AzTrials
AzTrials

Stage II Gallbladder Cancer AJCC v8Phase 2/3NCT04559139

Comparison of Chemotherapy Before and After Surgery Versus After Surgery Alone for the Treatment of Gallbladder Cancer

A Phase 2/3 study testing Cisplatin, Gemcitabine Hydrochloride and Lymphadenectomy in people with Stage II Gallbladder Cancer AJCC v8 and Stage IIA Gallbladder Cancer AJCC v8, run by ECOG-ACRIN Cancer Research Group at 367 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cisplatin, Gemcitabine Hydrochloride and Lymphadenectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
367 sitesUnited States
Study dates
24 Feb 2021to 30 Jun 2029
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 have the ability to understand and the willingness to sign a written informed consent document
  • Leukocytes >= 3,000/mcL (obtained =< 28 days prior to randomization)
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  • 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

Who cannot join

  • 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

Trial locations and contacts

367 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

  • Albany Medical Center

    Albany, New York, 12208

  • Lovelace Medical Center-Saint Joseph Square

    Albuquerque, New Mexico, 87102

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Presbyterian Kaseman Hospital

    Albuquerque, New Mexico, 87110

  • Saint Anthony's Health

    Alton, Illinois, 62002

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, 99504

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Mission Cancer and Blood - Ankeny

    Ankeny, Iowa, 50023

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Mission Hope Medical Oncology - Arroyo Grande

    Arroyo Grande, California, 93420

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • UM Sylvester Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

  • Saint Louis Cancer and Breast Institute-Ballwin

    Ballwin, Missouri, 63011

  • Flaget Memorial Hospital

    Bardstown, Kentucky, 40004

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Indu and Raj Soin Medical Center

    Beavercreek, Ohio, 45431

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Saint Charles Health System

    Bend, Oregon, 97701

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Saint Elizabeth Boardman Hospital

    Boardman, Ohio, 44512

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

  • Northeast Georgia Medical Center Braselton

    Braselton, Georgia, 30517

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310

  • United Hospital Center

    Bridgeport, West Virginia, 26330

  • University of Michigan - Brighton Center for Specialty Care

    Brighton, Michigan, 48116

  • Saint Joseph Regional Cancer Center

    Bryan, Texas, 77802

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Highline Medical Center-Main Campus

    Burien, Washington, 98166

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • Mercy Cancer Center - Carmichael

    Carmichael, California, 95608

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Saint Anthony Regional Hospital

    Carroll, Iowa, 51401

  • SIH Cancer Institute

    Carterville, Illinois, 62918

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Duke Cancer Institute Cary

    Cary, North Carolina, 27518

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Saint Mary's Hospital

    Centralia, Illinois, 62801

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • Roper Hospital

    Charleston, South Carolina, 29401

  • Charleston Oncology - Roper

    Charleston, South Carolina, 29403

  • Bon Secours Saint Francis Hospital

    Charleston, South Carolina, 29414

  • Charleston Oncology - Saint Francis

    Charleston, South Carolina, 29414

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Oncology Hematology Care Inc-Kenwood

    Cincinnati, Ohio, 45236

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • Mission Cancer and Blood - West Des Moines

    Clive, Iowa, 50325

  • Baptist Memorial Hospital and Cancer Center-Collierville

    Collierville, Tennessee, 38017

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

  • Saint Francis Cancer Center

    Colorado Springs, Colorado, 80923

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

  • Commonwealth Cancer Center-Corbin

    Corbin, Kentucky, 40701

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Premier Blood and Cancer Center

    Dayton, Ohio, 45409

  • Dayton Physician LLC - Englewood

    Dayton, Ohio, 45415

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Mission Cancer and Blood - Des Moines

    Des Moines, Iowa, 50309

  • Broadlawns Medical Center

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Mission Cancer and Blood - Laurel

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

  • Mercy Medical Center

    Durango, Colorado, 81301

  • Southwest Oncology PC

    Durango, Colorado, 81301

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Memorial Sloan Kettering Westchester

    East White Plains, New York, 10604

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Trinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus

