Comparison of Chemotherapy Before and After Surgery Versus After Surgery Alone for the Treatment of Gallbladder Cancer
Purpose
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.
Conditions
- 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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
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. |
|
Recruiting Locations
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
Birmingham, Alabama 35233
Anchorage Associates in Radiation Medicine
Anchorage, Alaska 98508
Anchorage, Alaska 98508
Anchorage Radiation Therapy Center
Anchorage, Alaska 99504
Anchorage, Alaska 99504
Alaska Breast Care and Surgery LLC
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Alaska Oncology and Hematology LLC
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Alaska Women's Cancer Care
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage Oncology Centre
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Katmai Oncology Group
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Providence Alaska Medical Center
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Cancer Center at Saint Joseph's
Phoenix, Arizona 85004
Phoenix, Arizona 85004
Mercy Hospital Fort Smith
Fort Smith, Arkansas 72903
Fort Smith, Arkansas 72903
Contact:
Site Public Contact
800-378-9373
Site Public Contact
800-378-9373
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas 72401
Jonesboro, Arkansas 72401
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274
Site Public Contact
501-686-8274
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California 93420
Arroyo Grande, California 93420
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California 91505
Burbank, California 91505
Mercy Cancer Center �� Carmichael
Carmichael, California 95608
Carmichael, California 95608
Mercy San Juan Medical Center
Carmichael, California 95608
Carmichael, California 95608
Mercy Cancer Center - Elk Grove
Elk Grove, California 95758
Elk Grove, California 95758
Cedars Sinai Medical Center
Los Angeles, California 90048
Los Angeles, California 90048
Contact:
Site Public Contact
310-423-8965
Site Public Contact
310-423-8965
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868
Orange, California 92868
Stanford Cancer Institute Palo Alto
Palo Alto, California 94304
Palo Alto, California 94304
Mercy Cancer Center - Rocklin
Rocklin, California 95765
Rocklin, California 95765
Mercy Cancer Center - Sacramento
Sacramento, California 95816
Sacramento, California 95816
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
Sacramento, California 95817
Contact:
Site Public Contact
916-734-3089
Site Public Contact
916-734-3089
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California 93401
San Luis Obispo, California 93401
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California 93444
Santa Maria, California 93444
Torrance Memorial Physician Network - Cancer Care
Torrance, California 90505
Torrance, California 90505
Torrance Memorial Medical Center
Torrance, California 90509
Torrance, California 90509
Contact:
Site Public Contact
310-517-4665
Site Public Contact
310-517-4665
Woodland Memorial Hospital
Woodland, California 95695
Woodland, California 95695
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
Saint Francis Cancer Center
Colorado Springs, Colorado 80923
Colorado Springs, Colorado 80923
Porter Adventist Hospital
Denver, Colorado 80210
Denver, Colorado 80210
Mercy Medical Center
Durango, Colorado 81301
Durango, Colorado 81301
Southwest Oncology PC
Durango, Colorado 81301
Durango, Colorado 81301
Saint Anthony Hospital
Lakewood, Colorado 80228
Lakewood, Colorado 80228
Littleton Adventist Hospital
Littleton, Colorado 80122
Littleton, Colorado 80122
Longmont United Hospital
Longmont, Colorado 80501
Longmont, Colorado 80501
Parker Adventist Hospital
Parker, Colorado 80138
Parker, Colorado 80138
Saint Mary Corwin Medical Center
Pueblo, Colorado 81004
Pueblo, Colorado 81004
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida 33180
Aventura, Florida 33180
Contact:
Site Public Contact
954-461-2180
Site Public Contact
954-461-2180
