S1201: Combination Chemo for Patients W/Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer

October 25, 2019 updated by: Southwest Oncology Group

A Randomized Phase II Pilot Study Prospectively Evaluating Treatment for Patients Based on ERCC1(Excision Repair Cross-Complementing 1) for Advanced/Metastatic Esophageal, Gastric or Gastroesophageal Junction (GEJ) Cancer

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, irinotecan hydrochloride, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective in treating tumor cells.

PURPOSE: This randomized phase II trial studies how well oxaliplatin, leucovorin calcium, and fluorouracil work compared to irinotecan hydrochloride and docetaxel in treating patients with esophageal cancer, gastric cancer, or gastroesophageal junction cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

To assess progression-free survival of high-excision repair cross-complementing 1(ERCC1) patients with advanced or metastatic cancer of the esophagus, stomach, or gastroesophageal junction (GEJ) treated with FOLFOX comprising oxaliplatin, leucovorin calcium, and fluorouracil compared to those treated with irinotecan hydrochloride plus docetaxel.
To assess progression-free survival of low-ERCC1 patients with advanced or metastatic cancer of the esophagus, stomach, or GEJ treated with FOLFOX compared to those treated with irinotecan hydrochloride plus docetaxel.
To assess progression-free survival of low-ERCC1 patients with advanced or metastatic cancer of the esophagus, stomach, or GEJ treated with FOLFOX compared to high-ERCC1 patients treated with FOLFOX.
To assess overall survival of and toxicities in each of the two treatment arms in this group of patients.
To assess the response probability (confirmed and unconfirmed, complete and partial responses) in the subset of patients with measurable disease in each of the two treatment arms.
To explore whether there is evidence of interaction between treatment arm and ERCC1 expression in this group of patients. (Exploratory)
To bank tissue and blood for future translational medicine studies; a) To explore the relationship of ERCC-1 and ERCC-2 single nucleotide polymorphism (SNP) genotypes with clinical outcome in these patients; and b) To explore the association between germline variations in these SNPs and ERCC-1 mRNA expression in these patients. (Exploratory)

OUTLINE: This is a multicenter study. Patients are stratified according to ERCC1 expression (high [≥ 1.7] vs low [< 1.7]), and disease site (esophageal vs gastric/gastroesophageal junction). Patients are randomized to 1 of 2 treatment arms.

Arm I (FOLFOX): Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Blood and tumor tissue samples may be collected for ERCC1 expression analysis and future research studies.

After completion of study treatment, patients are followed up every 3 months for up to 3 years.

Study Type

Interventional

Enrollment (Actual)