    Elizabeth, New Jersey, 07207

  • Mercy Cancer Center - Elk Grove

    Elk Grove, California, 95758

  • Elmhurst Memorial Hospital

    Elmhurst, Illinois, 60126

  • Saint Elizabeth Hospital

    Enumclaw, Washington, 98022

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Sanford South University Medical Center

    Fargo, North Dakota, 58103

  • Southpointe-Sanford Medical Center Fargo

    Fargo, North Dakota, 58103

  • Sanford Medical Center Fargo

    Fargo, North Dakota, 58104

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • Armes Family Cancer Center

    Findlay, Ohio, 45840

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Orion Cancer Care

    Findlay, Ohio, 45840

  • Trinity Regional Medical Center

    Fort Dodge, Iowa, 50501

  • Regional Cancer Center-Lee Memorial Health System

    Fort Myers, Florida, 33905

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Dayton Physicians LLC-Atrium

    Franklin, Ohio, 45005

  • Vanderbilt-Ingram Cancer Center at Franklin

    Franklin, Tennessee, 37067

  • Vanderbilt-Ingram Cancer Center Cool Springs

    Franklin, Tennessee, 37067

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

  • University of Florida Health Science Center - Gainesville

    Gainesville, Florida, 32610

  • Northeast Georgia Medical Center-Gainesville

    Gainesville, Georgia, 30501

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Central Care Cancer Center - Garden City

    Garden City, Kansas, 67846

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • Nebraska Cancer Specialists/Oncology Hematology West PC

    Grand Island, Nebraska, 68803

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

  • Central Care Cancer Center - Great Bend

    Great Bend, Kansas, 67530

  • East Carolina University

    Greenville, North Carolina, 27834

  • Dayton Physicians LLC-Wayne

    Greenville, Ohio, 45331

  • Miami Valley Cancer Care and Infusion

    Greenville, Ohio, 45331

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Baptist Cancer Center-Grenada

    Grenada, Mississippi, 38901

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • The Cancer Institute of New Jersey Hamilton

    Hamilton, New Jersey, 08690

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • CHI Saint Vincent Cancer Center Hot Springs

    Hot Springs, Arkansas, 71913

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

  • MU Health Care Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • Jersey City Medical Center

    Jersey City, New Jersey, 07302

  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

    Jonesboro, Arkansas, 72401

  • Freeman Health System

    Joplin, Missouri, 64804

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Ascension Borgess Cancer Center

    Kalamazoo, Michigan, 49009

  • Borgess Medical Center

    Kalamazoo, Michigan, 49048

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • University of Tennessee - Knoxville

    Knoxville, Tennessee, 37920

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Providence Regional Cancer System-Lacey

    Lacey, Washington, 98503

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

  • Saint Anthony Hospital

    Lakewood, Colorado, 80228

  • Monmouth Medical Center Southern Campus

    Lakewood, New Jersey, 08701

  • Saint Clare Hospital

    Lakewood, Washington, 98499

  • Saint Joseph Hospital

    Lexington, Kentucky, 40504

  • Saint Joseph Radiation Oncology Resource Center

    Lexington, Kentucky, 40504

  • Saint Joseph Hospital East

    Lexington, Kentucky, 40509

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • Saint Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510

  • CARTI Cancer Center

    Little Rock, Arkansas, 72205

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Littleton Adventist Hospital

    Littleton, Colorado, 80122

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Saint Joseph London

    London, Kentucky, 40741

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • Rocky Mountain Cancer Centers-Longmont

    Longmont, Colorado, 80501

  • PeaceHealth Saint John Medical Center

    Longview, Washington, 98632

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Jewish Hospital

    Louisville, Kentucky, 40202

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • Saints Mary and Elizabeth Hospital

    Louisville, Kentucky, 40215

  • UofL Health Medical Center Northeast

    Louisville, Kentucky, 40245

  • Lowell General Hospital

    Lowell, Massachusetts, 01854

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • WVUH-Berkely Medical Center

    Martinsburg, West Virginia, 25401

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • UM Sylvester Comprehensive Cancer Center at Kendall

    Miami, Florida, 33176

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin, 54548

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

  • Saint Joseph Mount Sterling

    Mount Sterling, Kentucky, 40353

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Trinity Health Muskegon Hospital