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida 33146
Coral Gables, Florida 33146
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida 33442
Deerfield Beach, Florida 33442
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
Regional Cancer Center-Lee Memorial Health System
Fort Myers, Florida 33905
Fort Myers, Florida 33905
University of Florida Health Science Center - Gainesville
Gainesville, Florida 32610
Gainesville, Florida 32610
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
Miami, Florida 33136
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida 33176
Miami, Florida 33176
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida 33324
Plantation, Florida 33324
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
Emory University Hospital Midtown
Atlanta, Georgia 30308
Atlanta, Georgia 30308
Contact:
Site Public Contact
888-946-7447
Site Public Contact
888-946-7447
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Contact:
Site Public Contact
404-778-1868
Site Public Contact
404-778-1868
Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
Atlanta, Georgia 30342
Contact:
Site Public Contact
404-851-7115
Site Public Contact
404-851-7115
Low Country Cancer Care
Savannah, Georgia 31404
Savannah, Georgia 31404
Memorial Health University Medical Center
Savannah, Georgia 31404
Savannah, Georgia 31404
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
Boise, Idaho 83712
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
Fruitland, Idaho 83619
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
Meridian, Idaho 83642
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83686
Nampa, Idaho 83686
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301
Twin Falls, Idaho 83301
Saint Anthony's Health
Alton, Illinois 62002
Alton, Illinois 62002
Contact:
Site Public Contact
618-463-5623
Site Public Contact
618-463-5623
Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Bloomington, Illinois 61704
Illinois CancerCare-Canton
Canton, Illinois 61520
Canton, Illinois 61520
Memorial Hospital of Carbondale
Carbondale, Illinois 62902
Carbondale, Illinois 62902
SIH Cancer Institute
Carterville, Illinois 62918
Carterville, Illinois 62918
Illinois CancerCare-Carthage
Carthage, Illinois 62321
Carthage, Illinois 62321
Centralia Oncology Clinic
Centralia, Illinois 62801
Centralia, Illinois 62801
Saint Mary's Hospital
Centralia, Illinois 62801
Centralia, Illinois 62801
University of Illinois
Chicago, Illinois 60612
Chicago, Illinois 60612
Contact:
Site Public Contact
312-355-3046
Site Public Contact
312-355-3046
University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
Chicago, Illinois 60637
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Decatur, Illinois 62526
Decatur Memorial Hospital
Decatur, Illinois 62526
Decatur, Illinois 62526
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
DeKalb, Illinois 60115
Illinois CancerCare-Dixon
Dixon, Illinois 61021
Dixon, Illinois 61021
Contact:
Site Public Contact
815-285-7800
Site Public Contact
815-285-7800
Crossroads Cancer Center
Effingham, Illinois 62401
Effingham, Illinois 62401
Illinois CancerCare-Eureka
Eureka, Illinois 61530
Eureka, Illinois 61530
Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Galesburg, Illinois 61401
Western Illinois Cancer Treatment Center
Galesburg, Illinois 61401
Galesburg, Illinois 61401
Contact:
Site Public Contact
309-344-2831
Site Public Contact
309-344-2831
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
Geneva, Illinois 60134
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
Kewanee, Illinois 61443
Illinois CancerCare-Macomb
Macomb, Illinois 61455
Macomb, Illinois 61455
Good Samaritan Regional Health Center
Mount Vernon, Illinois 62864
Mount Vernon, Illinois 62864
Contact:
Site Public Contact
618-242-4600
Site Public Contact
618-242-4600
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois 60451
New Lenox, Illinois 60451
Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
University of Chicago Medicine-Orland Park
Orland Park, Illinois 60462
Orland Park, Illinois 60462
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Ottawa, Illinois 61350
Illinois CancerCare-Pekin