213

Phase

Phase 2

Contacts and Locations

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

Study Locations

United States
- Alabama
  - Mobile, Alabama, United States, 36688
    - University of South Alabama Mitchell Cancer Institute
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - University of Arkansas for Medical Sciences
- California
  - Auburn, California, United States, 95602
    - Sutter Auburn Faith Hospital
  - Berkeley, California, United States, 94704
    - Alta Bates Summit Medical Center-Herrick Campus
  - Burlingame, California, United States, 94010
    - Mills - Peninsula Hospitals
  - Davis, California, United States, 95616
    - Sutter Davis Hospital
  - Los Angeles, California, United States, 90033
    - Los Angeles County-USC Medical Center
  - Los Angeles, California, United States, 90033
    - University of Southern California/Norris Cancer Center
  - Marysville, California, United States, 95901
    - Fremont - Rideout Cancer Center
  - Modesto, California, United States, 95355
    - Memorial Medical Center
  - Mountain View, California, United States, 94040
    - Palo Alto Medical Foundation-Camino Division
  - Mountain View, California, United States, 94040
    - Palo Alto Medical Foundation-Gynecologic Oncology
  - Novato, California, United States, 94945
    - Sutter Cancer Research Consortium
  - Orange, California, United States, 92868
    - University of California Medical Center At Irvine-Orange Campus
  - Palo Alto, California, United States, 94301
    - Palo Alto Medical Foundation Health Care
  - Pleasanton, California, United States, 94588
    - Valley Medical Oncology Consultants
  - Roseville, California, United States, 95661
    - Sutter Roseville Medical Center
  - Sacramento, California, United States, 95817
    - University of California at Davis Cancer Center
  - Sacramento, California, United States, 95816
    - Sutter General Hospital
  - San Francisco, California, United States, 94118
    - California Pacific Medical Center-Pacific Campus
  - Santa Cruz, California, United States, 95065
    - Palo Alto Medical Foundation-Santa Cruz
  - Santa Rosa, California, United States, 95403
    - Sutter Pacific Medical Foundation
  - Sunnyvale, California, United States, 94806
    - Palo Atlo Medical Foundation-Sunnyvale
  - Truckee, California, United States, 96161
    - Tahoe Forest Cancer Center
  - Vallejo, California, United States, 94589
    - Sutter Solano Medical Center/Cancer Center
- Colorado
  - Aurora, Colorado, United States, 80012
    - The Medical Center of Aurora
  - Boulder, Colorado, United States, 80301
    - Boulder Community Hospital
  - Boulder, Colorado, United States, 80304
    - Rocky Mountain Cancer Centers-Boulder
  - Colorado Springs, Colorado, United States, 80907
    - Penrose-Saint Francis Healthcare
  - Colorado Springs, Colorado, United States, 80907
    - Rocky Mountain Cancer Centers-Penrose
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, United States, 80218
    - Presbyterian - Saint Lukes Medical Center - Health One
  - Denver, Colorado, United States, 80220
    - Rose Medical Center
  - Denver, Colorado, United States, 80218
    - Exempla Saint Joseph Hospital
  - Denver, Colorado, United States, 80218
    - Rocky Mountain Cancer Centers-Midtown
  - Denver, Colorado, United States, 80220
    - Rocky Mountain Cancer Centers-Rose
  - Denver, Colorado, United States, 80907
    - Colorado Blood Cancer Institute
  - Denver, Colorado, United States, 80224-2522
    - Colorado Cancer Research Program CCOP
  - Durango, Colorado, United States, 81301
    - Mercy Medical Center
  - Englewood, Colorado, United States, 80113
    - Swedish Medical Center
  - Englewood, Colorado, United States, 80113
    - Comprehensive Cancer Care and Research Institute of Colorado LLC
  - Fort Collins, Colorado, United States, 80524
    - Poudre Valley Hospital
  - Golden, Colorado, United States, 80401
    - Mountain Blue Cancer Care Center
  - Greeley, Colorado, United States, 80631
    - North Colorado Medical Center
  - Greenwood Village, Colorado, United States, 80111
    - Breast Cancer Care Consultants
  - Lakewood, Colorado, United States, 80228
    - Saint Anthony Hospital
  - Lakewood, Colorado, United States, 80228
    - Rocky Mountain Cancer Centers-Lakewood
  - Littleton, Colorado, United States, 80122
    - Littleton Adventist Hospital
  - Lone Tree, Colorado, United States, 80124
    - Sky Ridge Medical Center
  - Lone Tree, Colorado, United States, 80124
    - Rocky Mountain Cancer Centers-Sky Ridge
  - Longmont, Colorado, United States, 80501
    - Longmont United Hospital
  - Longmont, Colorado, United States, 80501
    - Rocky Mountain Cancer Centers-Longmont
  - Loveland, Colorado, United States, 80539
    - McKee Medical Center
  - Parker, Colorado, United States, 80138
    - Parker Adventist Hospital
  - Parker, Colorado, United States, 80138
    - Rocky Mountain Cancer Centers-Parker
  - Pueblo, Colorado, United States, 81004
    - Saint Mary Corwin Medical Center
  - Pueblo, Colorado, United States, 81008
    - Rocky Mountain Cancer Centers - Pueblo
  - Wheat Ridge, Colorado, United States, 80033
    - Exempla Lutheran Medical Center
- Connecticut
  - Hartford, Connecticut, United States, 06105
    - Saint Francis Hospital and Medical Center
- Delaware
  - Lewes, Delaware, United States, 19958
    - Beebe Medical Center
  - Newark, Delaware, United States, 19713
    - Helen F Graham Cancer Center
  - Newark, Delaware, United States, 19713
    - Delaware Clinical and Laboratory Physicians PA
  - Newark, Delaware, United States, 19713
    - Medical Oncology Hematology Consultants PA
  - Newark, Delaware, United States, 19718
    - Christiana Care Health System-Christiana Hospital
  - Newark, Delaware, United States, 19713
    - Christiana Gynecologic Oncology LLC
  - Newark, Delaware, United States, 19713
    - Regional Hematology and Oncology PA
  - Rehoboth Beach, Delaware, United States, 19971
    - Beebe Health Campus
  - Seaford, Delaware, United States, 19973
    - Nanticoke Memorial Hospital
  - Wilmington, Delaware, United States, 19801
    - Christiana Care Health System-Wilmington Hospital
- Florida
  - Fort Lauderdale, Florida, United States, 33316
    - Broward Health Medical Center
  - Fort Lauderdale, Florida, United States, 33308
    - Holy Cross Hospital
  - Hollywood, Florida, United States, 33021
    - Memorial Healthcare System - Joe DiMaggio Children's Hospital
  - Jupiter, Florida, United States, 33458
    - Jupiter Medical Center
  - Miami Beach, Florida, United States, 33140
    - Mount Sinai Medical Center
  - Orlando, Florida, United States, 32803
    - Florida Hospital
  - Pembroke Pines, Florida, United States, 33028
    - Memorial Hospital West
- Georgia
  - Albany, Georgia, United States, 31701
    - Phoebe Putney Memorial Hospital
  - Columbus, Georgia, United States, 31904
    - John B Amos Cancer Center
  - Savannah, Georgia, United States, 31404
    - Memorial University Medical Center
- Hawaii
  - 'Aiea, Hawaii, United States, 96701
    - Pali Momi Medical Center
  - 'Aiea, Hawaii, United States, 96701
    - Oncare Hawaii Inc-Pali Momi
  - Honolulu, Hawaii, United States, 96813
    - Queen's Medical Center
  - Honolulu, Hawaii, United States, 96813
    - Straub Clinic and Hospital
  - Honolulu, Hawaii, United States, 96813
    - University of Hawaii Cancer Center
  - Honolulu, Hawaii, United States, 96817
    - Kuakini Medical Center
  - Honolulu, Hawaii, United States, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, United States, 96813
    - Oncare Hawaii Inc-POB II
  - Honolulu, Hawaii, United States, 96817-3169
    - OnCare Hawaii-Liliha
  - Honolulu, Hawaii, United States, 96817
    - Oncare Hawaii Inc-Kuakini
  - Kailua, Hawaii, United States, 96734
    - Castle Medical Center
  - Lihue, Hawaii, United States, 96766
    - Wilcox Memorial Hospital and Kauai Medical Clinic
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center-Boise
  - Lewiston, Idaho, United States, 83501
    - Saint Joseph Regional Medical Center
  - Meridian, Idaho, United States, 83642
    - Idaho Urologic Institute-Meredian
  - Post Falls, Idaho, United States, 83854
    - Kootenai Cancer Center
- Illinois
  - Alton, Illinois, United States, 62002
    - Saint Anthony's Health
  - Bloomington, Illinois, United States, 61701
    - Saint Joseph Medical Center
  - Bloomington, Illinois, United States, 61701
    - Illinois CancerCare-Bloomington
  - Canton, Illinois, United States, 61520
