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

April 29, 2026 updated by: ECOG-ACRIN Cancer Research Group

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

186

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham Cancer Center
    • Alaska
      • Anchorage, Alaska, United States, 98508
        • Anchorage Associates in Radiation Medicine
      • Anchorage, Alaska, United States, 99508
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, United States, 99508
        • Alaska Oncology and Hematology LLC
      • Anchorage, Alaska, United States, 99508
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, United States, 99508
        • Anchorage Oncology Centre
      • Anchorage, Alaska, United States, 99508
        • Katmai Oncology Group
      • Anchorage, Alaska, United States, 99508
        • Providence Alaska Medical Center
      • Anchorage, Alaska, United States, 99504
        • Anchorage Radiation Therapy Center
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Cancer Center at Saint Joseph's
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Mercy Hospital Fort Smith
      • Hot Springs, Arkansas, United States, 71913
        • CHI Saint Vincent Cancer Center Hot Springs
      • Jonesboro, Arkansas, United States, 72401
        • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, United States, 72205
        • CARTI Cancer Center
    • California
      • Arroyo Grande, California, United States, 93420
        • Mission Hope Medical Oncology - Arroyo Grande
      • Burbank, California, United States, 91505
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Carmichael, California, United States, 95608
        • Mercy San Juan Medical Center
      • Carmichael, California, United States, 95608
        • Mercy Cancer Center - Carmichael
      • Elk Grove, California, United States, 95758
        • Mercy Cancer Center - Elk Grove
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Napa, California, United States, 94558
        • Providence Queen of The Valley
      • Orange, California, United States, 92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Palo Alto, California, United States, 94304
        • Stanford Cancer Institute Palo Alto
      • Rocklin, California, United States, 95765
        • Mercy Cancer Center - Rocklin
      • Sacramento, California, United States, 95817
        • University of California Davis Comprehensive Cancer Center
      • Sacramento, California, United States, 95816
        • Mercy Cancer Center - Sacramento
      • San Luis Obispo, California, United States, 93401
        • Pacific Central Coast Health Center-San Luis Obispo
      • Santa Maria, California, United States, 93444
        • Mission Hope Medical Oncology - Santa Maria
      • Santa Rosa, California, United States, 95403
        • Providence Medical Foundation - Santa Rosa
      • Santa Rosa, California, United States, 95405
        • Providence Santa Rosa Memorial Hospital
      • Torrance, California, United States, 90509
        • Torrance Memorial Medical Center
      • Torrance, California, United States, 90505
        • Torrance Memorial Physician Network - Cancer Care
      • Woodland, California, United States, 95695
        • Woodland Memorial Hospital
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Penrose-Saint Francis Healthcare
      • Colorado Springs, Colorado, United States, 80907
        • Rocky Mountain Cancer Centers-Penrose
      • Colorado Springs, Colorado, United States, 80923
        • Saint Francis Cancer Center
      • Denver, Colorado, United States, 80210
        • Porter Adventist Hospital
      • Durango, Colorado, United States, 81301
        • Mercy Medical Center
      • Durango, Colorado, United States, 81301
        • Southwest Oncology PC
      • Lakewood, Colorado, United States, 80228
        • Saint Anthony Hospital
      • Littleton, Colorado, United States, 80122
        • Littleton Adventist Hospital
      • Longmont, Colorado, United States, 80501
        • Longmont United Hospital
      • Longmont, Colorado, United States, 80501
        • Rocky Mountain Cancer Centers-Longmont
      • Parker, Colorado, United States, 80138
        • Parker Adventist Hospital
      • Pueblo, Colorado, United States, 81004
        • Saint Mary Corwin Medical Center
    • Florida
      • Aventura, Florida, United States, 33180
        • UM Sylvester Comprehensive Cancer Center at Aventura
      • Coral Gables, Florida, United States, 33146
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
      • Deerfield Beach, Florida, United States, 33442
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
      • Fort Myers, Florida, United States, 33905
        • Regional Cancer Center-Lee Memorial Health System
      • Gainesville, Florida, United States, 32610
        • University of Florida Health Science Center - Gainesville
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
      • Miami, Florida, United States, 33176
        • UM Sylvester Comprehensive Cancer Center at Kendall
      • Plantation, Florida, United States, 33324
        • UM Sylvester Comprehensive Cancer Center at Plantation
