- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00045162
S0124: Cisplatin Combined With Irinotecan or Etoposide For Extensive-Stage Small Cell Lung Cancer
Randomized Phase III Trial of Cisplatin and Irinotecan (NSC-616348) Versus Cisplatin and Etoposide in Patients With Extensive Stage Small Cell Lung Cancer (E-SCLC)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether cisplatin combined with irinotecan is more effective than cisplatin combined with etoposide in treating extensive-stage small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin combined with either irinotecan or etoposide in treating patients who have extensive-stage small cell lung cancer.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
- Compare the survival of patients with extensive stage small cell lung cancer treated with cisplatin and irinotecan vs cisplatin and etoposide.
- Compare the objective response rate and progression-free survival of patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
- Determine the association between UGT1A1 polymorphisms and irinotecan-associated toxic effects in these patients.
- Determine the association between ERCC-1 and XRCC-1 polymorphisms and non-response of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of metastatic sites (single vs multiple), lactic dehydrogenase (no greater than upper limit of normal (ULN) vs greater than ULN), and weight loss in the past 6 months (5% or less vs more than 5%). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1. Courses repeat every 4 weeks.
- Arm II: Patients receive etoposide IV over 30-60 minutes on days 1-3 and cisplatin IV over 30-60 minutes on day 1. Courses repeat every 3 weeks.
Treatment in both arms continues for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 620 patients (310 per treatment arm) will be accrued for this study within 4 years.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre at Pasqua Hospital
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
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Alabama
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Anniston, Alabama, Forenede Stater, 36202
- Northeast Alabama Regional Medical Center
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Huntsville, Alabama, Forenede Stater, 35801
- Huntsville Hospital
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Mobile, Alabama, Forenede Stater, 36652-2144
- Mobile Infirmary Medical Center
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Opelika, Alabama, Forenede Stater, 36801-5452
- East Alabama Medical Center
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Alaska
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Anchorage, Alaska, Forenede Stater, 99508
- Alaska Regional Hospital Cancer Center
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Arizona
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Scottsdale, Arizona, Forenede Stater, 85259-5499
- Mayo Clinic Scottsdale
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Tucson, Arizona, Forenede Stater, 85724-5024
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Fort Smith, Arkansas, Forenede Stater, 72903
- Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
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Little Rock, Arkansas, Forenede Stater, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Burbank, California, Forenede Stater, 91505
- Providence Saint Joseph Medical Center - Burbank
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Concord, California, Forenede Stater, 94524-4110
- Cancer Care Center at John Muir Health - Concord Campus
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Fremont, California, Forenede Stater, 94538
- Washington Township Hospital
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Fresno, California, Forenede Stater, 93720
- California Cancer Center - Woodward Park Office
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Los Angeles, California, Forenede Stater, 90089-9181
- USC/Norris Comprehensive Cancer Center and Hospital
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Palm Springs, California, Forenede Stater, 92262
- Desert Regional Medical Center Comprehensive Cancer Center
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Redding, California, Forenede Stater, 96001
- Shasta Regional Medical Center
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Roseville, California, Forenede Stater, 95661
- Sutter Cancer Center at Roseville Medical Center
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Sacramento, California, Forenede Stater, 95816
- Sutter Cancer center
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Sacramento, California, Forenede Stater, 95817
- University of California Davis Cancer Center
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Santa Rosa, California, Forenede Stater, 95405
- CCOP - Santa Rosa Memorial Hospital
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Walnut Creek, California, Forenede Stater, 94598
- John Muir/Mt. Diablo Comprehensive Cancer Center
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80909
- Memorial Hospital
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Connecticut
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Norwich, Connecticut, Forenede Stater, 06360
- Eastern Connecticut Hematology and Oncology Associates
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Florida
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Daytona Beach, Florida, Forenede Stater, 32115
- Halifax Medical Center - Daytona Beach
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Fort Lauderdale, Florida, Forenede Stater, 33316
- Broward General Medical Center Cancer Center
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Pensacola, Florida, Forenede Stater, 32514
- West Florida Cancer Institute at West Florida Hospital - Pensacola
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Georgia
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Atlanta, Georgia, Forenede Stater, 30309
- Piedmont Hospital
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Atlanta, Georgia, Forenede Stater, 30342-1611
- Northside Hospital Cancer Center
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Atlanta, Georgia, Forenede Stater, 30342-1701
- Saint Joseph's Hospital of Atlanta
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Atlanta, Georgia, Forenede Stater, 30342
- CCOP - Atlanta Regional