    Muskegon, Michigan, 49444

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83686

  • Providence Queen of The Valley

    Napa, California, 94558

  • Edward Hospital/Cancer Center

    Naperville, Illinois, 60540

  • Vanderbilt Breast Center at One Hundred Oaks

    Nashville, Tennessee, 37204

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Baptist Memorial Hospital and Cancer Center-Union County

    New Albany, Mississippi, 38652

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • UC Comprehensive Cancer Center at Silver Cross

    New Lenox, Illinois, 60451

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07101

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

  • Corewell Health Lakeland Hospitals - Niles Hospital

    Niles, Michigan, 49120

  • Cancer and Hematology Centers of Western Michigan - Norton Shores

    Norton Shores, Michigan, 49444

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

  • HSHS Saint Elizabeth's Hospital

    O'Fallon, Illinois, 62269

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

  • Alegent Health Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Alegent Health Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Alegent Health Lakeside Hospital

    Omaha, Nebraska, 68130

  • Creighton University Medical Center

    Omaha, Nebraska, 68131

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Providence Willamette Falls Medical Center

    Oregon City, Oregon, 97045

  • University of Chicago Medicine-Orland Park

    Orland Park, Illinois, 60462

  • Lake Regional Hospital

    Osage Beach, Missouri, 65065

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Baptist Memorial Hospital and Cancer Center-Oxford

    Oxford, Mississippi, 38655

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304

  • Midlands Community Hospital

    Papillion, Nebraska, 68046

  • Parker Adventist Hospital

    Parker, Colorado, 80138

  • Camden Clark Medical Center

    Parkersburg, West Virginia, 26101

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • OSF Saint Francis Radiation Oncology at Pekin

    Pekin, Illinois, 61554

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Valley Radiation Oncology

    Peru, Illinois, 61354

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Cancer Center at Saint Joseph's

    Phoenix, Arizona, 85004

  • Edward Hospital/Cancer Center?Plainfield

    Plainfield, Illinois, 60585

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Harrison HealthPartners Hematology and Oncology-Poulsbo

    Poulsbo, Washington, 98370

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Saint Mary Corwin Medical Center

    Pueblo, Colorado, 81004

  • Duke Raleigh Hospital

    Raleigh, North Carolina, 27609

  • Saint Charles Health System-Redmond

    Redmond, Oregon, 97756

  • Corewell Health Reed City Hospital

    Reed City, Michigan, 49677

  • Queens Cancer Center

    Rego Park, New York, 11374

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

  • UT Southwestern Clinical Center at Richardson/Plano

    Richardson, Texas, 75080

  • Reid Health

    Richmond, Indiana, 47374

  • Presbyterian Rust Medical Center/Jorgensen Cancer Center

    Rio Rancho, New Mexico, 87124

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Highland Hospital

    Rochester, New York, 14620

  • University of Rochester

    Rochester, New York, 14642

  • Mercy Cancer Center - Rocklin

    Rocklin, California, 95765

  • Delbert Day Cancer Institute at PCRMC

    Rolla, Missouri, 65401

  • Mercy Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri, 65401

  • Mercy Cancer Center - Sacramento

    Sacramento, California, 95816

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • Corewell Health Lakeland Hospitals - Saint Joseph Hospital

    Saint Joseph, Michigan, 49085

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Pacific Central Coast Health Center-San Luis Obispo

    San Luis Obispo, California, 93401

  • Mission Hope Medical Oncology - Santa Maria

    Santa Maria, California, 93444

  • Providence Medical Foundation - Santa Rosa

    Santa Rosa, California, 95403

Other trials in United States

About this study

Official title: Optimal Perioperative Therapy for Incidental Gallbladder Cancer (OPT-IN): A Randomized Phase II/III Trial

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

Being tested
Cisplatin, Gemcitabine Hydrochloride, Lymphadenectomy, Partial Hepatectomy
Medical subject headings
Gallbladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • Gemcitabine HydrochlorideDrug

    Also called dFdCyd, Difluorodeoxycytidine Hydrochloride, FF 10832, FF-10832

    Given IV

  • LymphadenectomyProcedure or surgery

    Also called excision of the lymph node, Lymph Node Dissection, lymph node excision