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital/Winship Cancer Institute
      • Atlanta, Georgia, United States, 30342
        • Emory Saint Joseph's Hospital
      • Braselton, Georgia, United States, 30517
        • Northeast Georgia Medical Center Braselton
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center-Gainesville
      • Savannah, Georgia, United States, 31404
        • Memorial Health University Medical Center
      • Savannah, Georgia, United States, 31404
        • Summit Cancer Care-Memorial
      • Savannah, Georgia, United States, 31404
        • Low Country Cancer Care
    • Idaho
      • Boise, Idaho, United States, 83712
        • Saint Luke's Cancer Institute - Boise
      • Fruitland, Idaho, United States, 83619
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, United States, 83642
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, United States, 83686
        • Saint Luke's Cancer Institute - Nampa
      • Twin Falls, Idaho, United States, 83301
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Alton, Illinois, United States, 62002
        • Saint Anthony's Health
      • Aurora, Illinois, United States, 60504
        • Rush - Copley Medical Center
      • Bloomington, Illinois, United States, 61704
        • Illinois CancerCare-Bloomington
      • Canton, Illinois, United States, 61520
        • Illinois CancerCare-Canton
      • Carbondale, Illinois, United States, 62902
        • Memorial Hospital of Carbondale
      • Carterville, Illinois, United States, 62918
        • SIH Cancer Institute
      • Carthage, Illinois, United States, 62321
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, United States, 62801
        • Centralia Oncology Clinic
      • Centralia, Illinois, United States, 62801
        • Saint Mary's Hospital
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, United States, 60612
        • University of Illinois
      • Danville, Illinois, United States, 61832
        • Carle at The Riverfront
      • DeKalb, Illinois, United States, 60115
        • Northwestern Medicine Cancer Center Kishwaukee
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Dixon, Illinois, United States, 61021
        • Illinois CancerCare-Dixon
      • Effingham, Illinois, United States, 62401
        • Crossroads Cancer Center
      • Effingham, Illinois, United States, 62401
        • Carle Physician Group-Effingham
      • Elmhurst, Illinois, United States, 60126
        • Elmhurst Memorial Hospital
      • Eureka, Illinois, United States, 61530
        • Illinois CancerCare-Eureka
      • Galesburg, Illinois, United States, 61401
        • Western Illinois Cancer Treatment Center
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare-Galesburg
      • Geneva, Illinois, United States, 60134
        • Northwestern Medicine Cancer Center Delnor
      • Kewanee, Illinois, United States, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Macomb, Illinois, United States, 61455
        • Illinois CancerCare-Macomb
      • Mattoon, Illinois, United States, 61938
        • Carle Physician Group-Mattoon/Charleston
      • Mount Vernon, Illinois, United States, 62864
        • Good Samaritan Regional Health Center
      • Naperville, Illinois, United States, 60540
        • Edward Hospital/Cancer Center
      • New Lenox, Illinois, United States, 60451
        • UC Comprehensive Cancer Center at Silver Cross
      • O'Fallon, Illinois, United States, 62269
        • Cancer Care Center of O'Fallon
      • O'Fallon, Illinois, United States, 62269
        • HSHS Saint Elizabeth's Hospital
      • Orland Park, Illinois, United States, 60462
        • University of Chicago Medicine-Orland Park
      • Ottawa, Illinois, United States, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Pekin, Illinois, United States, 61554
        • Illinois CancerCare-Pekin
      • Pekin, Illinois, United States, 61554
        • OSF Saint Francis Radiation Oncology at Pekin
      • Peoria, Illinois, United States, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, United States, 61637
        • OSF Saint Francis Medical Center
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare-Peoria
      • Peoria, Illinois, United States, 61615
        • OSF Saint Francis Radiation Oncology at Peoria Cancer Center
      • Peru, Illinois, United States, 61354
        • Illinois CancerCare-Peru
      • Peru, Illinois, United States, 61354
        • Valley Radiation Oncology
      • Plainfield, Illinois, United States, 60585
        • Edward Hospital/Cancer Center?Plainfield
      • Princeton, Illinois, United States, 61356
        • Illinois CancerCare-Princeton
      • Springfield, Illinois, United States, 62781
        • Memorial Medical Center
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, United States, 62702
        • Springfield Clinic
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
      • Warrenville, Illinois, United States, 60555
        • Northwestern Medicine Cancer Center Warrenville
      • Washington, Illinois, United States, 61571
        • Illinois CancerCare - Washington
      • Yorkville, Illinois, United States, 60560
        • Rush-Copley Healthcare Center
    • Indiana