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Augusta, Georgia, Forenede Stater, 30901
- Augusta Oncology Associates - Walton Way
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Austell, Georgia, Forenede Stater, 30106
- WellStar Cobb Hospital
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Decatur, Georgia, Forenede Stater, 30033
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
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Lawrenceville, Georgia, Forenede Stater, 30045
- Gwinnett Medical Center
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Marietta, Georgia, Forenede Stater, 30060
- Kennestone Cancer Center at Wellstar Kennestone Hospital
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Riverdale, Georgia, Forenede Stater, 30274-2600
- Southern Regional Medical Center
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Savannah, Georgia, Forenede Stater, 31403-3089
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Valdosta, Georgia, Forenede Stater, 31603
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96859
- Tripler Army Medical Center
-
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Idaho
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Idaho Falls, Idaho, Forenede Stater, 83404
- Hematology Oncology Associates of Eastern Idaho
-
-
Illinois
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Alton, Illinois, Forenede Stater, 62002
- Saint Anthony's Hospital at Saint Anthony's Health Center
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Aurora, Illinois, Forenede Stater, 60507
- Rush-Copley Cancer Care Center
-
Decatur, Illinois, Forenede Stater, 62526
- Decatur Memorial Hospital Cancer Care Institute
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Elmhurst, Illinois, Forenede Stater, 60126
- Elmhurst Memorial Hospital
-
Hines, Illinois, Forenede Stater, 60141
- Veterans Affairs Medical Center - Hines
-
Joliet, Illinois, Forenede Stater, 60435
- Joliet Oncology-Hematology Associates, Limited - West
-
La Grange, Illinois, Forenede Stater, 60525
- La Grange Memorial Hospital
-
Maywood, Illinois, Forenede Stater, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Moline, Illinois, Forenede Stater, 61265
-
Moline, Illinois, Forenede Stater, 61265
- Trinity Medical Center - East
-
Mount Vernon, Illinois, Forenede Stater, 62864
- Good Samaritan Regional Health Center
-
River Forest, Illinois, Forenede Stater, 60305
- West Suburban Center for Cancer Care
-
Rockford, Illinois, Forenede Stater, 61104-2315
- Swedish-American Regional Cancer Center
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Springfield, Illinois, Forenede Stater, 62781-0001
- Regional Cancer Center at Memorial Medical Center
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Urbana, Illinois, Forenede Stater, 61801
- Carle Cancer Center at Carle Foundation Hospital
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Urbana, Illinois, Forenede Stater, 61801
- CCOP - Carle Cancer Center
-
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Indiana
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Beech Grove, Indiana, Forenede Stater, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
-
Elkhart, Indiana, Forenede Stater, 46515
- Elkhart General Hospital
-
Kokomo, Indiana, Forenede Stater, 46904
- Howard Community Hospital at Howard Regional Health System
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La Porte, Indiana, Forenede Stater, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Michigan City, Indiana, Forenede Stater, 46360
- Saint Anthony Memorial Health Centers
-
Richmond, Indiana, Forenede Stater, 47374
- Reid Hospital & Health Care Services, Incorporated
-
South Bend, Indiana, Forenede Stater, 46601
- Memorial Hospital of South Bend
-
South Bend, Indiana, Forenede Stater, 46601
- CCOP - Northern Indiana CR Consortium
-
South Bend, Indiana, Forenede Stater, 46617
- Saint Joseph Regional Medical Center
-
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Iowa
-
Bettendorf, Iowa, Forenede Stater, 52722
-
Bettendorf, Iowa, Forenede Stater, 52722
- Hematology Oncology Associates of the Quad Cities
-
Cedar Rapids, Iowa, Forenede Stater, 52402
- St. Luke's Hospital
-
Cedar Rapids, Iowa, Forenede Stater, 52403
- Cedar Rapids Oncology Associates
-
Cedar Rapids, Iowa, Forenede Stater, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
-
Council Bluffs, Iowa, Forenede Stater, 51503
- Heartland Oncology & Hematology
-
Davenport, Iowa, Forenede Stater, 52804
- Genesis Medical Center - West Campus
-
Davenport, Iowa, Forenede Stater, 52803
- Genesis Regional Cancer Center at Genesis Medical Center
-
Des Moines, Iowa, Forenede Stater, 50309
- CCOP - Iowa Oncology Research Association
-
Des Moines, Iowa, Forenede Stater, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
-
Des Moines, Iowa, Forenede Stater, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
-
Des Moines, Iowa, Forenede Stater, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
-
Des Moines, Iowa, Forenede Stater, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Forenede Stater, 50307
- Mercy Capitol Hospital
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Des Moines, Iowa, Forenede Stater, 50316-2301
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Mason City, Iowa, Forenede Stater, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
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Ottumwa, Iowa, Forenede Stater, 52501
- McCreery Cancer Center at Ottumwa Regional
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Sioux City, Iowa, Forenede Stater, 51101
- Siouxland Regional Cancer Center
-
Sioux City, Iowa, Forenede Stater, 51101
- Siouxland Hematology-Oncology Associates, LLP
-
Sioux City, Iowa, Forenede Stater, 51104
- St. Luke's Regional Medical Center
-
Sioux City, Iowa, Forenede Stater, 51104
- Mercy Medical Center - Sioux City
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Waterloo, Iowa, Forenede Stater, 50702
- Covenant Cancer Treatment Center
-
Waterloo, Iowa, Forenede Stater, 50702
- Cedar Valley Medical Specialists, PC - West Ridgeway Avenue
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Kansas
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Chanute, Kansas, Forenede Stater, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Forenede Stater, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Forenede Stater, 67042
- Cancer Center of Kansas, PA - El Dorado
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Kansas City, Kansas, Forenede Stater, 64128