Pekin, Illinois 61554
Pekin, Illinois 61554
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois 61554
Pekin, Illinois 61554
Illinois CancerCare-Peoria
Peoria, Illinois 61615
Peoria, Illinois 61615
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois 61615
Peoria, Illinois 61615
Methodist Medical Center of Illinois
Peoria, Illinois 61636
Peoria, Illinois 61636
OSF Saint Francis Medical Center
Peoria, Illinois 61637
Peoria, Illinois 61637
Illinois CancerCare-Peru
Peru, Illinois 61354
Peru, Illinois 61354
Valley Radiation Oncology
Peru, Illinois 61354
Peru, Illinois 61354
Contact:
Site Public Contact
815-664-4141
Site Public Contact
815-664-4141
Illinois CancerCare-Princeton
Princeton, Illinois 61356
Princeton, Illinois 61356
Southern Illinois University School of Medicine
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929
Site Public Contact
217-545-7929
Springfield Clinic
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541
Site Public Contact
800-444-7541
Memorial Medical Center
Springfield, Illinois 62781
Springfield, Illinois 62781
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
Warrenville, Illinois 60555
Illinois CancerCare - Washington
Washington, Illinois 61571
Washington, Illinois 61571
Reid Health
Richmond, Indiana 47374
Richmond, Indiana 47374
Saint Anthony Regional Hospital
Carroll, Iowa 51401
Carroll, Iowa 51401
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa 50325
Clive, Iowa 50325
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
Mercy Cancer Center-West Lakes
Clive, Iowa 50325
Clive, Iowa 50325
Alegent Health Mercy Hospital
Council Bluffs, Iowa 51503
Council Bluffs, Iowa 51503
Greater Regional Medical Center
Creston, Iowa 50801
Creston, Iowa 50801
Iowa Methodist Medical Center
Des Moines, Iowa 50309
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-6727
Site Public Contact
515-241-6727
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa 50309
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
Broadlawns Medical Center
Des Moines, Iowa 50314
Des Moines, Iowa 50314
Contact:
Site Public Contact
515-282-2200
Site Public Contact
515-282-2200
Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
Des Moines, Iowa 50314
Mission Cancer and Blood - Laurel
Des Moines, Iowa 50314
Des Moines, Iowa 50314
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
Iowa Lutheran Hospital
Des Moines, Iowa 50316
Des Moines, Iowa 50316
Contact:
Site Public Contact
515-241-8704
Site Public Contact
515-241-8704
Trinity Regional Medical Center
Fort Dodge, Iowa 50501
Fort Dodge, Iowa 50501
Contact:
Site Public Contact
515-574-8302
Site Public Contact
515-574-8302
Methodist West Hospital
West Des Moines, Iowa 50266-7700
West Des Moines, Iowa 50266-7700
Contact:
Site Public Contact
515-343-1000
Site Public Contact
515-343-1000
Mercy Medical Center-West Lakes
West Des Moines, Iowa 50266
West Des Moines, Iowa 50266
Central Care Cancer Center - Garden City
Garden City, Kansas 67846
Garden City, Kansas 67846
Central Care Cancer Center - Great Bend
Great Bend, Kansas 67530
Great Bend, Kansas 67530
Flaget Memorial Hospital
Bardstown, Kentucky 40004
Bardstown, Kentucky 40004
Commonwealth Cancer Center-Corbin
Corbin, Kentucky 40701
Corbin, Kentucky 40701
Saint Joseph Hospital
Lexington, Kentucky 40504
Lexington, Kentucky 40504
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky 40504
Lexington, Kentucky 40504
Saint Joseph Hospital East
Lexington, Kentucky 40509
Lexington, Kentucky 40509
University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
Lexington, Kentucky 40536
Contact:
Site Public Contact
859-257-3379
Site Public Contact
859-257-3379
Saint Joseph London
London, Kentucky 40741
London, Kentucky 40741
Saint Joseph Mount Sterling
Mount Sterling, Kentucky 40353
Mount Sterling, Kentucky 40353
Lowell General Hospital
Lowell, Massachusetts 01854
Lowell, Massachusetts 01854
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Contact:
Site Public Contact
800-865-1125
Site Public Contact
800-865-1125
Bronson Battle Creek
Battle Creek, Michigan 49017
Battle Creek, Michigan 49017
University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan 48116