      • Richmond, Indiana, United States, 47374
        • Reid Health
    • Iowa
      • Ankeny, Iowa, United States, 50023
        • Mission Cancer and Blood - Ankeny
      • Carroll, Iowa, United States, 51401
        • Saint Anthony Regional Hospital
      • Clive, Iowa, United States, 50325
        • Mercy Cancer Center-West Lakes
      • Clive, Iowa, United States, 50325
        • Mission Cancer and Blood - West Des Moines
      • Council Bluffs, Iowa, United States, 51503
        • Alegent Health Mercy Hospital
      • Creston, Iowa, United States, 50801
        • Greater Regional Medical Center
      • Des Moines, Iowa, United States, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, United States, 50314
        • Broadlawns Medical Center
      • Des Moines, Iowa, United States, 50314
        • Mission Cancer and Blood - Laurel
      • Des Moines, Iowa, United States, 50316
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, United States, 50309
        • Mission Cancer and Blood - Des Moines
      • Fort Dodge, Iowa, United States, 50501
        • Trinity Regional Medical Center
      • West Des Moines, Iowa, United States, 50266-7700
        • Methodist West Hospital
      • West Des Moines, Iowa, United States, 50266
        • Mercy Medical Center-West Lakes
    • Kansas
      • Garden City, Kansas, United States, 67846
        • Central Care Cancer Center - Garden City
      • Great Bend, Kansas, United States, 67530
        • Central Care Cancer Center - Great Bend
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Flaget Memorial Hospital
      • Corbin, Kentucky, United States, 40701
        • Commonwealth Cancer Center-Corbin
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky/Markey Cancer Center
      • Lexington, Kentucky, United States, 40504
        • Saint Joseph Radiation Oncology Resource Center
      • Lexington, Kentucky, United States, 40509
        • Saint Joseph Hospital East
      • Lexington, Kentucky, United States, 40504
        • Saint Joseph Hospital
      • London, Kentucky, United States, 40741
        • Saint Joseph London
      • Louisville, Kentucky, United States, 40202
        • The James Graham Brown Cancer Center at University of Louisville
      • Louisville, Kentucky, United States, 40202
        • Jewish Hospital
      • Louisville, Kentucky, United States, 40245
        • UofL Health Medical Center Northeast
      • Louisville, Kentucky, United States, 40215
        • Saints Mary and Elizabeth Hospital
      • Mount Sterling, Kentucky, United States, 40353
        • Saint Joseph Mount Sterling
      • Shepherdsville, Kentucky, United States, 40165
        • Jewish Hospital Medical Center South
    • Massachusetts
      • Lowell, Massachusetts, United States, 01854
        • Lowell General Hospital
      • Worcester, Massachusetts, United States, 01655
        • UMass Memorial Medical Center - University Campus
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center
      • Battle Creek, Michigan, United States, 49017
        • Bronson Battle Creek
      • Brighton, Michigan, United States, 48116
        • University of Michigan - Brighton Center for Specialty Care
      • Grand Rapids, Michigan, United States, 49503
        • Trinity Health Grand Rapids Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, United States, 49048
        • Borgess Medical Center
      • Kalamazoo, Michigan, United States, 49009
        • Ascension Borgess Cancer Center
      • Muskegon, Michigan, United States, 49444
        • Trinity Health Muskegon Hospital
      • Niles, Michigan, United States, 49120
        • Corewell Health Lakeland Hospitals - Niles Hospital
      • Norton Shores, Michigan, United States, 49444
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
      • Reed City, Michigan, United States, 49677
        • Corewell Health Reed City Hospital
      • Saint Joseph, Michigan, United States, 49085
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
      • Saint Joseph, Michigan, United States, 49085
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
      • Wyoming, Michigan, United States, 49519
        • University of Michigan Health - West
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
        • Sanford Joe Lueken Cancer Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester
      • Thief River Falls, Minnesota, United States, 56701
        • Sanford Thief River Falls Medical Center
      • Worthington, Minnesota, United States, 56187
        • Sanford Cancer Center Worthington
    • Mississippi
      • Grenada, Mississippi, United States, 38901
        • Baptist Cancer Center-Grenada
      • New Albany, Mississippi, United States, 38652
        • Baptist Memorial Hospital and Cancer Center-Union County
      • Oxford, Mississippi, United States, 38655
        • Baptist Memorial Hospital and Cancer Center-Oxford
      • Southhaven, Mississippi, United States, 38671
        • Baptist Memorial Hospital and Cancer Center-Desoto
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Saint Louis Cancer and Breast Institute-Ballwin
      • Bolivar, Missouri, United States, 65613
        • Central Care Cancer Center - Bolivar