- Veterans Affairs Medical Center - Kansas City
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Kingman, Kansas, Forenede Stater, 67068
- Cancer Center of Kansas, PA - Kingman
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Liberal, Kansas, Forenede Stater, 67901
- Southwest Medical Center
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Newton, Kansas, Forenede Stater, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Forenede Stater, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Forenede Stater, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Forenede Stater, 67042
- Cancer Center of Kansas, PA - Salina
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Salina, Kansas, Forenede Stater, 67401
- Tammy Walker Cancer Center at Salina Regional Health Center
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Topeka, Kansas, Forenede Stater, 66604
- Stormont-Vail Cancer Center
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Wellington, Kansas, Forenede Stater, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Forenede Stater, 67203
- Associates in Womens Health, PA - North Review
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Wichita, Kansas, Forenede Stater, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Forenede Stater, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Forenede Stater, 67214
- CCOP - Wichita
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Wichita, Kansas, Forenede Stater, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Winfield, Kansas, Forenede Stater, 67156
- Cancer Center of Kansas, PA - Winfield
-
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Kentucky
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Madisonville, Kentucky, Forenede Stater, 42431
- Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
-
-
Louisiana
-
Alexandria, Louisiana, Forenede Stater, 71315-3198
- Tulane Cancer Center
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Monroe, Louisiana, Forenede Stater, 71210
- Louisiana State University Health Sciences Center - Monroe
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Shreveport, Louisiana, Forenede Stater, 71130-3932
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
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Shreveport, Louisiana, Forenede Stater, 71101
- Veterans Affairs Medical Center - Shreveport
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Shreveport, Louisiana, Forenede Stater, 71101
- Christus Schumpert Cancer Treatment Center
-
-
Maine
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Bangor, Maine, Forenede Stater, 04401
- CancerCare of Maine at Eastern Maine Medial Center
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Waterville, Maine, Forenede Stater, 04901
- MaineGeneral Medical Center - Waterville Campus
-
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Massachusetts
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Attleboro, Massachusetts, Forenede Stater, 02703
- Sturdy Memorial Hospital
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Boston, Massachusetts, Forenede Stater, 02118
- Cancer Research Center at Boston Medical Center
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Gloucester, Massachusetts, Forenede Stater, 01930
- Addison Gilbert Hospital
-
Worcester, Massachusetts, Forenede Stater, 01655
- UMASS Memorial Cancer Center - University Campus
-
-
Michigan
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Adrian, Michigan, Forenede Stater, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, Forenede Stater, 48106-0995
- Saint Joseph Mercy Cancer Center
-
Ann Arbor, Michigan, Forenede Stater, 48106
- CCOP - Michigan Cancer Research Consortium
-
Battle Creek, Michigan, Forenede Stater, 49017
- Battle Creek Health System Cancer Care Center
-
Big Rapids, Michigan, Forenede Stater, 49307
- Mecosta County Medical Center
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Detroit, Michigan, Forenede Stater, 48202
- Josephine Ford Cancer Center at Henry Ford Hospital
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Escanaba, Michigan, Forenede Stater, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, Forenede Stater, 48503
- Hurley Medical Center
-
Flint, Michigan, Forenede Stater, 48503
- Genesys Hurley Cancer Institute
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Grand Rapids, Michigan, Forenede Stater, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, Forenede Stater, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Grand Rapids, Michigan, Forenede Stater, 49506
- Metro Health Hospital
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Grand Rapids, Michigan, Forenede Stater, 49503
- Spectrum Health Hospital - Butterworth Campus
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Grosse Pointe Woods, Michigan, Forenede Stater, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Holland, Michigan, Forenede Stater, 49423
- Holland Community Hospital
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Iron Mountain, Michigan, Forenede Stater, 49801
- Green Bay Oncology, Limited - Iron Mountain
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Jackson, Michigan, Forenede Stater, 49201
- Foote Hospital
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Kalamazoo, Michigan, Forenede Stater, 49007
- Bronson Methodist Hospital
-
Kalamazoo, Michigan, Forenede Stater, 49001
- Borgess Medical Center
-
Kalamazoo, Michigan, Forenede Stater, 49007-3731
- West Michigan Cancer Center
-
Lansing, Michigan, Forenede Stater, 48909
- Sparrow Regional Cancer Center
-
Marquette, Michigan, Forenede Stater, 49855
- Upper Michigan Cancer Center at Marquette General Hospital
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Midland, Michigan, Forenede Stater, 48670
- MidMichigan Medical Center - Midland
-
Monroe, Michigan, Forenede Stater, 48162
- Community Cancer Center of Monroe
-
Monroe, Michigan, Forenede Stater, 48162
- Mercy Memorial Hospital System
-
Mount Clemens, Michigan, Forenede Stater, 48043
- Ted B. Wahby Cancer Center at Mount Clemens General Hospital
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Muskegon, Michigan, Forenede Stater, 49442
- Hackley Hospital
-
Petoskey, Michigan, Forenede Stater, 49770
- Northern Michigan Hospital
-
Port Huron, Michigan, Forenede Stater, 48060
- Mercy Regional Cancer Center at Mercy Hospital
-
Saginaw, Michigan, Forenede Stater, 48601
- Seton Cancer Institute - Saginaw