    - Illinois CancerCare-Canton
  - Canton, Illinois, United States, 61520
    - Graham Hospital Association
  - Carbondale, Illinois, United States, 62902
    - Memorial Hospital of Carbondale
  - Carthage, Illinois, United States, 62321
    - Illinois CancerCare-Carthage
  - Carthage, Illinois, United States, 62321
    - Memorial Hospital
  - Centralia, Illinois, United States, 62801
    - Centralia Oncology Clinic
  - Chicago, Illinois, United States, 60611
    - Northwestern University
  - Chicago, Illinois, United States, 60612
    - University of Illinois
  - Chicago, Illinois, United States, 60611
    - Hematology and Oncology Associates
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital
  - Decatur, Illinois, United States, 62526
    - Cancer Care Center of Decatur
  - Decatur, Illinois, United States, 62526
    - Central Illinois CCOP
  - Effingham, Illinois, United States, 62401
    - Crossroads Cancer Center
  - Eureka, Illinois, United States, 61530
    - Illinois CancerCare-Eureka
  - Eureka, Illinois, United States, 61530
    - Eureka Hospital
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare Galesburg
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare-Galesburg Cottage Plaza Office
  - Havana, Illinois, United States, 62644
    - Mason District Hospital
  - Havana, Illinois, United States, 62644
    - Illinois CancerCare-Havana
  - Highland Park, Illinois, United States, 60035
    - Hematology Oncology Associates of Illinois-Highland Park
  - Kankakee, Illinois, United States, 60901
    - Presence Saint Mary's Hospital
  - Kewanee, Illinois, United States, 61443
    - Illinois CancerCare-Kewanee Clinic
  - La Grange, Illinois, United States, 60525
    - Adventist La Grange Memorial Hospital
  - Libertyville, Illinois, United States, 60048
    - North Shore Hematology Oncology
  - Macomb, Illinois, United States, 61455
    - Illinois CancerCare-Macomb
  - Macomb, Illinois, United States, 61455
    - Mcdonough District Hospital
  - Maywood, Illinois, United States, 60153
    - Loyola University Medical Center
  - Moline, Illinois, United States, 61265
    - Garneau, Stewart C MD (UIA Investigator)
  - Moline, Illinois, United States, 61265
    - Porubcin, Michael MD (UIA Investigator)
  - Moline, Illinois, United States, 61265
    - Spector, David MD (UIA Investigator)
  - Moline, Illinois, United States, 61265
    - Trinity Medical Center
  - Monmouth, Illinois, United States, 61462
    - Illinois CancerCare-Monmouth
  - Monmouth, Illinois, United States, 61462
    - Holy Family Medical Center
  - Mount Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - Naperville, Illinois, United States, 60540
    - Hematology Oncology Consultants Limited
  - Niles, Illinois, United States, 60714
    - Illinois Cancer Specialists-Niles
  - Normal, Illinois, United States, 61761
    - Community Cancer Center Foundation
  - Normal, Illinois, United States, 61761
    - Bromenn Regional Medical Center
  - Normal, Illinois, United States, 61761
    - Illinois CancerCare-Community Cancer Center
  - Ottawa, Illinois, United States, 61350
    - Illinois CancerCare-Ottawa Clinic
  - Ottawa, Illinois, United States, 61350
    - Ottawa Regional Hospital and Healthcare Center
  - Pekin, Illinois, United States, 61554
    - Illinois CancerCare-Pekin
  - Pekin, Illinois, United States, 61554
    - Pekin Cancer Treatment Center
  - Peoria, Illinois, United States, 61637
    - OSF Saint Francis Medical Center
  - Peoria, Illinois, United States, 61615
    - Illinois CancerCare-Peoria
  - Peoria, Illinois, United States, 61614
    - Proctor Hospital
  - Peoria, Illinois, United States, 61603
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, United States, 61615
    - Illinois Oncology Research Association CCOP
  - Peru, Illinois, United States, 61354
    - Illinois CancerCare-Peru
  - Peru, Illinois, United States, 61354
    - Illinois Valley Hospital
  - Princeton, Illinois, United States, 61356
    - Illinois CancerCare-Princeton
  - Princeton, Illinois, United States, 61356
    - Perry Memorial Hospital
  - Rockford, Illinois, United States, 61107
    - SwedishAmerican Regional Cancer Center/ACT
  - Skokie, Illinois, United States, 60076
    - Hematology Oncology Associates of Illinois - Skokie
  - Spring Valley, Illinois, United States, 61362
    - Illinois CancerCare-Spring Valley
  - Springfield, Illinois, United States, 62781-0001
    - Memorial Medical Center
- Indiana
  - Elkhart, Indiana, United States, 46515
    - Elkhart General Hospital
  - Elkhart, Indiana, United States, 46514
    - Michiana Hematology Oncology PC-Elkhart
  - Elkhart, Indiana, United States, 46514-2098
    - Elkhart Clinic
  - Fort Wayne, Indiana, United States, 46845
    - Fort Wayne Medical Oncology and Hematology Inc-Parkview
  - Indianapolis, Indiana, United States, 46237
    - Franciscan Saint Francis Health-Indianapolis
  - Kokomo, Indiana, United States, 46904
    - Community Howard Regional Health
  - La Porte, Indiana, United States, 46350
    - IU Health La Porte Hospital
  - Merrillville, Indiana, United States, 46410
    - Premier Oncology Hematology Associates
  - Mishawaka, Indiana, United States, 46544
    - Memorial Regional Cancer Center Day Road
  - Mishawaka, Indiana, United States, 46545-1470
    - Saint Joseph Regional Medical Center-Mishawaka
  - Mishawaka, Indiana, United States, 46545
    - Cancer Care Partners LLC
  - Mishawaka, Indiana, United States, 46545-1470
    - Michiana Hematology Oncology PC-Mishawaka
  - Plymouth, Indiana, United States, 46563
    - Michiana Hematology Oncology PC-Plymouth
  - Richmond, Indiana, United States, 47374
    - Reid Hospital and Health Care Services
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46601
    - Michiana Hematology Oncology PC-South Bend
  - South Bend, Indiana, United States, 46628
    - Northern Indiana Cancer Research Consortium
  - South Bend, Indiana, United States, 46617
    - South Bend Clinic
  - Westville, Indiana, United States, 46391
    - Michiana Hematology Oncology-PC Westville
- Iowa
  - Ames, Iowa, United States, 50010
    - Mary Greeley Medical Center
  - Ames, Iowa, United States, 50010
    - McFarland Clinic PC-William R Bliss Cancer Center
  - Bettendorf, Iowa, United States, 52722
    - Constantinou, Costas L MD (UIA Investigator)
  - Bettendorf, Iowa, United States, 52722
    - Hematology Oncology Associates-Quad Cities
  - Boone, Iowa, United States, 50036
    - McFarland Clinic PC-Boone
  - Davenport, Iowa, United States, 52803
    - Genesis Medical Center - East Campus
  - Fort Dodge, Iowa, United States, 50501
    - McFarland Clinic PC-Trinity Cancer Center
  - Jefferson, Iowa, United States, 50129
    - McFarland Clinic PC-Jefferson
  - Marshalltown, Iowa, United States, 50158
    - McFarland Clinic PC-Marshalltown
  - Sioux City, Iowa, United States, 51104
    - Saint Luke's Regional Medical Center
  - Sioux City, Iowa, United States, 51101
    - Siouxland Hematology Oncology Associates
  - Sioux City, Iowa, United States, 51104
    - Mercy Medical Center-Sioux City
  - Waterloo, Iowa, United States, 50702
    - Covenant Medical Center
- Kansas
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas - Chanute
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas - Dodge City
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas - El Dorado
  - Emporia, Kansas, United States, 66801
    - Newman Regional Health
  - Fort Scott, Kansas, United States, 66701
    - Cancer Center of Kansas - Fort Scott
  - Garden City, Kansas, United States, 67846
    - Saint Catherine Hospital
  - Great Bend, Kansas, United States, 67530
    - Saint Rose Ambulatory and Surgery Center
  - Hays, Kansas, United States, 67601
    - Hays Medical Center
  - Hutchinson, Kansas, United States, 65702
    - Promise Regional Medical Center-Hutchinson
  - Independence, Kansas, United States, 67301
    - Cancer Center of Kansas-Independence
  - Kansas City, Kansas, United States, 66160
    - University of Kansas Medical Center
  - Kansas City, Kansas, United States, 66112
    - Kansas City Cancer Center-West
  - Kansas City, Kansas, United States, 66112
    - Providence Medical Center
  - Kingman, Kansas, United States, 67068
    - Cancer Center of Kansas-Kingman
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Liberal, Kansas, United States, 67901
    - Cancer Center of Kansas-Liberal
  - Manhattan, Kansas, United States, 66502
    - Cancer Center of Kansas-Manhattan
  - McPherson, Kansas, United States, 67460
