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Comparison of Chemotherapy before and after Surgery versus after Surgery Alone for the Treatment of Gallbladder Cancer, OPT-IN Trial

Trial Status: Active

This phase II / III trial compares the effect of adding chemotherapy before and after surgery versus after surgery alone (usual treatment) in treating patients with stage II-III gallbladder cancer. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before surgery may make the tumor smaller; therefore, may reduce the extent of surgery. Additionally, it may make it easier for the surgeon to distinguish between normal and cancerous tissue. Giving chemotherapy after surgery may kill any remaining tumor cells. This study will determine whether giving chemotherapy before surgery increases the length of time before the cancer may return and whether it will increase a patient’s life span compared to the usual approach.

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 or, have legally authorized representative provide authorization to participate
  • Leukocytes >= 3,000/mcL (obtained =< 28 days prior to randomization)
  • Absolute neutrophil count >= 1,500/mcL (obtained =< 28 days prior to randomization)
  • Platelets >= 100,000/mcL (obtained =< 28 days prior to randomization)
  • Total bilirubin =< institutional upper limit of normal (ULN) except in patients with Gilbert’s syndrome. Patients with Gilbert’s syndrome are eligible if direct bilirubin < 1.5 x ULN of the direct bilirubin (obtained =< 28 days prior to randomization)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained =< 28 days prior to randomization)
  • Serum creatinine =< institutional ULN OR creatinine clearance >= 50 mL/min/1.73 m^2 (Based on Cockcroft Gault estimation) (obtained =< 28 days prior to randomization)
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients should be class 2B or better

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

Alaska

Anchorage
Alaska Breast Care and Surgery LLC
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Alaska Oncology and Hematology LLC
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Alaska Women's Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Associates in Radiation Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Oncology Centre
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Radiation Therapy Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Katmai Oncology Group
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Providence Alaska Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871

Arizona

Phoenix
Cancer Center at Saint Joseph's
Status: ACTIVE
Contact: Site Public Contact
Phone: 602-406-8222

Arkansas

Ft. Smith
Mercy Hospital Fort Smith
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-378-9373
Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

California

Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
Status: ACTIVE
Contact: Site Public Contact
Phone: 916-851-2283
Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 818-847-4793
Los Angeles
Cedars Sinai Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 310-423-8965
San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
Status: ACTIVE
Contact: Site Public Contact
Santa Maria
Mission Hope Medical Oncology - Santa Maria
Status: ACTIVE
Contact: Site Public Contact
Phone: 916-851-2283

Colorado

Colorado Springs
Penrose-Saint Francis Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Rocky Mountain Cancer Centers-Penrose
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Denver
Porter Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Durango
Mercy Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Southwest Oncology PC
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Lakewood
Saint Anthony Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Littleton
Littleton Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Longmont
Longmont United Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Rocky Mountain Cancer Centers-Longmont
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Parker
Parker Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Pueblo
Saint Mary Corwin Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

Georgia

Atlanta
Emory Saint Joseph's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-851-7115
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-778-1868
Emory University Hospital Midtown
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-946-7447
Savannah
Memorial Health University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 912-350-7887
Summit Cancer Care-Memorial
Status: ACTIVE
Contact: Site Public Contact
Phone: 912-350-7887

Idaho

Boise
Saint Luke's Cancer Institute - Boise
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774
Fruitland
Saint Luke's Cancer Institute - Fruitland
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774
Meridian
Saint Luke's Cancer Institute - Meridian
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774
Nampa
Saint Luke's Cancer Institute - Nampa
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774
Twin Falls
Saint Luke's Cancer Institute - Twin Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774