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Saint Joseph, Michigan, Forenede Stater, 49085
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
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Traverse City, Michigan, Forenede Stater, 49684
- Munson Medical Center
-
Warren, Michigan, Forenede Stater, 48093
- St. John Macomb Hospital
-
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Minnesota
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Alexandria, Minnesota, Forenede Stater, 56308
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Bemidji, Minnesota, Forenede Stater, 56601
- MeritCare Clinic - Bemidji
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Burnsville, Minnesota, Forenede Stater, 55337
- Fairview Ridges Hospital
-
Coon Rapids, Minnesota, Forenede Stater, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Forenede Stater, 55805
- CCOP - Duluth
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Duluth, Minnesota, Forenede Stater, 55805
- St. Mary's - Duluth Clinic Cancer Center
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Duluth, Minnesota, Forenede Stater, 55805
- Miller-Dwan Medical Center
-
Duluth, Minnesota, Forenede Stater, 55805
- Cancer Care Center at St. Luke's Hospital
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Edina, Minnesota, Forenede Stater, 55435
- Fairview Southdale Hospital
-
Fergus Falls, Minnesota, Forenede Stater, 56537
-
Fridley, Minnesota, Forenede Stater, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Forenede Stater, 55350
- Hutchinson Area Health Care
-
Litchfield, Minnesota, Forenede Stater, 55355
- Meeker County Memorial Hospital
-
Mankato, Minnesota, Forenede Stater, 56002
- Immanuel St. Joseph's Clinic
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Maplewood, Minnesota, Forenede Stater, 55109
- HealthEast Cancer Care at St. John's Hospital
-
Maplewood, Minnesota, Forenede Stater, 55109
- Minnesota Oncology Hematology, PA at Maplewood Cancer Center
-
Minneapolis, Minnesota, Forenede Stater, 55415
- Hennepin County Medical Center - Minneapolis
-
Minneapolis, Minnesota, Forenede Stater, 55407
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
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Montevideo, Minnesota, Forenede Stater, 56265
- Chippewa County - Montevideo Hospital
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Robbinsdale, Minnesota, Forenede Stater, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Cancer Center
-
Saint Cloud, Minnesota, Forenede Stater, 56303
- CentraCare Clinic - River Campus
-
Saint Cloud, Minnesota, Forenede Stater, 56303
- Coborn Cancer Center
-
Saint Louis Park, Minnesota, Forenede Stater, 55416
- CCOP - Metro-Minnesota
-
Saint Louis Park, Minnesota, Forenede Stater, 55416
- Park Nicollet Health Services
-
Saint Paul, Minnesota, Forenede Stater, 55102
- St. Joseph's Hospital
-
Saint Paul, Minnesota, Forenede Stater, 55102
- United Hospital
-
Saint Paul, Minnesota, Forenede Stater, 55101
- Regions Hospital Cancer Care Center
-
Shakopee, Minnesota, Forenede Stater, 55379
- Saint Francis Cancer Center
-
Waconia, Minnesota, Forenede Stater, 55387
- Ridgeview Medical Center
-
Willmar, Minnesota, Forenede Stater, 56201
- Willmar Cancer Center at Rice Memorial Hospital
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Woodbury, Minnesota, Forenede Stater, 55125
- Woodwinds Health Campus
-
Woodbury, Minnesota, Forenede Stater, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Mississippi
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Jackson, Mississippi, Forenede Stater, 39216
- University of Mississippi Medical Center
-
-
Missouri
-
Cape Girardeau, Missouri, Forenede Stater, 63701
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
-
Cape Girardeau, Missouri, Forenede Stater, 63701
- Saint Francis Medical Center
-
Columbia, Missouri, Forenede Stater, 65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
-
Columbia, Missouri, Forenede Stater, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
-
Jefferson City, Missouri, Forenede Stater, 65101
- Capital Region Cancer Center
-
Joplin, Missouri, Forenede Stater, 64804
- Freeman Cancer Institute at Freeman Health System
-
Kansas City, Missouri, Forenede Stater, 64131
- CCOP - Kansas City
-
Saint Louis, Missouri, Forenede Stater, 63131
- Missouri Baptist Cancer Center
-
Saint Louis, Missouri, Forenede Stater, 63141
- CCOP - St. Louis-Cape Girardeau
-
Saint Louis, Missouri, Forenede Stater, 63141
- David C. Pratt Cancer Center at St. John's Mercy
-
Saint Louis, Missouri, Forenede Stater, 63141
- Arch Medical Services, Incorporated at Center for Cancer Care Research
-
Springfield, Missouri, Forenede Stater, 65802
- CCOP - Cancer Research for the Ozarks
-
Springfield, Missouri, Forenede Stater, 65804
- St. John's Regional Health Center
-
Springfield, Missouri, Forenede Stater, 65807
- Hulston Cancer Center at Cox Medical Center South
-
-
Montana
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Billings, Montana, Forenede Stater, 59101
- CCOP - Montana Cancer Consortium
-
Billings, Montana, Forenede Stater, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
-
Billings, Montana, Forenede Stater, 59101
- Northern Rockies Radiation Oncology Center
-
Billings, Montana, Forenede Stater, 59101
- St. Vincent Healthcare
-
Billings, Montana, Forenede Stater, 59107-5100
- Billings Clinic Cancer Center
-
Billings, Montana, Forenede Stater, 59107-7000
- Deaconess Billings Clinic - Downtown
-
Bozeman, Montana, Forenede Stater, 59715
- Bozeman Deaconess Cancer Center
-
Butte, Montana, Forenede Stater, 59701
- St. James Community Hospital
-
Great Falls, Montana, Forenede Stater, 59405
- Great Falls Clinic
-
Great Falls, Montana, Forenede Stater, 59405
-
Great Falls, Montana, Forenede Stater, 59405
- Big Sky Oncology
-
Great Falls, Montana, Forenede Stater, 59405
- Sletten Regional Cancer Institute at Benefis Healthcare
-
Helena, Montana, Forenede Stater, 59601
- St. Peter's Hospital
-
Kalispell, Montana, Forenede Stater, 59901
- Kalispell Regional Medical Center
-
Kalispell, Montana, Forenede Stater, 59901
- Glacier Oncology, PLLC
-
Kalispell, Montana, Forenede Stater, 59901
- Kalispell Medical Oncology
-
Missoula, Montana, Forenede Stater, 59801
- Community Medical Center
-
Missoula, Montana, Forenede Stater, 59804
- Guardian Oncology and Center for Wellness
-
Missoula, Montana, Forenede Stater, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