      • Branson, Missouri, United States, 65616
        • Cox Cancer Center Branson
      • Cape Girardeau, Missouri, United States, 63703
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, United States, 63703
        • Southeast Cancer Center
      • City of Saint Peters, Missouri, United States, 63376
        • Siteman Cancer Center at Saint Peters Hospital
      • Creve Coeur, Missouri, United States, 63141
        • Siteman Cancer Center at West County Hospital
      • Farmington, Missouri, United States, 63640
        • Parkland Health Center - Farmington
      • Jefferson City, Missouri, United States, 65109
        • MU Health Care Goldschmidt Cancer Center
      • Joplin, Missouri, United States, 64804
        • Freeman Health System
      • Joplin, Missouri, United States, 64804
        • Mercy Hospital Joplin
      • Osage Beach, Missouri, United States, 65065
        • Lake Regional Hospital
      • Rolla, Missouri, United States, 65401
        • Delbert Day Cancer Institute at PCRMC
      • Rolla, Missouri, United States, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Saint Joseph, Missouri, United States, 64506
        • Heartland Regional Medical Center
      • Sainte Genevieve, Missouri, United States, 63670
        • Sainte Genevieve County Memorial Hospital
      • Springfield, Missouri, United States, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, United States, 63129
        • Siteman Cancer Center-South County
      • St Louis, Missouri, United States, 63136
        • Siteman Cancer Center at Christian Hospital
      • St Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
      • St Louis, Missouri, United States, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, United States, 63128
        • Mercy Hospital South
      • St Louis, Missouri, United States, 63109
        • Saint Louis Cancer and Breast Institute-South City
      • Sullivan, Missouri, United States, 63080
        • Missouri Baptist Sullivan Hospital
      • Sunset Hills, Missouri, United States, 63127
        • BJC Outpatient Center at Sunset Hills
      • Washington, Missouri, United States, 63090
        • Mercy Hospital Washington
    • Montana
      • Missoula, Montana, United States, 59802
        • Saint Patrick Hospital - Community Hospital
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Nebraska Cancer Specialists/Oncology Hematology West PC
      • Kearney, Nebraska, United States, 68847
        • CHI Health Good Samaritan
      • Lincoln, Nebraska, United States, 68510
        • Saint Elizabeth Regional Medical Center
      • Omaha, Nebraska, United States, 68124
        • Alegent Health Bergan Mercy Medical Center
      • Omaha, Nebraska, United States, 68122
        • Alegent Health Immanuel Medical Center
      • Omaha, Nebraska, United States, 68130
        • Alegent Health Lakeside Hospital
      • Omaha, Nebraska, United States, 68131
        • Creighton University Medical Center
      • Papillion, Nebraska, United States, 68046
        • Midlands Community Hospital
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Basking Ridge
      • Elizabeth, New Jersey, United States, 07207
        • Trinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus
      • Hamilton, New Jersey, United States, 08690
        • The Cancer Institute of New Jersey Hamilton
      • Jersey City, New Jersey, United States, 07302
        • Jersey City Medical Center
      • Lakewood, New Jersey, United States, 08701
        • Monmouth Medical Center Southern Campus
      • Livingston, New Jersey, United States, 07039
        • Saint Barnabas Medical Center
      • Long Branch, New Jersey, United States, 07740
        • Monmouth Medical Center
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Bergen
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey
      • Newark, New Jersey, United States, 07101
        • Rutgers New Jersey Medical School
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
      • Somerville, New Jersey, United States, 08876
        • Robert Wood Johnson University Hospital Somerset
      • Toms River, New Jersey, United States, 08755
        • Community Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Lovelace Medical Center-Saint Joseph Square
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Cancer Center
      • Albuquerque, New Mexico, United States, 87110
        • Presbyterian Kaseman Hospital
      • Rio Rancho, New Mexico, United States, 87124
        • Presbyterian Rust Medical Center/Jorgensen Cancer Center
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Commack
      • East White Plains, New York, United States, 10604
        • Memorial Sloan Kettering Westchester
      • Lake Success, New York, United States, 11042
        • Northwell Health/Center for Advanced Medicine
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • Mineola, New York, United States, 11501
        • NYU Langone Hospital - Long Island
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • Rego Park, New York, United States, 11374
        • Queens Cancer Center
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Rochester, New York, United States, 14620