Brighton, Michigan 48116
Contact:
Site Public Contact
800-865-1125
Site Public Contact
800-865-1125
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Bronson Methodist Hospital
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
West Michigan Cancer Center
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
Ascension Borgess Cancer Center
Kalamazoo, Michigan 49009
Kalamazoo, Michigan 49009
Borgess Medical Center
Kalamazoo, Michigan 49048
Kalamazoo, Michigan 49048
Trinity Health Muskegon Hospital
Muskegon, Michigan 49444
Muskegon, Michigan 49444
Lakeland Hospital Niles
Niles, Michigan 49120
Niles, Michigan 49120
Contact:
Site Public Contact
616-391-1230
Site Public Contact
616-391-1230
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan 49444
Norton Shores, Michigan 49444
Spectrum Health Reed City Hospital
Reed City, Michigan 49677
Reed City, Michigan 49677
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan 49085
Saint Joseph, Michigan 49085
Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
Saint Joseph, Michigan 49085
Munson Medical Center
Traverse City, Michigan 49684
Traverse City, Michigan 49684
Metro Health Hospital
Wyoming, Michigan 49519
Wyoming, Michigan 49519
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
Bemidji, Minnesota 56601
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota 56701
Thief River Falls, Minnesota 56701
Contact:
Site Public Contact
605-312-3320
Site Public Contact
605-312-3320
Sanford Cancer Center Worthington
Worthington, Minnesota 56187
Worthington, Minnesota 56187
Contact:
Site Public Contact
605-312-3320
Site Public Contact
605-312-3320
Baptist Cancer Center-Grenada
Grenada, Mississippi 38901
Grenada, Mississippi 38901
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi 38652
New Albany, Mississippi 38652
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi 38655
Oxford, Mississippi 38655
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi 38671
Southhaven, Mississippi 38671
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri 63011
Ballwin, Missouri 63011
Contact:
Site Public Contact
314-251-7058
Site Public Contact
314-251-7058
Central Care Cancer Center - Bolivar
Bolivar, Missouri 65613
Bolivar, Missouri 65613
Cox Cancer Center Branson
Branson, Missouri 65616
Branson, Missouri 65616
Contact:
Site Public Contact
417-269-4520
Site Public Contact
417-269-4520
Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
Southeast Cancer Center
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
Contact:
Site Public Contact
573-651-5550
Site Public Contact
573-651-5550
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
Creve Coeur, Missouri 63141
Parkland Health Center - Farmington
Farmington, Missouri 63640
Farmington, Missouri 63640
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Capital Region Southwest Campus
Jefferson City, Missouri 65109
Jefferson City, Missouri 65109
Freeman Health System
Joplin, Missouri 64804
Joplin, Missouri 64804
Mercy Hospital Joplin
Joplin, Missouri 64804
Joplin, Missouri 64804
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri 65401
Rolla, Missouri 65401
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri 65401
Rolla, Missouri 65401
Contact:
Site Public Contact
573-458-6379
Site Public Contact
573-458-6379
Heartland Regional Medical Center
Saint Joseph, Missouri 64506
Saint Joseph, Missouri 64506
Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri 63109
Saint Louis, Missouri 63109
Contact:
Site Public Contact
314-353-1870
Site Public Contact
314-353-1870
Washington University School of Medicine
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Siteman Cancer Center-South County
Saint Louis, Missouri 63129
Saint Louis, Missouri 63129
Missouri Baptist Medical Center
Saint Louis, Missouri 63131
Saint Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Siteman Cancer Center at Christian Hospital
Saint Louis, Missouri 63136
Saint Louis, Missouri 63136
Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Saint Louis, Missouri 63141
Contact:
Site Public Contact
314-251-7066
Site Public Contact
314-251-7066
Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri 63376