-
Missoula, Montana, Forenede Stater, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
-
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Nebraska
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Kearney, Nebraska, Forenede Stater, 68848-1990
- Good Samaritan Cancer Center at Good Samaritan Hospital
-
Lincoln, Nebraska, Forenede Stater, 68510
- Cancer Resource Center - Lincoln
-
Omaha, Nebraska, Forenede Stater, 68106
- CCOP - Missouri Valley Cancer Consortium
-
Omaha, Nebraska, Forenede Stater, 68122
- Immanuel Medical Center
-
Omaha, Nebraska, Forenede Stater, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
-
Omaha, Nebraska, Forenede Stater, 68131-2197
- Creighton University Medical Center
-
Omaha, Nebraska, Forenede Stater, 68114
- Methodist Cancer Center at Methodist Hospital - Omaha
-
-
Nevada
-
Las Vegas, Nevada, Forenede Stater, 89102
- University Medical Center of Southern Nevada
-
Las Vegas, Nevada, Forenede Stater, 89106
- CCOP - Nevada Cancer Research Foundation
-
-
New Jersey
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Flemington, New Jersey, Forenede Stater, 08822
- Hunterdon Regional Cancer Center at Hunterdon Medical Center
-
Morristown, New Jersey, Forenede Stater, 07962
- Carol G. Simon Cancer Center at Morristown Memorial Hospital
-
Neptune, New Jersey, Forenede Stater, 07754-0397
- Jersey Shore Cancer Center at Jersey Shore University Medical Center
-
Summit, New Jersey, Forenede Stater, 07902
- Overlook Hospital
-
-
New York
-
Bronx, New York, Forenede Stater, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
-
Buffalo, New York, Forenede Stater, 14215
- Veterans Affairs Medical Center - Buffalo
-
Clifton Springs, New York, Forenede Stater, 14432
- Finger Lakes Hematology and Oncology
-
Glens Falls, New York, Forenede Stater, 12801
- Adirondack Cancer Care - Glens Falls
-
Manhasset, New York, Forenede Stater, 11030
- CCOP - North Shore University Hospital
-
Manhasset, New York, Forenede Stater, 11030
- Don Monti Comprehensive Cancer Center at North Shore University Hospital
-
Middletown, New York, Forenede Stater, 10940-4199
- Tucker Center for Cancer Care at Orange Regional Medical Center
-
Mineola, New York, Forenede Stater, 11501
- Winthrop University Hospital
-
New Hyde Park, New York, Forenede Stater, 11042
- Long Island Jewish Medical Center
-
Rochester, New York, Forenede Stater, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
-
Rochester, New York, Forenede Stater, 14623
- Interlakes Oncology/Hematology PC
-
Syracuse, New York, Forenede Stater, 13210
- SUNY Upstate Medical University Hospital
-
-
North Carolina
-
Goldsboro, North Carolina, Forenede Stater, 27534
- Wayne Memorial Hospital, Incorporated
-
Kinston, North Carolina, Forenede Stater, 28501
- Lenoir Memorial Cancer Center
-
Rutherfordton, North Carolina, Forenede Stater, 28139
- Rutherford Hospital
-
Wilmington, North Carolina, Forenede Stater, 28401
- Zimmer Cancer Center at New Hanover Regional Medical Center
-
-
North Dakota
-
Bismarck, North Dakota, Forenede Stater, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, Forenede Stater, 58501
- Medcenter One Hospital Cancer Care Center
-
Bismarck, North Dakota, Forenede Stater, 58501
- Mid Dakota Clinic, PC
-
Bismarck, North Dakota, Forenede Stater, 58502
- St. Alexius Medical Center Cancer Center
-
Fargo, North Dakota, Forenede Stater, 58122
- CCOP - MeritCare Hospital
-
Fargo, North Dakota, Forenede Stater, 58122
- MeritCare Broadway
-
Fargo, North Dakota, Forenede Stater, 58103
- Dakota Cancer Institute at Dakota Clinic - South University
-
-
Ohio
-
Akron, Ohio, Forenede Stater, 44307
- McDowell Cancer Center at Akron General Medical Center
-
Bowling Green, Ohio, Forenede Stater, 43402
- Wood County Oncology Center
-
Canton, Ohio, Forenede Stater, 44708
- Mercy Cancer Center at Mercy Medical Center
-
Chillicothe, Ohio, Forenede Stater, 45601
- Adena Regional Medical Center
-
Cincinnati, Ohio, Forenede Stater, 45267
- Charles M. Barrett Cancer Center at University Hospital
-
Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Taussig Cancer Center
-
Cleveland, Ohio, Forenede Stater, 44109
- MetroHealth's Cancer Care Center at MetroHealth Medical Center
-
Columbus, Ohio, Forenede Stater, 43214-3998
- Riverside Methodist Hospital Cancer Care
-
Columbus, Ohio, Forenede Stater, 43222
- Mount Carmel Health - West Hospital
-
Columbus, Ohio, Forenede Stater, 43215
- CCOP - Columbus
-
Columbus, Ohio, Forenede Stater, 43228
- Doctors Hospital at Ohio Health
-
Columbus, Ohio, Forenede Stater, 43215
- Grant Riverside Cancer Services
-
Dayton, Ohio, Forenede Stater, 45428
- Veterans Affairs Medical Center - Dayton
-
Dayton, Ohio, Forenede Stater, 45405
- Grandview Hospital
-
Dayton, Ohio, Forenede Stater, 45406
- Good Samaritan Hospital
-
Dayton, Ohio, Forenede Stater, 45415
- Samaritan North Cancer Care Center
-
Dayton, Ohio, Forenede Stater, 45429
- CCOP - Dayton
-
Delaware, Ohio, Forenede Stater, 43015
- Grady Memorial Hospital
-
Findlay, Ohio, Forenede Stater, 45840
- Blanchard Valley Medical Associates
-
Fremont, Ohio, Forenede Stater, 43420
- Fremont Memorial Hospital
-
Independence, Ohio, Forenede Stater, 44131
- Community Oncology Group at Cleveland Clinic Cancer Center
-
Kenton, Ohio, Forenede Stater, 43326
- Kenton Oncology, Incorporated
-
Kettering, Ohio, Forenede Stater, 45429
- Charles F. Kettering Memorial Hospital
-
Lancaster, Ohio, Forenede Stater, 43130
- Fairfield Medical Center
-
Lima, Ohio, Forenede Stater, 45804
- Lima Memorial Hospital
-
Lima, Ohio, Forenede Stater, 45801
- St. Rita's Medical Center
-
Mansfield, Ohio, Forenede Stater, 44903
- MedCentral - Mansfield Hospital
-
Marietta, Ohio, Forenede Stater, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
-
Maumee, Ohio, Forenede Stater, 43537
- St. Luke's Hospital
-
Maumee, Ohio, Forenede Stater, 43623
- Northwest Ohio Oncology Center
-
Middletown, Ohio, Forenede Stater, 45044
- Middletown Regional Hospital
-
Newark, Ohio, Forenede Stater, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
-
Oregon, Ohio, Forenede Stater, 43616
- St. Charles Mercy Hospital
-
Oregon, Ohio, Forenede Stater, 43616
- Toledo Clinic - Oregon
-
Sandusky, Ohio, Forenede Stater, 44870
- Firelands Regional Medical Center
-
Sandusky, Ohio, Forenede Stater, 44870
- North Coast Cancer Care, Incorporated
-
Springfield, Ohio, Forenede Stater, 45505
- Community Hospital of Springfield and Clark County
-
Springfield, Ohio, Forenede Stater, 45504