        • Highland Hospital
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Nassau
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Duke Cancer Institute Cary
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Greenville, North Carolina, United States, 27834
        • East Carolina University
      • Raleigh, North Carolina, United States, 27609
        • Duke Raleigh Hospital
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Sanford Bismarck Medical Center
      • Fargo, North Dakota, United States, 58122
        • Sanford Roger Maris Cancer Center
      • Fargo, North Dakota, United States, 58122
        • Sanford Broadway Medical Center
      • Fargo, North Dakota, United States, 58103
        • Sanford South University Medical Center
      • Fargo, North Dakota, United States, 58103
        • Southpointe-Sanford Medical Center Fargo
      • Fargo, North Dakota, United States, 58104
        • Sanford Medical Center Fargo
    • Ohio
      • Beavercreek, Ohio, United States, 45431
        • Indu and Raj Soin Medical Center
      • Boardman, Ohio, United States, 44512
        • Saint Elizabeth Boardman Hospital
      • Centerville, Ohio, United States, 45459
        • Miami Valley Hospital South
      • Centerville, Ohio, United States, 45459
        • Dayton Physicians LLC-Miami Valley South
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital - Cincinnati
      • Cincinnati, Ohio, United States, 45242
        • Bethesda North Hospital
      • Cincinnati, Ohio, United States, 45236
        • Oncology Hematology Care Inc-Kenwood
      • Cincinnati, Ohio, United States, 45247
        • TriHealth Cancer Institute-Westside
      • Cincinnati, Ohio, United States, 45255
        • TriHealth Cancer Institute-Anderson
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, United States, 45415
        • Miami Valley Hospital North
      • Dayton, Ohio, United States, 45415
        • Dayton Physician LLC - Englewood
      • Dayton, Ohio, United States, 45409
        • Premier Blood and Cancer Center
      • Findlay, Ohio, United States, 45840
        • Blanchard Valley Hospital
      • Findlay, Ohio, United States, 45840
        • Armes Family Cancer Center
      • Findlay, Ohio, United States, 45840
        • Orion Cancer Care
      • Franklin, Ohio, United States, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Franklin, Ohio, United States, 45005
        • Dayton Physicians LLC-Atrium
      • Greenville, Ohio, United States, 45331
        • Wayne Hospital
      • Greenville, Ohio, United States, 45331
        • Dayton Physicians LLC-Wayne
      • Greenville, Ohio, United States, 45331
        • Miami Valley Cancer Care and Infusion
      • Kettering, Ohio, United States, 45429
        • Kettering Medical Center
      • Kettering, Ohio, United States, 45409
        • Greater Dayton Cancer Center
      • Springfield, Ohio, United States, 45504
        • Springfield Regional Cancer Center
      • Springfield, Ohio, United States, 45504
        • Springfield Regional Medical Center
      • Troy, Ohio, United States, 45373
        • Upper Valley Medical Center
      • Troy, Ohio, United States, 45373
        • Dayton Physicians LLC - Troy
      • Warren, Ohio, United States, 44484
        • Saint Joseph Warren Hospital
      • Youngstown, Ohio, United States, 44501
        • Saint Elizabeth Youngstown Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Mercy Hospital Oklahoma City
    • Oregon
      • Bend, Oregon, United States, 97701
        • Saint Charles Health System
      • Clackamas, Oregon, United States, 97015
        • Clackamas Radiation Oncology Center
      • Clackamas, Oregon, United States, 97015
        • Providence Cancer Institute Clackamas Clinic
      • Coos Bay, Oregon, United States, 97420
        • Bay Area Hospital
      • Gresham, Oregon, United States, 97030
        • Legacy Mount Hood Medical Center
      • Newberg, Oregon, United States, 97132
        • Providence Newberg Medical Center
      • Oregon City, Oregon, United States, 97045
        • Providence Willamette Falls Medical Center
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
      • Portland, Oregon, United States, 97210
        • Legacy Good Samaritan Hospital and Medical Center
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • Providence Saint Vincent Medical Center
      • Redmond, Oregon, United States, 97756
        • Saint Charles Health System-Redmond
      • Tualatin, Oregon, United States, 97062
        • Legacy Meridian Park Hospital
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania/Abramson Cancer Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Charleston, South Carolina, United States, 29401
        • Roper Hospital
      • Charleston, South Carolina, United States, 29414
        • Bon Secours Saint Francis Hospital
      • Charleston, South Carolina, United States, 29403
        • Charleston Oncology - Roper
      • Charleston, South Carolina, United States, 29414
        • Charleston Oncology - Saint Francis
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center Oncology Clinic
    • Tennessee
      • Collierville, Tennessee, United States, 38017