    - Cancer Center of Kansas - McPherson
  - Newton, Kansas, United States, 67114
    - Cancer Center of Kansas - Newton
  - Overland Park, Kansas, United States, 66209
    - Menorah Medical Center
  - Overland Park, Kansas, United States, 66213
    - Saint Luke's South Hospital
  - Overland Park, Kansas, United States, 66210
    - Kansas City Cancer Centers-Southwest
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas - Parsons
  - Pittsburg, Kansas, United States, 66762
    - Via Christi Hospital-Pittsburg
  - Prairie Village, Kansas, United States, 66208
    - Kansas City CCOP
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas - Pratt
  - Salina, Kansas, United States, 67401
    - Salina Regional Health Center
  - Salina, Kansas, United States, 67401
    - Cancer Center of Kansas - Salina
  - Shawnee Mission, Kansas, United States, 66204
    - Kansas City Cancer Center-Shawnee Mission
  - Topeka, Kansas, United States, 66606
    - Saint Francis Hospital and Medical Center - Topeka
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas - Wellington
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas-Wichita Medical Arts Tower
  - Wichita, Kansas, United States, 67208
    - Associates In Womens Health
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas - Main Office
  - Wichita, Kansas, United States, 67214
    - Via Christi Regional Medical Center
  - Wichita, Kansas, United States, 67214
    - Wichita CCOP
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas - Winfield
- Kentucky
  - Crestview Hills, Kentucky, United States, 41017
    - Oncology Hematology Care Inc-Crestview
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Ochsner Health Center-Summa
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Medical Center Jefferson
  - New Orleans, Louisiana, United States, 70115
    - Ochsner Baptist Medical Center
  - Shreveport, Louisiana, United States, 71130
    - Louisiana State University Health Sciences Center Shreveport
- Maine
  - Augusta, Maine, United States, 04330
    - Harold Alfond Center for Cancer Care
  - Bangor, Maine, United States, 04401
    - Eastern Maine Medical Center
- Maryland
  - Baltimore, Maryland, United States, 21204
    - Greater Baltimore Medical Center
  - Elkton, Maryland, United States, 21921
    - Union Hospital of Cecil County
  - Frederick, Maryland, United States, 21701
    - Frederick Memorial Hospital
- Michigan
  - Adrian, Michigan, United States, 49221
    - Bixby Medical Center
  - Adrian, Michigan, United States, 49221
    - Hickman Cancer Center
  - Ann Arbor, Michigan, United States, 48109
    - University of Michigan
  - Ann Arbor, Michigan, United States, 48106-0995
    - Saint Joseph Mercy Hospital
  - Ann Arbor, Michigan, United States, 48105
    - Veteran's Administration Medical Center - Ann Arbor
  - Ann Arbor, Michigan, United States, 48106
    - Michigan Cancer Research Consortium Community Clinical Oncology Program
  - Ann Arbor, Michigan, United States, 48109
    - University of Michigan University Hospital
  - Battle Creek, Michigan, United States, 49017
    - Bronson Battle Creek
  - Big Rapids, Michigan, United States, 49307
    - Spectrum Health Big Rapids Hospital
  - Dearborn, Michigan, United States, 48124
    - Oakwood Hospital and Medical Center
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital
  - Detroit, Michigan, United States, 48236
    - Saint John Hospital and Medical Center
  - Escanaba, Michigan, United States, 49431
    - Green Bay Oncology - Escanaba
  - Flint, Michigan, United States, 48502
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Grand Blanc, Michigan, United States, 48439
    - Genesys Regional Medical Center
  - Grand Rapids, Michigan, United States, 49503
    - Spectrum Health at Butterworth Campus
  - Grand Rapids, Michigan, United States, 49503
    - Mercy Health Saint Mary's
  - Grand Rapids, Michigan, United States, 49503
    - Grand Rapids Clinical Oncology Program
  - Iron Mountain, Michigan, United States, 49801
    - Green Bay Oncology - Iron Mountain
  - Jackson, Michigan, United States, 49201
    - Allegiance Health
  - Kalamazoo, Michigan, United States, 49007
    - West Michigan Cancer Center
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49001
    - Borgess Medical Center
  - Lansing, Michigan, United States, 48912
    - Sparrow Hospital
  - Livonia, Michigan, United States, 48154
    - Saint Mary Mercy Hospital
  - Monroe, Michigan, United States, 48162
    - Mercy Memorial Hospital
  - Monroe, Michigan, United States, 48162
    - Community Cancer Center of Monroe
  - Muskegon, Michigan, United States, 49444
    - Mercy Health Mercy Campus
  - Niles, Michigan, United States, 49120
    - Lakeland Community Hospital
  - Pontiac, Michigan, United States, 48341-2985
    - Saint Joseph Mercy Oakland
  - Port Huron, Michigan, United States, 48060
    - Saint Joseph Mercy Port Huron
  - Reed City, Michigan, United States, 49677
    - Spectrum Health Reed City Hospital
  - Saginaw, Michigan, United States, 48601
    - Saint Mary's of Michigan
  - Saint Joseph, Michigan, United States, 49085
    - Marie Yeager Cancer Center
  - Saint Joseph, Michigan, United States, 49085
    - Lakeland Hospital
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
  - Warren, Michigan, United States, 48093
    - Saint John Macomb-Oakland Hospital
- Minnesota
  - Bemidji, Minnesota, United States, 56601
    - Sanford Clinic North-Bemidgi
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - University of Mississippi Medical Center
  - Pascagoula, Mississippi, United States, 39581
    - Singing River Hospital
- Missouri
  - Bolivar, Missouri, United States, 65613
    - Central Care Cancer Center-Carrie J Babb Cancer Center
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Cape Girardeau, Missouri, United States, 63703
    - Southeast Cancer Center
  - Independence, Missouri, United States, 64057
    - Centerpoint Medical Center LLC
  - Jefferson City, Missouri, United States, 65109
    - Capital Region Medical Center-Goldschmidt Cancer Center
  - Joplin, Missouri, United States, 64804
    - Freeman Health System
  - Kansas City, Missouri, United States, 64116
    - North Kansas City Hospital
  - Kansas City, Missouri, United States, 64111
    - Saint Luke's Hospital of Kansas City
  - Kansas City, Missouri, United States, 64132
    - Research Medical Center
  - Kansas City, Missouri, United States, 64108
    - Truman Medical Center
  - Kansas City, Missouri, United States, 64118
    - Heartland Hematology and Oncology Associates Incorporated
  - Kansas City, Missouri, United States, 64111
    - Saint Luke's Cancer Institute
  - Kansas City, Missouri, United States, 64131
    - Kansas City Cancer Center - South
  - Kansas City, Missouri, United States, 64154
    - Kansas City Cancer Centers - North
  - Lee's Summit, Missouri, United States, 64086
    - Saint Luke's East - Lee's Summit
  - Lee's Summit, Missouri, United States, 64064
    - Kansas City Cancer Center-Lee's Summit
  - Liberty, Missouri, United States, 64068
    - Liberty Hospital
  - Rolla, Missouri, United States, 65401
    - Phelps County Regional Medical Center
  - Rolla, Missouri, United States, 65401
    - Saint John's Clinic-Rolla-Cancer and Hematology
  - Saint Joseph, Missouri, United States, 64506
    - Heartland Regional Medical Center
  - Saint Joseph, Missouri, United States, 64507
    - Saint Joseph Oncology Inc
  - Saint Louis, Missouri, United States, 63131
    - Missouri Baptist Medical Center
  - Saint Louis, Missouri, United States, 63109
    - Saint Louis Cancer and Breast Institute-South City
  - Saint Louis, Missouri, United States, 63141
    - Saint John's Mercy Medical Center
  - Saint Louis, Missouri, United States, 63141
    - Comprehensive Cancer Care PC
  - Springfield, Missouri, United States, 65807
    - CoxHealth South Hospital
  - Springfield, Missouri, United States, 65804
    - Mercy Hospital Springfield
  - Springfield, Missouri, United States, 65804
    - Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
- Montana
  - Billings, Montana, United States, 59101
    - Saint Vincent Healthcare
  - Billings, Montana, United States, 59101
    - Montana Cancer Consortium CCOP
  - Billings, Montana, United States, 59107-7000
    - Billings Clinic
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Hospital
  - Butte, Montana, United States, 59701
    - Saint James Community Hospital and Cancer Treatment Center
  - Great Falls, Montana, United States, 59405
    - Benefis Healthcare- Sletten Cancer Institute