- Mercy Medical Center
-
Sylvania, Ohio, Forenede Stater, 43560
- Flower Hospital Cancer Center
-
Toledo, Ohio, Forenede Stater, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, Forenede Stater, 43606
- Toledo Hospital
-
Toledo, Ohio, Forenede Stater, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, Forenede Stater, 43617
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, Forenede Stater, 43623
- Toledo Clinic, Incorporated - Main Clinic
-
Troy, Ohio, Forenede Stater, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Wauseon, Ohio, Forenede Stater, 43567
- Fulton County Health Center
-
Westerville, Ohio, Forenede Stater, 43081
- Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
-
Wooster, Ohio, Forenede Stater, 44691
- Cleveland Clinic - Wooster
-
Xenia, Ohio, Forenede Stater, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
-
Youngstown, Ohio, Forenede Stater, 44501
- Tod Children's Hospital - Forum Health
-
Zanesville, Ohio, Forenede Stater, 43701
- Genesis - Good Samaritan Hospital
-
-
Oregon
-
Klamath Falls, Oregon, Forenede Stater, 97601
- Merle West Medical Center Cancer Treatment Center
-
Portland, Oregon, Forenede Stater, 97207
- Veterans Affairs Medical Center - Portland
-
Portland, Oregon, Forenede Stater, 97239-3098
- Oregon Health & Science University Cancer Institute
-
Portland, Oregon, Forenede Stater, 97232
- Kaiser Permanente Health Care - Portland
-
Salem, Oregon, Forenede Stater, 97309-5014
- Salem Hospital Regional Cancer Care Services
-
-
Pennsylvania
-
Allentown, Pennsylvania, Forenede Stater, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
-
Danville, Pennsylvania, Forenede Stater, 17822-0001
- Geisinger Medical Center
-
DuBois, Pennsylvania, Forenede Stater, 15801
- Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center
-
Easton, Pennsylvania, Forenede Stater, 18042
- Easton Regional Cancer Center at Easton Hospital
-
Harrisburg, Pennsylvania, Forenede Stater, 17105
- PinnacleHealth Regional Cancer Center at Polyclinic Hospital
-
Lancaster, Pennsylvania, Forenede Stater, 17604
- Lancaster General Hospital
-
Langhorne, Pennsylvania, Forenede Stater, 19047
- St. Mary Regional Cancer Center
-
Pittsburgh, Pennsylvania, Forenede Stater, 15212
- Allegheny Cancer Center at Allegheny General Hospital
-
Scranton, Pennsylvania, Forenede Stater, 18501
- Mercy Hospital Cancer Center - Scranton
-
Scranton, Pennsylvania, Forenede Stater, 18510
- Hematology and Oncology Associates of Northeastern Pennsylvania
-
State College, Pennsylvania, Forenede Stater, 16801
- Geisinger Medical Group - Scenery Park
-
Wilkes-Barre, Pennsylvania, Forenede Stater, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
-
-
South Carolina
-
Anderson, South Carolina, Forenede Stater, 29621
- AnMed Cancer Center
-
Charleston, South Carolina, Forenede Stater, 29425
- Hollings Cancer Center at Medical University of South Carolina
-
Greenville, South Carolina, Forenede Stater, 29615
- CCOP - Greenville
-
Greenville, South Carolina, Forenede Stater, 29601
- Bon Secours St. Francis Health System
-
Spartanburg, South Carolina, Forenede Stater, 29303
- CCOP - Upstate Carolina
-
Spartanburg, South Carolina, Forenede Stater, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
-
-
South Dakota
-
Rapid City, South Dakota, Forenede Stater, 57701
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, Forenede Stater, 57105
- Avera Cancer Institute
-
Sioux Falls, South Dakota, Forenede Stater, 57117-5039
- Sioux Valley Hospital and University of South Dakota Medical Center
-
Sioux Falls, South Dakota, Forenede Stater, 57105
- Medical X-Ray Center, PC
-
-
Tennessee
-
Knoxville, Tennessee, Forenede Stater, 37916
- Thompson Cancer Survival Center
-
Knoxville, Tennessee, Forenede Stater, 37920-6999
- U.T. Cancer Institute at University of Tennessee Medical Center
-
Memphis, Tennessee, Forenede Stater, 38104
- University of Tennessee Cancer Institute - Medical Center
-
-
Texas
-
Dallas, Texas, Forenede Stater, 75230
- Medical City Dallas Hospital
-
Fort Sam Houston, Texas, Forenede Stater, 78234
- Brooke Army Medical Center
-
Houston, Texas, Forenede Stater, 77030
- Ben Taub General Hospital
-
Houston, Texas, Forenede Stater, 77030
- Methodist Hospital
-
Houston, Texas, Forenede Stater, 77030
- Veterans Affairs Medical Center - Houston
-
Houston, Texas, Forenede Stater, 77030
- Baylor University Medical Center - Houston
-
Houston, Texas, Forenede Stater, 77030
- St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
-
Lackland Air Force Base, Texas, Forenede Stater, 78236
- Wilford Hall Medical Center
-
Lubbock, Texas, Forenede Stater, 79415-3364
- UMC Southwest Cancer and Research Center
-
San Antonio, Texas, Forenede Stater, 78229
- Cancer Therapy and Research Center
-
San Antonio, Texas, Forenede Stater, 78209
- Veterans Affairs Medical Center - San Antonio (Murphy)
-
San Antonio, Texas, Forenede Stater, 78229-3900
- University of Texas Health Science Center at San Antonio
-
San Antonio, Texas, Forenede Stater, 78229
- University Hospital - San Antonio
-
Temple, Texas, Forenede Stater, 76508
- CCOP - Scott and White Hospital
-
-
Utah
-
American Fork, Utah, Forenede Stater, 84003
- American Fork Hospital
-
Logan, Utah, Forenede Stater, 84321
- Logan Regional Hospital
-
Murray, Utah, Forenede Stater, 84107
- Cottonwood Hospital Medical Center
-
Ogden, Utah, Forenede Stater, 84403
- McKay-Dee Hospital Center
-
Provo, Utah, Forenede Stater, 84604
- Utah Valley Regional Medical Center - Provo
-
Saint George, Utah, Forenede Stater, 84770
- Dixie Regional Medical Center - East Campus
-
Salt Lake City, Utah, Forenede Stater, 84112
- Huntsman Cancer Institute at University of Utah
-
Salt Lake City, Utah, Forenede Stater, 84106
- Utah Cancer Specialists at UCS Cancer Center
-
Salt Lake City, Utah, Forenede Stater, 84143
- Latter Day Saints Hospital
-
-
Virginia
-
Charlottesville, Virginia, Forenede Stater, 22901
- Martha Jefferson Hospital Cancer Care Center
-
Danville, Virginia, Forenede Stater, 24541
- Danville Regional Medical Center
-
Lynchburg, Virginia, Forenede Stater, 24501
- Lynchburg Hematology-Oncology Clinic
-
Newport News, Virginia, Forenede Stater, 23601
- Peninsula Cancer Institute - Newport News Office
-
Richmond, Virginia, Forenede Stater, 23249
- Veterans Affairs Medical Center - Richmond
-
-
Washington
-
Auburn, Washington, Forenede Stater, 98002
- Auburn Regional Center for Cancer Care
-