    Undergo portal lymphadenectomy

  • Partial HepatectomyProcedure or surgery

    Also called partial excision of liver, subtotal hepatectomy

    Undergo partial hepatectomy

Study groups in NCT04559139
Study groupRoleWhat they receive
Arm I (surgery, adjuvant therapy)Active comparatorWithin 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 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.
Receives: Drug: Cisplatin; Drug: Gemcitabine Hydrochloride; Procedure: Lymphadenectomy; Procedure: Partial Hepatectomy
Arm II (neoadjuvant therapy, surgery, adjuvant therapy)ExperimentalPatients 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), then 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.
Receives: Drug: Cisplatin; Drug: Gemcitabine Hydrochloride; Procedure: Lymphadenectomy; Procedure: Partial Hepatectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in overall survival

    Will compare patients with incidental gallbladder cancer (IGBC) who receive perioperative chemotherapy prior to and after re-resection with patients who receive only adjuvant chemotherapy after re-resection. Will be evaluated by stratified log rank test, and Kaplan-Meier analyses will be used to calculate and display the overall survival distributions among all randomized patients on the two study arms (intention-to-treat analysis).

    Measured: Time from randomization to death or last follow-up, assessed up to 5 years

Secondary outcomes (5)

  1. Incidence of residual disease

    Will compare the incidence of residual disease which is defined as the presence of either microscopic or gross malignancy based on pathologic analysis of the re-resection specimen 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. Residual disease is defined as the presence of either microscopic or gross malignancy based on pathologic analysis of the re-resection specimen.

    Measured: At the time of re-resection, through study completion, an average of 5 years.

  2. Overall resectability rate

    Will be defined as the proportion of patients who successfully undergo a re-resection versus all enrolled patients. Descriptive statistics will be performed to calculate the number, proportion of patients, and 95% confidence intervals for the resectability and residual disease outcomes. Patients who do not undergo reoperation or re-resection, have incomplete resections (R2), or who have gross evidence of distant metastases and/or T4 disease will be considered as unresectable for resectability analyses.

    Measured: Up to 5 years

  3. Resectability rate

    Will be defined as the proportion of patients who successfully undergo a re-resection versus all patients who undergo screening laparoscopy. Descriptive statistics will be performed to calculate the number, proportion of patients, and 95% confidence intervals for the resectability and residual disease outcomes. Patients who do not undergo reoperation or re-resection, have incomplete resections (R2), or who have gross evidence of distant metastases and/or T4 disease will be considered as unresectable for resectability analyses.

    Measured: At the time of diagnostic laparoscopy, through study completion, an average of 5 years.

  4. Resectability rate

    Will be defined as the proportion of patients who successfully undergo a re-resection versus all patients who undergo laparotomy. Descriptive statistics will be performed to calculate the number, proportion of patients, and 95% confidence intervals for the resectability and residual disease outcomes. Patients who do not undergo reoperation or re-resection, have incomplete resections (R2), or who have gross evidence of distant metastases and/or T4 disease will be considered as unresectable for resectability analyses.

    Measured: At the time of laparotomy, through study completion, an average of 5 years.

  5. Difference in progression-free survival

    Will compare patients given neoadjuvant gemcitabine and cisplatin with patients who receive only adjuvant gemcitabine and cisplatin after re-resection for IGCB. A stratified log rank test, along with Kaplan-Meier curves, will be used to analyze progression-free survival among all evaluable patients.

    Measured: From randomization to first observed radiographic disease progression that is inoperable (either locoregional or distant metastatic), or death from any cause, assessed up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2020
  2. Study start24 Feb 2021
  3. Primary completion1 Jul 2028 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
186 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04559139
Sponsor's protocol ID
EA2197
Other IDs
NCI-2020-05162, EA2197, EA2197, U10CA180820
Status last verified
Oct 2026
First submitted
2 Sep 2020
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Cisplatin, Gemcitabine Hydrochloride and Lymphadenectomy in people with Stage II Gallbladder Cancer AJCC v8 and Stage IIA Gallbladder Cancer AJCC v8, run by ECOG-ACRIN Cancer Research Group at 367 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 367 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in overall survival (time frame: Time from randomization to death or last follow-up, assessed up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04559139.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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