        • Baptist Memorial Hospital and Cancer Center-Collierville
      • Franklin, Tennessee, United States, 37067
        • Vanderbilt-Ingram Cancer Center Cool Springs
      • Franklin, Tennessee, United States, 37067
        • Vanderbilt-Ingram Cancer Center at Franklin
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee - Knoxville
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital and Cancer Center-Memphis
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University/Ingram Cancer Center
      • Nashville, Tennessee, United States, 37204
        • Vanderbilt Breast Center at One Hundred Oaks
    • Texas
      • Bryan, Texas, United States, 77802
        • Saint Joseph Regional Cancer Center
      • Dallas, Texas, United States, 75235
        • Parkland Memorial Hospital
      • Dallas, Texas, United States, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Richardson, Texas, United States, 75080
        • UT Southwestern Clinical Center at Richardson/Plano
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
    • Washington
      • Aberdeen, Washington, United States, 98520
        • Providence Regional Cancer System-Aberdeen
      • Bellingham, Washington, United States, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Bremerton, Washington, United States, 98310
        • Harrison HealthPartners Hematology and Oncology-Bremerton
      • Burien, Washington, United States, 98166
        • Highline Medical Center-Main Campus
      • Centralia, Washington, United States, 98531
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, United States, 98026
        • Swedish Cancer Institute-Edmonds
      • Enumclaw, Washington, United States, 98022
        • Saint Elizabeth Hospital
      • Everett, Washington, United States, 98201
        • Providence Regional Cancer Partnership
      • Federal Way, Washington, United States, 98003
        • Saint Francis Hospital
      • Issaquah, Washington, United States, 98029
        • Swedish Cancer Institute-Issaquah
      • Kennewick, Washington, United States, 99336
        • Kadlec Clinic Hematology and Oncology
      • Lacey, Washington, United States, 98503
        • Providence Regional Cancer System-Lacey
      • Lakewood, Washington, United States, 98499
        • Saint Clare Hospital
      • Longview, Washington, United States, 98632
        • PeaceHealth Saint John Medical Center
      • Poulsbo, Washington, United States, 98370
        • Harrison HealthPartners Hematology and Oncology-Poulsbo
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Seattle, Washington, United States, 98107
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center-First Hill
      • Seattle, Washington, United States, 98104
        • Pacific Gynecology Specialists
      • Seattle, Washington, United States, 98122-5711
        • Swedish Medical Center-Cherry Hill
      • Sedro-Woolley, Washington, United States, 98284
        • PeaceHealth United General Medical Center
      • Shelton, Washington, United States, 98584
        • Providence Regional Cancer System-Shelton
      • Silverdale, Washington, United States, 98383
        • Saint Michael Cancer Center
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties PLLC
      • Tacoma, Washington, United States, 98405
        • Franciscan Research Center-Northwest Medical Plaza
      • Vancouver, Washington, United States, 98686
        • Legacy Salmon Creek Hospital
      • Vancouver, Washington, United States, 98664
        • PeaceHealth Southwest Medical Center
      • Vancouver, Washington, United States, 98684
        • Legacy Cancer Institute Medical Oncology and Day Treatment
      • Walla Walla, Washington, United States, 99362
        • Providence Saint Mary Regional Cancer Center
      • Yelm, Washington, United States, 98597
        • Providence Regional Cancer System-Yelm
    • West Virginia
      • Bridgeport, West Virginia, United States, 26330
        • United Hospital Center
      • Martinsburg, West Virginia, United States, 25401
        • WVUH-Berkely Medical Center
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Healthcare
      • Parkersburg, West Virginia, United States, 26101
        • Camden Clark Medical Center
    • Wisconsin
      • Eau Claire, Wisconsin, United States, 54701
        • Marshfield Medical Center-EC Cancer Center
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Medical Center
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Carbone Cancer Center - University Hospital
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Center-Marshfield
      • Minocqua, Wisconsin, United States, 54548
        • Marshfield Clinic-Minocqua Center
      • Rice Lake, Wisconsin, United States, 54868
        • Marshfield Medical Center-Rice Lake
      • Stevens Point, Wisconsin, United States, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Weston, Wisconsin, United States, 54476
        • Marshfield Medical Center - Weston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)
  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I (surgery, adjuvant therapy)
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 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.