Illinois

Bloomington
Illinois CancerCare-Bloomington
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Canton
Illinois CancerCare-Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Carbondale
Memorial Hospital of Carbondale
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-457-5200
Carterville
SIH Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-985-3333
Carthage
Illinois CancerCare-Carthage
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Centralia
Centralia Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Chicago
Northwestern University
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-695-1301
University of Chicago Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-8222
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Dixon
Illinois CancerCare-Dixon
Status: ACTIVE
Contact: Site Public Contact
Phone: 815-285-7800
Effingham
Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Eureka
Illinois CancerCare-Eureka
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Galesburg
Illinois CancerCare-Galesburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Western Illinois Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-344-2831
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Macomb
Illinois CancerCare-Macomb
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Mount Vernon
Good Samaritan Regional Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-242-4600
New Lenox
UC Comprehensive Cancer Center at Silver Cross
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-8222
O'Fallon
Cancer Care Center of O'Fallon
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Orland Park
University of Chicago Medicine-Orland Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-8222
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Pekin
Illinois CancerCare-Pekin
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Peoria
Illinois CancerCare-Peoria
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Methodist Medical Center of Illinois
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
OSF Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Peru
Illinois CancerCare-Peru
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Valley Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 815-664-4141
Princeton
Illinois CancerCare-Princeton
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Springfield
Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-788-3528
Southern Illinois University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-545-7929
Springfield Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-444-7541

Iowa

Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Mercy Cancer Center-West Lakes
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Council Bluffs
Alegent Health Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Creston
Greater Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Des Moines
Medical Oncology and Hematology Associates-Laurel
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Mercy Medical Center - Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
West Des Moines
Mercy Medical Center-West Lakes
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

Kansas

Garden City
Central Care Cancer Center - Garden City
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-948-5588
Great Bend
Central Care Cancer Center - Great Bend
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-948-5588

Kentucky

Bardstown
Flaget Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Corbin
Commonwealth Cancer Center-Corbin
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Lexington
Saint Joseph Hospital East
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Saint Joseph Radiation Oncology Resource Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
London
Saint Joseph London
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Louisville
Jewish Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Jewish Hospital Medical Center Northeast
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Saints Mary and Elizabeth Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
The James Graham Brown Cancer Center at University of Louisville
Status: ACTIVE
Contact: Site Public Contact
Phone: 502-562-3429
Shepherdsville
Jewish Hospital Medical Center South
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

Michigan

Battle Creek
Bronson Battle Creek
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Mercy Health Saint Mary's
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Spectrum Health at Butterworth Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Kalamazoo
Borgess Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Bronson Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
West Michigan Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Muskegon
Mercy Health Mercy Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Niles
Lakeland Hospital Niles
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Norton Shores
Cancer and Hematology Centers of Western Michigan - Norton Shores
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Reed City
Spectrum Health Reed City Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Saint Joseph
Lakeland Medical Center Saint Joseph
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Marie Yeager Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Traverse City
Munson Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Wyoming
Metro Health Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230

Minnesota

Bemidji
Sanford Joe Lueken Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-333-5000
Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Thief River Falls
Sanford Thief River Falls Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320
Worthington
Sanford Cancer Center Worthington
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320

Missouri

Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7058
Bolivar
Central Care Cancer Center - Bolivar
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-948-5588
Cape Girardeau
Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Southeast Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-651-5550
Creve Coeur
Siteman Cancer Center at West County Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Farmington
Parkland Health Center - Farmington
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Jefferson City
Capital Region Southwest Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-632-4814
Joplin
Freeman Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-347-4030
Mercy Hospital Joplin
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-556-3074
Rolla
Delbert Day Cancer Institute at PCRMC
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-458-8776
Mercy Clinic-Rolla-Cancer and Hematology
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-458-6379
Saint Joseph
Heartland Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 816-271-7937
Saint Louis
Mercy Hospital Saint Louis
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7066
Mercy Hospital South
Status: ACTIVE
Contact: Site Public Contact
Missouri Baptist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Saint Louis Cancer and Breast Institute-South City
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-353-1870
Siteman Cancer Center at Christian Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Siteman Cancer Center-South County
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Washington University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Springfield
CoxHealth South Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Mercy Hospital Springfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Sullivan
Missouri Baptist Sullivan Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Washington
Mercy Hospital Washington
Status: ACTIVE
Contact: Site Public Contact
Phone: 636-390-1600

Montana

Missoula
Saint Patrick Hospital - Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-327-3118