  - Great Falls, Montana, United States, 59405
    - Big Sky Oncology
  - Helena, Montana, United States, 59601
    - Saint Peter's Community Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Missoula, Montana, United States, 59802
    - Saint Patrick Hospital - Community Hospital
  - Missoula, Montana, United States, 59802
    - Montana Cancer Specialists
- Nebraska
  - Kearney, Nebraska, United States, 68847
    - Good Samaritan Hospital
- New Hampshire
  - Concord, New Hampshire, United States, 03301
    - New Hampshire Oncology-Hematology PA
  - Hooksett, New Hampshire, United States, 03106
    - New Hampshire Oncology Hematology Associates
  - Laconia, New Hampshire, United States, 03246
    - LRGHealthcare-Lakes Region General Hospital
- New Jersey
  - Camden, New Jersey, United States, 08103
    - Cooper Hospital University Medical Center
  - Long Branch, New Jersey, United States, 07740
    - Monmouth Medical Center
  - Newark, New Jersey, United States, 07103
    - UMDNJ - New Jersey Medical School
  - Vineland, New Jersey, United States, 08360
    - Inspira Medical Center Vineland
- New Mexico
  - Albuquerque, New Mexico, United States, 87106
    - University of New Mexico
- New York
  - Elmira, New York, United States, 14905
    - Arnot Ogden Medical Center
  - Glens Falls, New York, United States, 12801
    - Glens Falls Hospital
  - New York, New York, United States, 10016
    - New York University Langone Medical Center
  - Rochester, New York, United States, 14642
    - University of Rochester
- North Carolina
  - Asheboro, North Carolina, United States, 27203
    - Randolph Hospital
  - Clinton, North Carolina, United States, 28328
    - Southeastern Medical Oncology Center-Clinton
  - Goldsboro, North Carolina, United States, 27534
    - Southeastern Medical Oncology Center-Goldsboro
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Memorial Hospital
  - Greensboro, North Carolina, United States, 27403
    - Cone Health Cancer Center
  - Hendersonville, North Carolina, United States, 28791
    - Margaret R Pardee Memorial Hospital
  - Hendersonville, North Carolina, United States, 28739
    - Hendersonville Hematology and Oncology at Pardee
  - Hendersonville, North Carolina, United States, 28792
    - Park Ridge Hospital Breast Health Center
  - Jacksonville, North Carolina, United States, 28546
    - Southeastern Medical Oncology Center-Jacksonville
  - Kinston, North Carolina, United States, 28501
    - Kinston Medical Specialists PA
  - Pinehurst, North Carolina, United States, 28374
    - FirstHealth of the Carolinas-Moore Regional Hosiptal
  - Reidsville, North Carolina, United States, 27320
    - Annie Penn Memorial Hospital
  - Rutherfordton, North Carolina, United States, 28139
    - Rutherford Hospital
  - Statesville, North Carolina, United States, 28677
    - Iredell Memorial Hospital
  - Wilson, North Carolina, United States, 27893
    - Southeastern Medical Oncology Center-Wilson
  - Winston-Salem, North Carolina, United States, 27104
    - Southeast Cancer Control Consortium CCOP
- North Dakota
  - Fargo, North Dakota, United States, 58122
    - Sanford Clinic North-Fargo
  - Fargo, North Dakota, United States, 58122
    - Sanford Medical Center-Fargo
  - Fargo, North Dakota, United States, 58122
    - Roger Maris Cancer Center
  - Grand Forks, North Dakota, United States, 58201
    - Altru Cancer Center
- Ohio
  - Akron, Ohio, United States, 44304
    - Summa Akron City Hospital/Cooper Cancer Center
  - Akron, Ohio, United States, 44307
    - Akron General Medical Center
  - Barberton, Ohio, United States, 44203
    - Summa Barberton Hospital
  - Bowling Green, Ohio, United States, 43402
    - Toledo Clinic Cancer Centers-Bowling Green
  - Cincinnati, Ohio, United States, 45267
    - University of Cincinnati
  - Cincinnati, Ohio, United States, 45242
    - Oncology Hematology Care Inc-Blue Ash
  - Cincinnati, Ohio, United States, 45211
    - Oncology Hematology Care Inc-Mercy West
  - Cincinnati, Ohio, United States, 45230
    - Oncology Hematology Care Inc - Anderson
  - Cincinnati, Ohio, United States, 45219
    - Oncology and Hematology Care Inc-Taft
  - Cincinnati, Ohio, United States, 45236
    - Oncology Hematology Care Inc - Kenwood
  - Cleveland, Ohio, United States, 44109
    - MetroHealth Medical Center
  - Columbus, Ohio, United States, 43210
    - Ohio State University Medical Center
  - Dayton, Ohio, United States, 45406
    - Good Samaritan Hospital - Dayton
  - Dayton, Ohio, United States, 45409
    - Miami Valley Hospital
  - Dayton, Ohio, United States, 45415
    - Samaritan North Health Center
  - Dayton, Ohio, United States, 45405
    - Grandview Hospital
  - Dayton, Ohio, United States, 45420
    - Dayton CCOP
  - Elyria, Ohio, United States, 44035
    - Mercy Cancer Center-Elyria
  - Elyria, Ohio, United States, 44035
    - Hematology Oncology Center Incorporated
  - Fairfield, Ohio, United States, 45014
    - Oncology Hematology Care Inc-Healthplex
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Hospital
  - Franklin, Ohio, United States, 45005-1066
    - Atrium Medical Center-Middletown Regional Hospital
  - Greenville, Ohio, United States, 45331
    - Wayne Hospital
  - Kettering, Ohio, United States, 45429
    - Kettering Medical Center
  - Lima, Ohio, United States, 45801
    - Saint Rita's Medical Center
  - Lima, Ohio, United States, 45804
    - Lima Memorial Hospital
  - Maumee, Ohio, United States, 43537
    - Toledo Clinic Cancer Centers-Maumee
  - Maumee, Ohio, United States, 43537
    - Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
  - Oregon, Ohio, United States, 43616
    - Saint Charles Hospital
  - Oregon, Ohio, United States, 43616
    - Toledo Clinic Cancer Centers-Oregon
  - Sylvania, Ohio, United States, 43560
    - Flower Hospital
  - Tiffin, Ohio, United States, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, United States, 43608
    - Saint Vincent Mercy Medical Center
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic Cancer Centers-Toledo
  - Toledo, Ohio, United States, 43614
    - University of Toledo
  - Toledo, Ohio, United States, 43617
    - Toledo Community Hospital Oncology Program CCOP
  - Toledo, Ohio, United States, 43606
    - The Toledo Hospital/Toledo Children's Hospital
  - Toledo, Ohio, United States, 43623
    - Mercy Saint Anne Hospital
  - Troy, Ohio, United States, 45373
    - Upper Valley Medical Center
  - Wauseon, Ohio, United States, 43567
    - Fulton County Health Center
  - Wright-Patterson Air Force Base, Ohio, United States, 45433-5529
    - Wright-Patterson Medical Center
  - Xenia, Ohio, United States, 45385
    - Greene Memorial Hospital
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
  - Tulsa, Oklahoma, United States, 74146
    - Tulsa Cancer Institute
  - Tulsa, Oklahoma, United States, 74136
    - Natalie Warren Bryant Cancer Center at Saint Francis
  - Tulsa, Oklahoma, United States, 74104
    - Oklahoma Oncology Inc
  - Tulsa, Oklahoma, United States, 74136
    - Warren Cancer Research Foundation
- Oregon
  - Clackamas, Oregon, United States, 97015
    - Clackamas Radiation Oncology Center
  - Milwaukie, Oregon, United States, 97222
    - Providence Milwaukie Hospital
  - Newberg, Oregon, United States, 97132
    - Providence Newberg Medical Center
  - Oregon City, Oregon, United States, 97045
    - Providence Willamette Falls Medical Center
  - Portland, Oregon, United States, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - Providence Saint Vincent Medical Center
  - Portland, Oregon, United States, 97213
    - Western Oncology Research Consortium
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18105
    - Lehigh Valley Hospital
  - Bethlehem, Pennsylvania, United States, 18017
    - Lehigh Valley Hospital - Muhlenberg
  - Lancaster, Pennsylvania, United States, 17604
    - Lancaster General Hospital
  - Philadelphia, Pennsylvania, United States, 19111
    - Fox Chase Cancer Center
  - Philadelphia, Pennsylvania, United States, 19140
    - Temple University Hospital
  - Pittsburgh, Pennsylvania, United States, 15232
    - University of Pittsburgh
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - AnMed Health Cancer Center
  - Anderson, South Carolina, United States, 29621
    - AnMed Health Hospital
  - Charleston, South Carolina, United States, 29401
    - Roper Hospital
  - Charleston, South Carolina, United States, 29403
    - Charleston Hematology Oncology Associates-Roper
  - Charleston, South Carolina, United States, 29414