Saint Peters, Missouri 63376
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
Sainte Genevieve, Missouri 63670
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Mercy Hospital Springfield
Springfield, Missouri 65804
Springfield, Missouri 65804
Contact:
Site Public Contact
417-269-4520
Site Public Contact
417-269-4520
CoxHealth South Hospital
Springfield, Missouri 65807
Springfield, Missouri 65807
Contact:
Site Public Contact
417-269-4520
Site Public Contact
417-269-4520
Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
Sullivan, Missouri 63080
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri 63127
Sunset Hills, Missouri 63127
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Mercy Hospital Washington
Washington, Missouri 63090
Washington, Missouri 63090
Contact:
Site Public Contact
636-390-1600
Site Public Contact
636-390-1600
Saint Patrick Hospital - Community Hospital
Missoula, Montana 59802
Missoula, Montana 59802
CHI Health Good Samaritan
Kearney, Nebraska 68847
Kearney, Nebraska 68847
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska 68510
Lincoln, Nebraska 68510
Alegent Health Immanuel Medical Center
Omaha, Nebraska 68122
Omaha, Nebraska 68122
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska 68124
Omaha, Nebraska 68124
Alegent Health Lakeside Hospital
Omaha, Nebraska 68130
Omaha, Nebraska 68130
Creighton University Medical Center
Omaha, Nebraska 68131
Omaha, Nebraska 68131
Midlands Community Hospital
Papillion, Nebraska 68046
Papillion, Nebraska 68046
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
Basking Ridge, New Jersey 07920
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
Middletown, New Jersey 07748
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
Montvale, New Jersey 07645
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Albany Medical Center
Albany, New York 12208
Albany, New York 12208
Contact:
Site Public Contact
518-262-5513
Site Public Contact
518-262-5513
Memorial Sloan Kettering Commack
Commack, New York 11725
Commack, New York 11725
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Queens Medical Associates PC
Fresh Meadows, New York 11366
Fresh Meadows, New York 11366
Contact:
Site Public Contact
718-312-3446
Site Public Contact
718-312-3446
Memorial Sloan Kettering Westchester
Harrison, New York 10604
Harrison, New York 10604
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Northwell Health/Center for Advanced Medicine
Lake Success, New York 11042
Lake Success, New York 11042
Contact:
Site Public Contact
516-734-8896
Site Public Contact
516-734-8896
North Shore University Hospital
Manhasset, New York 11030
Manhasset, New York 11030
Contact:
Site Public Contact
516-734-8896
Site Public Contact
516-734-8896
Long Island Jewish Medical Center
New Hyde Park, New York 11040
New Hyde Park, New York 11040
Contact:
Site Public Contact
516-734-8896
Site Public Contact
516-734-8896
Memorial Sloan Kettering Cancer Center
New York, New York 10065
New York, New York 10065
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Stony Brook University Medical Center
Stony Brook, New York 11794
Stony Brook, New York 11794
Contact:
Site Public Contact
800-862-2215
Site Public Contact
800-862-2215
Memorial Sloan Kettering Nassau
Uniondale, New York 11553
Uniondale, New York 11553
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Duke University Medical Center
Durham, North Carolina 27710
Durham, North Carolina 27710
Contact:
Site Public Contact
888-275-3853
Site Public Contact
888-275-3853
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
Contact:
Site Public Contact
336-713-6771
Site Public Contact
336-713-6771
Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
Sanford South University Medical Center
Fargo, North Dakota 58103
Fargo, North Dakota 58103
Contact:
Site Public Contact
701-234-6161
Site Public Contact
701-234-6161
Southpointe-Sanford Medical Center Fargo
Fargo, North Dakota 58103
Fargo, North Dakota 58103
Contact:
Site Public Contact
605-312-3320
Site Public Contact
605-312-3320
Sanford Medical Center Fargo
Fargo, North Dakota 58104
Fargo, North Dakota 58104
Contact:
