ACTIVE_NOT_RECRUITING

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

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Conditions

Stage II Gallbladder Cancer AJCC v8Stage IIA Gallbladder Cancer AJCC v8Stage IIB Gallbladder Cancer AJCC v8Stage III Gallbladder Cancer AJCC v8Stage IIIA Gallbladder Cancer AJCC v8Stage IIIB Gallbladder Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-02-24
Study Completion:2029-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04559139

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  2. * Patient must have histologically-confirmed T2 or T3 gallbladder cancer discovered incidentally at the time of or following routine cholecystectomy for presumed benign disease
  3. * NOTE: Patients with histologically-confirmed Tis, T1a, T1b, or T4 tumors are not eligible
  4. * Patient must have undergone initial cholecystectomy within 12 weeks prior to randomization
  5. * Patient must have the ability to understand and the willingness to sign a written informed consent document
  6. * Leukocytes \>= 3,000/mcL (obtained =\< 28 days prior to randomization)
  7. * Absolute neutrophil count \>= 1,500/mcL (obtained =\< 28 days prior to randomization)
  8. * Platelets \>= 100,000/mcL (obtained =\< 28 days prior to randomization)
  9. * 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)
  10. * 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)
  11. * 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)
  12. * 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
  13. * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  14. * 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
  15. * 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
  16. * 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
  1. * 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
  2. * No radiographic evidence of distant disease (M1 disease)
  3. * No radiographic evidence of tumor invasion into multiple extrahepatic organs (T4 disease)
  4. * No radiographic evidence of distant lymph node involvement (celiac, para-aortic, para-caval lymph nodes)
  5. * No evidence of new-onset ascites
  6. * 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
  7. * 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)
  8. * 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

Contacts and Locations

Principal Investigator

Shishir K Maithel
PRINCIPAL_INVESTIGATOR
ECOG-ACRIN Cancer Research Group

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: ECOG-ACRIN Cancer Research Group

  • Shishir K Maithel, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2021-02-24
Study Completion Date2029-06-30

Study Record Updates

Study Start Date2021-02-24
Study Completion Date2029-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Stage II Gallbladder Cancer AJCC v8
  • Stage IIA Gallbladder Cancer AJCC v8
  • Stage IIB Gallbladder Cancer AJCC v8
  • Stage III Gallbladder Cancer AJCC v8
  • Stage IIIA Gallbladder Cancer AJCC v8
  • Stage IIIB Gallbladder Cancer AJCC v8