    - Charleston Hematology Oncology Associates PA-St. Francis
  - Charleston, South Carolina, United States, 29414
    - Lowcountry Hematology Oncology PA-West Ashley
  - Charleston, South Carolina, United States, 29406
    - Lowcountry Hematology Oncology PA-Charleston
  - Easley, South Carolina, United States, 29640
    - Greenville Health System Cancer Institute-Easley
  - Greenville, South Carolina, United States, 29601
    - Saint Francis Hospital
  - Greenville, South Carolina, United States, 29605
    - Greenville Health System Cancer Institute-Andrews
  - Greenville, South Carolina, United States, 29605
    - Greenville Health System Cancer Institute-Faris
  - Greenville, South Carolina, United States, 29605
    - Greenville Memorial Hospital
  - Greenville, South Carolina, United States, 29605
    - Greenville Health System Cancer Institute-Butternut
  - Greenville, South Carolina, United States, 29615
    - Greenville Health System Cancer Institute/Eastside
  - Greer, South Carolina, United States, 29651
    - Gibbs Cancer Center-Pelham
  - Greer, South Carolina, United States, 29650
    - Greenville Health System Cancer Institute-Greer
  - Mount Pleasant, South Carolina, United States, 29464
    - Lowcountry Hematology Oncology PA-Mount Pleasant
  - Seneca, South Carolina, United States, 29672
    - Greenville Health System Cancer Institute-Seneca
  - Spartanburg, South Carolina, United States, 29307
    - Greenville Health System Cancer Institute-Spartanburg
  - Spartanburg, South Carolina, United States, 29303
    - Spartanburg Regional Medical Center
  - Spartanburg, South Carolina, United States, 29303
    - Upstate Carolina CCOP
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Rapid City Regional Hospital
  - Sioux Falls, South Dakota, United States, 57105
    - Avera Cancer Institute
  - Sioux Falls, South Dakota, United States, 57117-5134
    - Sanford USD Medical Center - Sioux Falls
  - Sioux Falls, South Dakota, United States, 57104
    - Sanford Cancer Center-Oncology Clinic
- Texas
  - Houston, Texas, United States, 77030
    - Baylor College of Medicine
  - Houston, Texas, United States, 77030
    - Ben Taub General Hospital
  - Houston, Texas, United States, 77030
    - Veterans Administration Medical Center
- Virginia
  - Fredericksburg, Virginia, United States, 22401
    - Fredericksburg Oncology Inc
  - Richmond, Virginia, United States, 23298
    - Virginia Commonwealth University
- Washington
  - Anacortes, Washington, United States, 98221
    - Cancer Care Center at Island Hospital
  - Auburn, Washington, United States, 98001
    - Auburn Regional Medical Center
  - Bellevue, Washington, United States, 98004
    - Overlake Hospital Medical Center
  - Bellingham, Washington, United States, 98225
    - PeaceHealth Saint Joseph Medical Center
  - Bremerton, Washington, United States, 98310
    - Harrison HealthPartners Hematology and Oncology-Bremerton
  - Burien, Washington, United States, 98166
    - Highline Medical Center-Main Campus
  - Centralia, Washington, United States, 98531
    - Providence Regional Cancer System-Centralia
  - Edmonds, Washington, United States, 98026
    - Swedish Medical Center-Edmonds
  - Everett, Washington, United States, 98201
    - Providence Regional Cancer Partnership
  - Federal Way, Washington, United States, 98003
    - Saint Francis Hospital
  - Issaquah, Washington, United States, 98029
    - Swedish Cancer Institute-Issaquah
  - Kennewick, Washington, United States, 99336
    - Columbia Basin Hematology and Oncology PLLC
  - Kirkland, Washington, United States, 98034
    - Cascade Cancer Center
  - Lacey, Washington, United States, 98503
    - Providence Regional Cancer System-Lacey
  - Lakewood, Washington, United States, 98499
    - Saint Clare Hospital
  - Longview, Washington, United States, 98632
    - Saint John Medical Center
  - Mount Vernon, Washington, United States, 98274
    - Skagit Valley Hospital
  - Olympia, Washington, United States, 98506-5166
    - Providence - Saint Peter Hospital
  - Olympia, Washington, United States, 98507
    - Capital Medical Center
  - Poulsbo, Washington, United States, 98370
    - Harrison HealthPartners Hematology and Oncology-Poulsbo
  - Puyallup, Washington, United States, 98372
    - Good Samaritan Community Hospital
  - Seattle, Washington, United States, 98195
    - University of Washington Medical Center
  - Seattle, Washington, United States, 98109
    - Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  - Seattle, Washington, United States, 98104
    - Harborview Medical Center
  - Seattle, Washington, United States, 98107
    - Swedish Medical Center-Ballard Campus
  - Seattle, Washington, United States, 98104
    - Minor and James Medical PLLC
  - Seattle, Washington, United States, 98112
    - Group Health Cooperative-Seattle
  - Seattle, Washington, United States, 98122-4307
    - Swedish Medical Center-First Hill
  - Seattle, Washington, United States, 98122
    - The Polyclinic
  - Seattle, Washington, United States, 98109
    - Group Health
  - Sedro-Woolley, Washington, United States, 98284
    - United General Hospital
  - Spokane, Washington, United States, 99218
    - Evergreen Hematology and Oncology PS
  - Spokane, Washington, United States, 99202
    - Cancer Care Northwest - Spokane South
  - Spokane, Washington, United States, 99220
    - Rockwood Clinic
  - Tacoma, Washington, United States, 98405
    - Northwest Medical Specialties PLLC
  - Tacoma, Washington, United States, 98405
    - Saint Joseph Medical Center
  - Tacoma, Washington, United States, 98405
    - Allenmore Hospital
  - Tacoma, Washington, United States, 98415
    - MultiCare Health System
  - Tacoma, Washington, United States, 98405
    - Northwest CCOP
  - Vancouver, Washington, United States, 98664
    - PeaceHealth Southwest Medical Center
  - Vancouver, Washington, United States, 98684
    - Compass Oncology Vancouver
  - Wenatchee, Washington, United States, 98801
    - Wenatchee Valley Medical Center
- Wisconsin
  - Antigo, Wisconsin, United States, 54409
    - Langlade Hospital and Cancer Center
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Clinic Cancer Center at Sacred Heart
  - Eau Claire, Wisconsin, United States, 54701
    - Sacred Heart Hospital
  - Green Bay, Wisconsin, United States, 54301
    - Saint Vincent Hospital
  - Green Bay, Wisconsin, United States, 54303
    - Green Bay Oncology Limited at Saint Mary's Hospital
  - Green Bay, Wisconsin, United States, 54303
    - Saint Mary's Hospital
  - Green Bay, Wisconsin, United States, 54301-3526
    - Green Bay Oncology at Saint Vincent Hospital
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran
  - Madison, Wisconsin, United States, 53792
    - University of Wisconsin Hospital and Clinics
  - Manitowoc, Wisconsin, United States, 54221
    - Holy Family Memorial Hospital
  - Marinette, Wisconsin, United States, 54143
    - Bay Area Medical Center
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Clinic
  - Marshfield, Wisconsin, United States, 54449
    - Saint Joseph's Hospital
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinic-Minocqua Center
  - Oconto Falls, Wisconsin, United States, 54154
    - Green Bay Oncology - Oconto Falls
  - Rhinelander, Wisconsin, United States, 54501
    - Saint Mary's Hospital
  - Rhinelander, Wisconsin, United States, 54501
    - Marshfield Clinic at James Beck Cancer Center
  - Rice Lake, Wisconsin, United States, 54868
    - Lakeview Medical Center-Marshfield Clinic
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Clinic-Rice Lake Center
  - Sheboygan, Wisconsin, United States, 53081
    - Saint Nicholas Hospital
  - Stevens Point, Wisconsin, United States, 54481
    - Saint Michael's Hospital
  - Stevens Point, Wisconsin, United States, 54481
    - Marshfield Clinic Cancer Care at Saint Michael's Hospital
  - Sturgeon Bay, Wisconsin, United States, 54235
    - Green Bay Oncology - Sturgeon Bay
  - Wausau, Wisconsin, United States, 54401
    - Aspirus Regional Cancer Center
  - Weston, Wisconsin, United States, 54476
    - Marshfield Clinic - Weston Center
  - Weston, Wisconsin, United States, 54476
    - Saint Clare's Hospital
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Marshfield Clinic - Wisconsin Rapids Center
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Riverview Hospital
- Wyoming
  - Casper, Wyoming, United States, 82609
    - Rocky Mountain Oncology
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer Center