Site Public Contact
800-437-4010
Site Public Contact
800-437-4010
Sanford Broadway Medical Center
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Indu and Raj Soin Medical Center
Beavercreek, Ohio 45431
Beavercreek, Ohio 45431
Saint Elizabeth Boardman Hospital
Boardman, Ohio 44512
Boardman, Ohio 44512
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio 45459
Centerville, Ohio 45459
Miami Valley Hospital South
Centerville, Ohio 45459
Centerville, Ohio 45459
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio 45220
Cincinnati, Ohio 45220
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio 45236
Cincinnati, Ohio 45236
Bethesda North Hospital
Cincinnati, Ohio 45242
Cincinnati, Ohio 45242
TriHealth Cancer Institute-Westside
Cincinnati, Ohio 45247
Cincinnati, Ohio 45247
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio 45255
Cincinnati, Ohio 45255
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Columbus, Ohio 43210
Dayton Blood and Cancer Center
Dayton, Ohio 45409
Dayton, Ohio 45409
Contact:
Site Public Contact
937-276-8320
Site Public Contact
937-276-8320
Miami Valley Hospital
Dayton, Ohio 45409
Dayton, Ohio 45409
Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio 45415
Dayton, Ohio 45415
Miami Valley Hospital North
Dayton, Ohio 45415
Dayton, Ohio 45415
Armes Family Cancer Center
Findlay, Ohio 45840
Findlay, Ohio 45840
Blanchard Valley Hospital
Findlay, Ohio 45840
Findlay, Ohio 45840
Orion Cancer Care
Findlay, Ohio 45840
Findlay, Ohio 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
Franklin, Ohio 45005-1066
Dayton Physicians LLC-Atrium
Franklin, Ohio 45005
Franklin, Ohio 45005
Dayton Physicians LLC-Wayne
Greenville, Ohio 45331
Greenville, Ohio 45331
Wayne Hospital
Greenville, Ohio 45331
Greenville, Ohio 45331
Greater Dayton Cancer Center
Kettering, Ohio 45409
Kettering, Ohio 45409
Kettering Medical Center
Kettering, Ohio 45429
Kettering, Ohio 45429
Dayton Physicians LLC - Troy
Troy, Ohio 45373
Troy, Ohio 45373
Upper Valley Medical Center
Troy, Ohio 45373
Troy, Ohio 45373
Saint Joseph Warren Hospital
Warren, Ohio 44484
Warren, Ohio 44484
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio 44501
Youngstown, Ohio 44501
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120
Oklahoma City, Oklahoma 73120
Contact:
Site Public Contact
405-752-3402
Site Public Contact
405-752-3402
Saint Charles Health System
Bend, Oregon 97701
Bend, Oregon 97701
Clackamas Radiation Oncology Center
Clackamas, Oregon 97015
Clackamas, Oregon 97015
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon 97015
Clackamas, Oregon 97015
Bay Area Hospital
Coos Bay, Oregon 97420
Coos Bay, Oregon 97420
Legacy Mount Hood Medical Center
Gresham, Oregon 97030
Gresham, Oregon 97030
Contact:
Site Public Contact
503-413-2150
Site Public Contact
503-413-2150
Providence Newberg Medical Center
Newberg, Oregon 97132
Newberg, Oregon 97132
Providence Willamette Falls Medical Center
Oregon City, Oregon 97045
Oregon City, Oregon 97045
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon 97210
Portland, Oregon 97210
Providence Portland Medical Center
Portland, Oregon 97213
Portland, Oregon 97213
Providence Saint Vincent Medical Center
Portland, Oregon 97225
Portland, Oregon 97225
Oregon Health and Science University
Portland, Oregon 97239
Portland, Oregon 97239
Saint Charles Health System-Redmond
Redmond, Oregon 97756
Redmond, Oregon 97756
Contact:
Site Public Contact
541-706-2909
Site Public Contact
541-706-2909
Legacy Meridian Park Hospital
Tualatin, Oregon 97062
Tualatin, Oregon 97062
Contact:
Site Public Contact
503-413-1742
Site Public Contact
503-413-1742
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033-0850
Hershey, Pennsylvania 17033-0850
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Contact:
Site Public Contact
800-474-9892
Site Public Contact
800-474-9892
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Medical University of South Carolina
Charleston, South Carolina 29425
Charleston, South Carolina 29425
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Sioux Falls, South Dakota 57117-5134
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee 38017