Drug: Cisplatin
Given IV
Other Names:
  • CDDP
  • Cis-diamminedichloridoplatinum
  • Cismaplat
  • Cisplatinum
  • Neoplatin
  • Platinol
  • Abiplatin
  • Blastolem
  • Briplatin
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cisplatina
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
  • Peyrone''s Chloride
  • Peyrone''s Salt
Drug: Gemcitabine Hydrochloride
Given IV
Other Names:
  • Gemzar
  • dFdCyd
  • Difluorodeoxycytidine Hydrochloride
  • FF 10832
  • FF-10832
  • FF10832
  • Gemcitabine HCI
  • LY-188011
  • LY188011
Procedure: Lymphadenectomy
Undergo portal lymphadenectomy
Other Names:
  • excision of the lymph node
  • Lymph Node Dissection
  • lymph node excision
Procedure: Partial Hepatectomy
Undergo partial hepatectomy
Other Names:
  • partial excision of liver
  • subtotal hepatectomy
Experimental: Arm II (neoadjuvant therapy, surgery, adjuvant therapy)
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), 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.
Drug: Cisplatin
Given IV
Other Names:
  • CDDP
  • Cis-diamminedichloridoplatinum
  • Cismaplat
  • Cisplatinum
  • Neoplatin
  • Platinol
  • Abiplatin
  • Blastolem
  • Briplatin
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cisplatina
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
  • Peyrone''s Chloride
  • Peyrone''s Salt
Drug: Gemcitabine Hydrochloride
Given IV
Other Names:
  • Gemzar
  • dFdCyd
  • Difluorodeoxycytidine Hydrochloride
  • FF 10832
  • FF-10832
  • FF10832
  • Gemcitabine HCI
  • LY-188011
  • LY188011
Procedure: Lymphadenectomy
Undergo portal lymphadenectomy
Other Names:
  • excision of the lymph node
  • Lymph Node Dissection
  • lymph node excision
Procedure: Partial Hepatectomy
Undergo partial hepatectomy
Other Names:
  • partial excision of liver
  • subtotal hepatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in overall survival
Time Frame: Time from randomization to death or last follow-up, assessed up to 5 years
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).
Time from randomization to death or last follow-up, assessed up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of residual disease
Time Frame: At the time of re-resection, through study completion, an average of 5 years.
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.
At the time of re-resection, through study completion, an average of 5 years.
Overall resectability rate
Time Frame: Up to 5 years
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.
Up to 5 years
Resectability rate
Time Frame: At the time of diagnostic laparoscopy, through study completion, an average of 5 years.
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.
At the time of diagnostic laparoscopy, through study completion, an average of 5 years.
Resectability rate
Time Frame: At the time of laparotomy, through study completion, an average of 5 years.
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.
At the time of laparotomy, through study completion, an average of 5 years.
Difference in progression-free survival
Time Frame: 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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ECOG-ACRIN Cancer Research Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Shishir K Maithel, ECOG-ACRIN Cancer Research Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2021

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

September 2, 2020

First Submitted That Met QC Criteria

September 16, 2020

First Posted (Actual)

September 22, 2020

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA2197 (Other Identifier: CTEP)
  • U10CA180820 (U.S. NIH Grant/Contract)
  • NCI-2020-05162 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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