parkersburg
Camden Clark Medical Center
Status: ACTIVE
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. 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.

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.

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.


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ECOG-ACRIN Cancer Research Group