Bellingham, Washington, Forenede Stater, 98225
- St. Joseph Cancer Center
-
Bremerton, Washington, Forenede Stater, 98310
- Olympic Hematology and Oncology
-
Centralia, Washington, Forenede Stater, 98531-9027
- Providence Centralia Hospital Regional Cancer Center
-
Federal Way, Washington, Forenede Stater, 98003
- St. Francis Hospital
-
Mount Vernon, Washington, Forenede Stater, 98273
- Skagit Valley Hospital Cancer Care Center
-
Olympia, Washington, Forenede Stater, 98506-5166
- Providence St. Peter Hospital Regional Cancer Center
-
Puyallup, Washington, Forenede Stater, 98372
- Good Samaritan Cancer Center
-
Seattle, Washington, Forenede Stater, 98104
- Harborview Medical Center
-
Seattle, Washington, Forenede Stater, 98104
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, Forenede Stater, 98104
- Minor and James Medical, PLLC
-
Seattle, Washington, Forenede Stater, 98112
- Group Health Central Hospital
-
Seattle, Washington, Forenede Stater, 98122-4307
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
-
Seattle, Washington, Forenede Stater, 98122
- Polyclinic First Hill
-
Seattle, Washington, Forenede Stater, 98195-6043
- University Cancer Center at University of Washington Medical Center
-
Spokane, Washington, Forenede Stater, 99202
- Cancer Care Northwest - Spokane South
-
Spokane, Washington, Forenede Stater, 99204-2967
- Rockwood Clinic Cancer Treatment Center
-
Spokane, Washington, Forenede Stater, 99204
- Providence Cancer Center at Sacred Heart Medical Center
-
Spokane, Washington, Forenede Stater, 99207
- Providence Cancer Center at Holy Family Hospital
-
Tacoma, Washington, Forenede Stater, 98405
- Allenmore Hospital
-
Tacoma, Washington, Forenede Stater, 98405
- CCOP - Northwest
-
Tacoma, Washington, Forenede Stater, 98405
- MultiCare Regional Cancer Center at Tacoma General Hospital
-
Tacoma, Washington, Forenede Stater, 98499
- St. Clare Hospital
-
Tacoma, Washington, Forenede Stater, 98405-3004
- St. Joseph Medical Center at Franciscan Health System
-
Wenatchee, Washington, Forenede Stater, 98801-2028
- Wenatchee Valley Medical Center
-
-
Wisconsin
-
Appleton, Wisconsin, Forenede Stater, 54911-3496
- Fox Valley Hematology and Oncology - East Grant Street
-
Green Bay, Wisconsin, Forenede Stater, 54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, Forenede Stater, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay, Wisconsin, Forenede Stater, 54303
- St. Mary's Hospital Medical Center - Green Bay
-
Green Bay, Wisconsin, Forenede Stater, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital
-
Janesville, Wisconsin, Forenede Stater, 53547
- Mercy Regional Cancer Center
-
La Crosse, Wisconsin, Forenede Stater, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
-
Manitowoc, Wisconsin, Forenede Stater, 54221-1450
- Holy Family Memorial Medical Center Cancer Care Center
-
Marinette, Wisconsin, Forenede Stater, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
-
Marshfield, Wisconsin, Forenede Stater, 54449
- Marshfield Clinic - Marshfield Center
-
Oconto Falls, Wisconsin, Forenede Stater, 54154
- Green Bay Oncology, Limited - Oconto Falls
-
Racine, Wisconsin, Forenede Stater, 53405
- All Saints Cancer Center at Wheaton Franciscan Healthcare
-
Rice Lake, Wisconsin, Forenede Stater, 54868
- Marshfield Clinic - Indianhead Center
-
Sturgeon Bay, Wisconsin, Forenede Stater, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
-
Wausau, Wisconsin, Forenede Stater, 54401
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
-
-
Wyoming
-
Sheridan, Wyoming, Forenede Stater, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed extensive stage small cell lung cancer (SCLC)
- Measurable or evaluable disease by CT scan, MRI, x-ray, physical exam, or nuclear exam
- Brain metastases allowed if previously treated with radiotherapy and/or surgery and are neurologically stable (i.e., no progressing symptoms and off steroids and anticonvulsants)
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,000/mm^3
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST or ALT no greater than 2.5 times ULN
Renal
- Creatinine normal
- Creatinine clearance at least 50 mL/min
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- HIV negative
- No concurrent AIDS-related illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior biologic therapy for SCLC
- No filgrastim (G-CSF) within 24 hours of chemotherapy
Chemotherapy
- No prior systemic chemotherapy for SCLC
Endocrine therapy
- See Disease Characteristics
Radiotherapy
- See Disease Characteristics
- At least 21 days since prior brain radiotherapy and recovered
- No other prior radiotherapy for SCLC
Surgery
- See Disease Characteristics
- At least 21 days since prior thoracic or other major surgery and recovered
Other
- No concurrent enzyme inducing antiepileptic drugs (phenytoin, phenobarbital, oxcarboxepine, or carbamazepine)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 2
|
Arm 1: 60 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles Arm 2: 80 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles
100 mg/m2 IV (over 30-60 min) on Days 1 , 2 & 3. Q 3 weeks x 4 Cycles
|
|
Aktiv komparator: 1
|
Arm 1: 60 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles Arm 2: 80 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles
60 mg/m2 IV (over 90 min)on Days 1, 8 & 15.
Q 4 weeks x 4 Cycles
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival
Tidsramme: Weekly while on treatment, then every 3 months for first year, then every 6 months unitl a maximum of 3 years from enrollment.
|
Overall survival was defined as the duration between the date of randomization( enrollment) and the date of death due to any cause.
Patients last known to be alive were censored at the date of last contact.
|
Weekly while on treatment, then every 3 months for first year, then every 6 months unitl a maximum of 3 years from enrollment.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-free Survival
Tidsramme: Every 6 weeks until disease progression or a maximum of 3 years from the date of enrollment.
|
Progression-Free Survival was defined as the duration from the date of randomization (enrollment) until the date of documentation of progression as defined by RECIST (a 20% increase over nadir in the sum of longest diameters of target lesions, clear progression of a non-target lesion in the opinion of the treating investigator, appearance of new lesions, or symptomatic deterioration) or death due to any cause.