Participation Criteria

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

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

Patients must have unresectable advanced or metastatic histologically or cytologically confirmed adenocarcinoma of the esophagus, stomach, or gastroesophageal junction (GEJ)
- Patients must not have received treatment for metastatic or unresectable disease
- Patients must not have brain metastases
Patients must have measurable and/or non-measurable disease
Patients who have had HER-2 expression testing prior to patient consent to this study must be HER-2 negative; if HER-2 expression has not been tested prior to patient consent to this study, a second specimen must be submitted for HER-2 expression; if the specimen is HER-2 positive (or if HER-2 could not be evaluated), the patient will not be randomized
Patients must have completed any prior neoadjuvant and adjuvant therapy for resectable disease at least 180 days prior to registration

PATIENT CHARACTERISTICS:

Zubrod performance status of 0-1
Hemoglobin ≥ 9 g/dL
Absolute neutrophil count (ANC) ≥ 1,500/mcL
Platelets ≥ 100,000/mcL
Total bilirubin ≤ 1.5 mg/dL regardless of whether patients have liver involvement secondary to tumor
AST and ALT both ≤ 3 times institutional upper limit of normal (IULN) unless the liver is involved with tumor, in which case both AST and ALT must be ≤ 5 times IULN
Serum creatinine < 1.5 mg/dL within 28 days prior to registration AND/OR calculated creatinine clearance > 60 mL/min
Patients must not have motor or sensory neuropathy > Grade 1 using CTCAE version 4.0
Patients must not be pregnant or nursing; women and men of reproductive potential must have agreed to use an effective contraceptive method
No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
All palliative radiation therapy alone must be completed at least 14 days prior to registration
Patient must have no plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any other type of therapy for treatment of cancer while on this protocol treatment

Study Plan

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

How is the study designed?

Design Details

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

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I FOLFOX regimen: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.	Drug: FOLFOX regimen Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium. Drug: fluorouracil 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle. Other Names: 5-FU 5-fluorouracil NSC-19893 Drug: leucovorin calcium 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle. Other Names: NSC-3590 Drug: oxaliplatin 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle. Other Names: Eloxatin NSC-266046
Experimental: Arm II Patients receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Drug: docetaxel 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle. Other Names: Taxotere RP56976 NSC-628503 Drug: irinotecan hydrochloride 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle. Other Names: CPT-11 NSC-616348

Participant Group / Arm

Intervention / Treatment

Experimental: Arm I

FOLFOX regimen: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Drug: FOLFOX regimen

Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium.

Drug: fluorouracil

400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle.

Other Names:

5-FU
5-fluorouracil
NSC-19893

Drug: leucovorin calcium

400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.

Other Names:

NSC-3590

Drug: oxaliplatin

85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.

Other Names:

Eloxatin
NSC-266046

Experimental: Arm II

Patients receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: docetaxel

30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.

Other Names:

Taxotere
RP56976
NSC-628503

Drug: irinotecan hydrochloride

65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.