Nebraska

Grand Island
CHI Health Saint Francis
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Kearney
CHI Health Good Samaritan
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Lincoln
Saint Elizabeth Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Omaha
Alegent Health Bergan Mercy Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Alegent Health Immanuel Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Alegent Health Lakeside Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Creighton University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Papillion
Midlands Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

New Mexico

Albuquerque
Lovelace Medical Center-Saint Joseph Square
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-272-0530
Presbyterian Kaseman Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-559-6113
University of New Mexico Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-925-0366
Rio Rancho
Presbyterian Rust Medical Center / Jorgensen Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-559-6113

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Rochester
Highland Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-341-8113
University of Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-275-5830

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE
Contact: Site Public Contact
Phone: 336-713-6771

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-323-5760
Fargo
Sanford Broadway Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-323-5760
Sanford Medical Center Fargo
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-437-4010
Sanford Roger Maris Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-234-6161
Sanford South University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-234-6161
Southpointe-Sanford Medical Center Fargo
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320

Ohio

Cincinnati
Bethesda North Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Good Samaritan Hospital - Cincinnati
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
TriHealth Cancer Institute-Anderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
TriHealth Cancer Institute-Westside
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

Oklahoma

Oklahoma City
Mercy Hospital Oklahoma City
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-752-3402

Oregon

Bend
Saint Charles Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 541-706-2909
Clackamas
Clackamas Radiation Oncology Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Providence Cancer Institute Clackamas Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Coos Bay
Bay Area Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 541-269-8392
Newberg
Providence Newberg Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Portland
Oregon Health and Science University
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-494-1080
Providence Portland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Providence Saint Vincent Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Redmond
Saint Charles Health System-Redmond
Status: ACTIVE
Contact: Site Public Contact
Phone: 541-706-2909

South Dakota

Sioux Falls
Sanford Cancer Center Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320
Sanford USD Medical Center - Sioux Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320

Texas

Bryan
Saint Joseph Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

Washington

Aberdeen
Providence Regional Cancer System-Aberdeen
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958
Bellingham
PeaceHealth Saint Joseph Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-788-8238
Bremerton
Harrison HealthPartners Hematology and Oncology-Bremerton
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Harrison Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Burien
Highline Medical Center-Main Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Centralia
Providence Regional Cancer System-Centralia
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958
Edmonds
Swedish Cancer Institute-Edmonds
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Enumclaw
Saint Elizabeth Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Everett
Providence Regional Cancer Partnership
Status: ACTIVE
Contact: Site Public Contact
Phone: 425-261-3529
Federal Way
Saint Francis Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Issaquah
Swedish Cancer Institute-Issaquah
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Kennewick
Kadlec Clinic Hematology and Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 509-783-4637
Lacey
Providence Regional Cancer System-Lacey
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958
Lakewood
Saint Clare Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Longview
PeaceHealth Saint John Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-514-2016
Poulsbo
Harrison HealthPartners Hematology and Oncology-Poulsbo
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Seattle
Pacific Gynecology Specialists
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-Ballard Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-Cherry Hill
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-First Hill
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Sedro-Woolley
PeaceHealth United General Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-788-8238
Shelton
Providence Regional Cancer System-Shelton
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958
Tacoma
Franciscan Research Center-Northwest Medical Plaza
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Northwest Medical Specialties PLLC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-306-0532
Vancouver
PeaceHealth Southwest Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-514-3940
Walla Walla
Providence Saint Mary Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 509-897-5993
Yelm
Providence Regional Cancer System-Yelm
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958

West Virginia

Bridgeport
United Hospital Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 304-293-7374
Martinsburg
WVUH-Berkely Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 304-293-7374
Morgantown
West Virginia University Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 304-293-7374
Parkersburg
Camden Clark Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 304-293-7374

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.

Trial Phase Phase II/III

Trial Type Treatment

Lead Organization
ECOG-ACRIN Cancer Research Group

Principal Investigator
Shishir Kumar Maithel

  • Primary ID EA2197
  • Secondary IDs NCI-2020-05162
  • Clinicaltrials.gov ID NCT04559139