Collierville, Tennessee 38017
University of Tennessee - Knoxville
Knoxville, Tennessee 37920
Knoxville, Tennessee 37920
Contact:
Site Public Contact
865-544-9773
Site Public Contact
865-544-9773
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee 38120
Memphis, Tennessee 38120
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Contact:
Site Public Contact
800-811-8480
Site Public Contact
800-811-8480
Parkland Memorial Hospital
Dallas, Texas 75235
Dallas, Texas 75235
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
Dallas, Texas 75390
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas 75080
Richardson, Texas 75080
Inova Schar Cancer Institute
Fairfax, Virginia 22031
Fairfax, Virginia 22031
Inova Fairfax Hospital
Falls Church, Virginia 22042
Falls Church, Virginia 22042
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington 98520
Aberdeen, Washington 98520
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington 98225
Bellingham, Washington 98225
Contact:
Site Public Contact
360-788-8223
Site Public Contact
360-788-8223
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington 98310
Bremerton, Washington 98310
Providence Regional Cancer System-Centralia
Centralia, Washington 98531
Centralia, Washington 98531
Swedish Cancer Institute-Edmonds
Edmonds, Washington 98026
Edmonds, Washington 98026
Providence Regional Cancer Partnership
Everett, Washington 98201
Everett, Washington 98201
Swedish Cancer Institute-Issaquah
Issaquah, Washington 98029
Issaquah, Washington 98029
Kadlec Clinic Hematology and Oncology
Kennewick, Washington 99336
Kennewick, Washington 99336
Providence Regional Cancer System-Lacey
Lacey, Washington 98503
Lacey, Washington 98503
PeaceHealth Saint John Medical Center
Longview, Washington 98632
Longview, Washington 98632
Virginia Mason Medical Center
Seattle, Washington 98101
Seattle, Washington 98101
Swedish Medical Center-Ballard Campus
Seattle, Washington 98107
Seattle, Washington 98107
Swedish Medical Center-Cherry Hill
Seattle, Washington 98122-5711
Seattle, Washington 98122-5711
Swedish Medical Center-First Hill
Seattle, Washington 98122
Seattle, Washington 98122
PeaceHealth United General Medical Center
Sedro-Woolley, Washington 98284
Sedro-Woolley, Washington 98284
Providence Regional Cancer System-Shelton
Shelton, Washington 98584
Shelton, Washington 98584
PeaceHealth Southwest Medical Center
Vancouver, Washington 98664
Vancouver, Washington 98664
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver, Washington 98684
Vancouver, Washington 98684
Legacy Salmon Creek Hospital
Vancouver, Washington 98686
Vancouver, Washington 98686
Contact:
Site Public Contact
503-413-2150
Site Public Contact
503-413-2150
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington 99362
Walla Walla, Washington 99362
Providence Regional Cancer System-Yelm
Yelm, Washington 98597
Yelm, Washington 98597
United Hospital Center
Bridgeport, West Virginia 26330
Bridgeport, West Virginia 26330
WVUH-Berkely Medical Center
Martinsburg, West Virginia 25401
Martinsburg, West Virginia 25401
West Virginia University Healthcare
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
Camden Clark Medical Center
Parkersburg, West Virginia 26101
Parkersburg, West Virginia 26101
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
Eau Claire, Wisconsin 54701
Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
La Crosse, Wisconsin 54601
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin 53792
Madison, Wisconsin 53792
Contact:
Site Public Contact
800-622-8922
Site Public Contact
800-622-8922
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
Marshfield, Wisconsin 54449
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin 54548
Minocqua, Wisconsin 54548
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
Rice Lake, Wisconsin 54868
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
Stevens Point, Wisconsin 54482
Marshfield Medical Center - Weston
Weston, Wisconsin 54476
Weston, Wisconsin 54476
More Details
- NCT ID
- NCT04559139
- Status
- Recruiting
- Sponsor
- ECOG-ACRIN Cancer Research Group
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.