Other Names:

CPT-11
NSC-616348

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS) in High-ERCC1 Patients Time Frame: Up to 3 years after registration	Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first.	Up to 3 years after registration
PFS in Low-ERCC1 Participants Time Frame: Up to 3 years after registration	Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first.	Up to 3 years after registration
Overall Survival (OS) Time Frame: Up to 3 years after registration	OS is the length of time between protocol registration and patient death	Up to 3 years after registration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Time Frame: Duration of treatment and follow up until death or 3 years post registration	Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.	Duration of treatment and follow up until death or 3 years post registration
Overall Response Rate (ORR) Time Frame: Up to 3 years after registration	ORR (complete response, unconfirmed complete response, partial response, unconfirmed partial response) in patients with measurable disease were assessed in each arm and compared between arms using Chi-squared test. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.	Up to 3 years after registration
PFS Variation by ERCC1 Time Frame: up to 3 years after registration	Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first. Participants were divided into subgroups according to ERCC1 quartiles to assess whether the differences in PFS between the two treatment arms varied by ERCC1 levels.	up to 3 years after registration

Collaborators and Investigators

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

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Syma Iqbal, MD, University of Southern California

Study record dates

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

Study Major Dates

Study Start (Actual)

February 1, 2012

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

September 19, 2019

Study Registration Dates

First Submitted

December 22, 2011

First Submitted That Met QC Criteria

December 22, 2011

First Posted (Estimate)

December 23, 2011

Study Record Updates

Last Update Posted (Actual)

November 7, 2019

Last Update Submitted That Met QC Criteria

October 25, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

S1201 (Other Identifier: SWOG)
U10CA032102 (U.S. NIH Grant/Contract)
NCI-2012-00096 (Other Identifier: CTRP)

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

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Active, not recruiting

Early Recovery After Surgery Protocol in Improving Quality of Life in Participants With Stage 0-IIIC Gastric Cancer Undergoing Surgery

Gastric Adenocarcinoma | Clinical Stage III Gastric Cancer AJCC v8 | Clinical Stage 0 Gastric Cancer AJCC v8 | Clinical Stage I Gastric Cancer AJCC v8 | Clinical Stage II Gastric Cancer AJCC v8 | Clinical Stage IIA Gastric Cancer AJCC v8 | Clinical Stage IIB Gastric Cancer AJCC v8 | Pathologic Stage... and other conditions

United States
City of Hope Medical Center

Completed

64Cu DOTA-Trastuzumab PET/CT in Studying Patients With Gastric Cancer

Adenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric Cancer and other conditions

United States
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Active, not recruiting

Short-Course Chemoradiotherapy Followed by Chemotherapy for the Treatment of Resectable Gastric Adenocarcinoma

Gastric Adenocarcinoma | Clinical Stage III Gastric Cancer AJCC v8 | Clinical Stage I Gastric Cancer AJCC v8 | Clinical Stage IIA Gastric Cancer AJCC v8 | Clinical Stage IVA Gastric Cancer AJCC v8 | Pathologic Stage IB Gastric Cancer AJCC v8 | Pathologic Stage II Gastric Cancer AJCC v8 | Pathologic... and other conditions

United States
National Cancer Institute (NCI)

Completed

Irinotecan and Cisplatin in Treating Patients Who Are Undergoing Surgery For Locally Advanced Cancer of the Stomach or Gastroesophageal Junction

Gastric Adenocarcinoma | Stage IV Gastric Cancer | Stage II Gastric Cancer | Stage III Gastric Cancer

United States
Ukrainian Society of Clinical Oncology

Recruiting

Investigation of Impact of Indocyanine Green on Volume of Lymphadenectomy in Resectable Gastric Cancer (ICGastr)

Gastric Cancer | Gastrectomy for Gastric Cancer | Gastric Cancer Stage III | Gastric Cancer Stage II

Ukraine
Lin Liu

Recruiting

The Correlation Between Blood Concentration of Sintilimab and Efficacy and Adverse Reactions in Patients with Advanced Gastric Cancer

Gastric Carcinoma | Gastric Neoplasm | Gastric Cancer Adenocarcinoma Metastatic | Gastric (cardia, Body) Cancer

China
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)

Active, not recruiting

Pembrolizumab, Capecitabine, and Radiation Therapy in Treating Patients With Mismatch-Repair Deficient and Epstein-Barr Virus Positive Gastric Cancer

Gastric Adenocarcinoma | Epstein-Barr Virus Positive | Mismatch Repair Protein Deficiency | Stage IB Gastric Cancer AJCC v7 | Stage II Gastric Cancer AJCC v7 | Stage IIA Gastric Cancer AJCC v7 | Stage IIB Gastric Cancer AJCC v7 | Stage III Gastric Cancer AJCC v7 | Stage IIIA Gastric Cancer AJCC v7 | Stage... and other conditions

United States
Mayo Clinic
National Cancer Institute (NCI)

Completed

Pembrolizumab, Combination Chemotherapy, and Radiation Therapy Before Surgery in Treating Adult Patients With Locally Advanced Gastroesophageal Junction or Gastric Cardia Cancer That Can Be Removed by Surgery

Gastroesophageal Junction Adenocarcinoma | Gastric Cardia Adenocarcinoma | Stage IB Gastric Cancer AJCC v7 | Stage II Gastric Cancer AJCC v7 | Stage IIA Gastric Cancer AJCC v7 | Stage IIB Gastric Cancer AJCC v7 | Stage IIIA Gastric Cancer AJCC v7 | Stage IIIB Gastric Cancer AJCC v7

United States
Shanghai Changzheng Hospital

Not yet recruiting

HIPEC Priming Followed by Serplulimab Plus SOX/XELOX in Locally Advanced Gastric Cancer

Gastric Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | Locally Advanced Gastric Cancer

Clinical Trials on FOLFOX regimen

Fox Chase Cancer Center

Active, not recruiting

Organ Preservation in Early Rectal Cancer Patients

Rectal Cancer

United States
UNICANCER

Recruiting

Dose Individualization of Chemotherapy in Patients With Gastrointestinal Cancers Lacking a Specific Liver Enzyme (FUDOSE)

Colorectal Cancer | Digestive Cancer

France
Washington University School of Medicine

Completed

Non-Operative Management and Early Response Assessment in Rectal Cancer (NOM-ERA)

Adenocarcinoma of the Lower Rectum

United States
UNICANCER
Summit Therapeutics; Cancer Research UK & UCL Cancer Trials Centre; Belgian Group...

Recruiting

Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients (SEVILLA)

Biliary Tract Cancer

France, United Kingdom
Biotheus Inc.

Active, not recruiting

PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular Carcinoma

Hepatocellular Carcinoma

China
Tang-Du Hospital

Recruiting

Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gastric Cancer

Gastric Cancer

China
Weill Medical College of Cornell University
Arcus Biosciences, Inc.

Recruiting

A Phase I-II Study to Test the Safety and Efficacy of PD1 (AB122) and Adenosine Receptor (AB928) Antagonists With Chemotherapy After Short-Course Radiation for Rectal Cancer. (PANTHER)

Rectal Cancer

United States
Jiangsu Province Hospital of Traditional Chinese...

Unknown

Estimate the Efficacy of HD6610 Granule for Oxaliplatin-induced Peripheral Neuropathy

Peripheral Neuropathy

China
Ohio State University
Osato Research Institute

Completed

Nutritional Regulation of Wound Inflammation: Part II (FPPT2DM-II)

Diabetes

United States
Sixth Affiliated Hospital, Sun Yat-sen University

Recruiting

ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer

Colorectal Cancer | Chemotherapy Effect | Liver Metastases | Circulating Tumor Cell

China

S1201: Combination Chemo for Patients W/Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer

A Randomized Phase II Pilot Study Prospectively Evaluating Treatment for Patients Based on ERCC1(Excision Repair Cross-Complementing 1) for Advanced/Metastatic Esophageal, Gastric or Gastroesophageal Junction (GEJ) Cancer

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Clinical Trials on Gastric Cancer

Clinical Trials on FOLFOX regimen

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