Patients last known to be alive and without evidence of progression were censored at the date of last contact.
|
Every 6 weeks until disease progression or a maximum of 3 years from the date of enrollment.
|
|
Confirmed and Unconfirmed Complete and Partial Responses.
Tidsramme: Every 6 weeks while on protocol treatment for a maximum of 12 weeks
|
Patients underwent chest CT/MRI every 6 weeks while on treatment and tumor response was evaluated by RECIST in the subset of patients with at least one target lesion at baseline.
A target lesion was defined as a lesion with a longest diameter of at least 2 cm ( or at least 1 cm if by spiral CT).
A complete response (CR) was defined as the disappearance of all disease, including non-target lesions.
A partial response (PR) was defined as a 30% or greater decrease in the sum of the longest diameters.
Confirmation of a CR or PR was defined as a second determination of CR or PR at least 4 weeks after the first determination.
|
Every 6 weeks while on protocol treatment for a maximum of 12 weeks
|
|
Number of Patients With a Given Type and Grade of Adverse Event.
Tidsramme: Every 4 weeks while subject on protocol treatment for a maximum of 12 weeks.
|
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Only patients who received protocol treatment and were assessed for adverse events are included.
|
Every 4 weeks while subject on protocol treatment for a maximum of 12 weeks.
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Primo N. Lara, MD, University of California, Davis
- Ledende efterforsker: Ronald B. Natale, MD, Cedars-Sinai Medical Center
- Ledende efterforsker: David R. Gandara, MD, University of California, Davis
- Ledende efterforsker: James R. Jett, MD, Mayo Clinic
- Ledende efterforsker: Jane Carleton, MD, Don Monti Comprehensive Cancer Center at North Shore University Hospital
Publikationer og nyttige links
Generelle publikationer
- Lara PN Jr, Chansky K, Shibata T, Fukuda H, Tamura T, Crowley J, Redman MW, Natale R, Saijo N, Gandara DR. Common arm comparative outcomes analysis of phase 3 trials of cisplatin + irinotecan versus cisplatin + etoposide in extensive stage small cell lung cancer: final patient-level results from Japan Clinical Oncology Group 9511 and Southwest Oncology Group 0124. Cancer. 2010 Dec 15;116(24):5710-5. doi: 10.1002/cncr.25532. Epub 2010 Aug 24.
- Lara PN Jr, Natale R, Crowley J, Lenz HJ, Redman MW, Carleton JE, Jett J, Langer CJ, Kuebler JP, Dakhil SR, Chansky K, Gandara DR. Phase III trial of irinotecan/cisplatin compared with etoposide/cisplatin in extensive-stage small-cell lung cancer: clinical and pharmacogenomic results from SWOG S0124. J Clin Oncol. 2009 May 20;27(15):2530-5. doi: 10.1200/JCO.2008.20.1061. Epub 2009 Apr 6.
- Natale RB, Lara PN, Chansky K, et al.: S0124: A randomized phase III trial comparing irinotecan/cisplatin (IP) with etoposide/cisplatin (EP) in patients (pts) with previously untreated extensive stage small cell lung cancer (E-SCLC). [Abstract] J Clin Oncol 26 (Suppl 15): A-7512, 2008.
- Hanna N, Bunn PA Jr, Langer C, Einhorn L, Guthrie T Jr, Beck T, Ansari R, Ellis P, Byrne M, Morrison M, Hariharan S, Wang B, Sandler A. Randomized phase III trial comparing irinotecan/cisplatin with etoposide/cisplatin in patients with previously untreated extensive-stage disease small-cell lung cancer. J Clin Oncol. 2006 May 1;24(13):2038-43. doi: 10.1200/JCO.2005.04.8595.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Småcellet lungekarcinom
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Antineoplastiske midler, fytogene
- Topoisomerase II-hæmmere
- Topoisomerasehæmmere
- Topoisomerase I-hæmmere
- Etoposid
- Irinotecan
Andre undersøgelses-id-numre
- CDR0000256908
- U10CA032102 (U.S. NIH-bevilling/kontrakt)
- S0124 (Anden identifikator: CALGB)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Lungekræft
-
Seoul National University HospitalAfsluttet
-
Seoul National University HospitalAfsluttet
-
Chinese Chronic Respiratory Disease Research NetworkRekruttering
-
Mansoura UniversityAfsluttetOne Lung VentilationEgypten
-
Dokuz Eylul UniversityAfsluttetOne Lung VentilationKalkun
-
Yonsei UniversityAfsluttetOne Lung VentilationKorea, Republikken
-
Sichuan UniversityWest China HospitalMidlertidigt ikke tilgængeligOne Lung Ventilation
-
Luca BrazziA.O.U. Città della Salute e della Scienza - Molinette HospitalIkke rekrutterer endnuIntubationskomplikation | One Lung Ventilation
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Ankara Ataturk Sanatorium Training and Research...Ikke rekrutterer endnuOne-lung Ventilation (OLV)Tyrkiet (Türkiye)
-
Joseph D. TobiasAfsluttetOne-lung Ventilation (OLV)Forenede Stater
Kliniske forsøg med cisplatin
-
West China Second University HospitalRekrutteringNeoadjuverende kemoterapi | Epitelkarcinom, ovarieKina
-
Insmed IncorporatedAfsluttetOsteosarkom MetastatiskForenede Stater
-
Privo TechnologiesNational Cancer Institute (NCI)AfsluttetOralt planocellulært karcinomForenede Stater
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London Health Sciences Centre Research Institute...RekrutteringLokalt avanceret hoved- og halspladecellekarcinomCanada
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Taiho Oncology, Inc.Quintiles, Inc.AfsluttetMavekræftForenede Stater, Canada
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Cedars-Sinai Medical CenterAktiv, ikke rekrutterendeHPV-positivt orofaryngealt planocellulært karcinomForenede Stater
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Sun Yat-sen UniversityAktiv, ikke rekrutterendeNasopharyngealt karcinomKina
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Fujian Cancer HospitalIkke rekrutterer endnuNasopharyngealt karcinomKina
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Bangabandhu Sheikh Mujib Medical University, Dhaka...Afsluttet
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Taiho Pharmaceutical Co., Ltd.AfsluttetLivmoderhalskræftJapan, Korea, Republikken, Taiwan