S0124: Cisplatin Combined With Irinotecan or Etoposide For Extensive-Stage Small Cell Lung Cancer
3 juillet 2018 mis à jour par: Southwest Oncology Group
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
671
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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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, États-Unis, 36202
- Northeast Alabama Regional Medical Center
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Huntsville, Alabama, États-Unis, 35801
- Huntsville Hospital
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Mobile, Alabama, États-Unis, 36652-2144
- Mobile Infirmary Medical Center
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Opelika, Alabama, États-Unis, 36801-5452
- East Alabama Medical Center
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Alaska
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Anchorage, Alaska, États-Unis, 99508
- Alaska Regional Hospital Cancer Center
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Arizona
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Scottsdale, Arizona, États-Unis, 85259-5499
- Mayo Clinic Scottsdale
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Tucson, Arizona, États-Unis, 85724-5024
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Fort Smith, Arkansas, États-Unis, 72903
- Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
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Little Rock, Arkansas, États-Unis, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Burbank, California, États-Unis, 91505
- Providence Saint Joseph Medical Center - Burbank
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Concord, California, États-Unis, 94524-4110
- Cancer Care Center at John Muir Health - Concord Campus
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Fremont, California, États-Unis, 94538
- Washington Township Hospital
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Fresno, California, États-Unis, 93720
- California Cancer Center - Woodward Park Office
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Los Angeles, California, États-Unis, 90089-9181
- USC/Norris Comprehensive Cancer Center and Hospital
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Palm Springs, California, États-Unis, 92262
- Desert Regional Medical Center Comprehensive Cancer Center
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Redding, California, États-Unis, 96001
- Shasta Regional Medical Center
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Roseville, California, États-Unis, 95661
- Sutter Cancer Center at Roseville Medical Center
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Sacramento, California, États-Unis, 95816
- Sutter Cancer Center
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Sacramento, California, États-Unis, 95817
- University of California Davis Cancer Center
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Santa Rosa, California, États-Unis, 95405
- CCOP - Santa Rosa Memorial Hospital
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Walnut Creek, California, États-Unis, 94598
- John Muir/Mt. Diablo Comprehensive Cancer Center
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Colorado
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Colorado Springs, Colorado, États-Unis, 80909
- Memorial Hospital
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Connecticut
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Norwich, Connecticut, États-Unis, 06360
- Eastern Connecticut Hematology and Oncology Associates
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Florida
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Daytona Beach, Florida, États-Unis, 32115
- Halifax Medical Center - Daytona Beach
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Fort Lauderdale, Florida, États-Unis, 33316
- Broward General Medical Center Cancer Center
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Pensacola, Florida, États-Unis, 32514
- West Florida Cancer Institute at West Florida Hospital - Pensacola
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Georgia
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Atlanta, Georgia, États-Unis, 30309
- Piedmont Hospital
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Atlanta, Georgia, États-Unis, 30342-1611
- Northside Hospital Cancer Center
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Atlanta, Georgia, États-Unis, 30342-1701
- Saint Joseph's Hospital of Atlanta
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Atlanta, Georgia, États-Unis, 30342
- CCOP - Atlanta Regional
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Augusta, Georgia, États-Unis, 30901
- Augusta Oncology Associates - Walton Way
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Austell, Georgia, États-Unis, 30106
- WellStar Cobb Hospital
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Decatur, Georgia, États-Unis, 30033
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
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Lawrenceville, Georgia, États-Unis, 30045
- Gwinnett Medical Center
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Marietta, Georgia, États-Unis, 30060
- Kennestone Cancer Center at Wellstar Kennestone Hospital
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Riverdale, Georgia, États-Unis, 30274-2600
- Southern Regional Medical Center
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Savannah, Georgia, États-Unis, 31403-3089
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Valdosta, Georgia, États-Unis, 31603
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
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Hawaii
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Honolulu, Hawaii, États-Unis, 96859
- Tripler Army Medical Center
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Idaho
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Idaho Falls, Idaho, États-Unis, 83404
- Hematology Oncology Associates of Eastern Idaho
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Illinois
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Alton, Illinois, États-Unis, 62002
- Saint Anthony's Hospital at Saint Anthony's Health Center
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Aurora, Illinois, États-Unis, 60507
- Rush-Copley Cancer Care Center
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Decatur, Illinois, États-Unis, 62526
- Decatur Memorial Hospital Cancer Care Institute
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Elmhurst, Illinois, États-Unis, 60126
- Elmhurst Memorial Hospital
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Hines, Illinois, États-Unis, 60141
- Veterans Affairs Medical Center - Hines
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Joliet, Illinois, États-Unis, 60435
- Joliet Oncology-Hematology Associates, Limited - West
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La Grange, Illinois, États-Unis, 60525
- La Grange Memorial Hospital
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Maywood, Illinois, États-Unis, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Moline, Illinois, États-Unis, 61265
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Moline, Illinois, États-Unis, 61265
- Trinity Medical Center - East
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Mount Vernon, Illinois, États-Unis, 62864
- Good Samaritan Regional Health Center
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River Forest, Illinois, États-Unis, 60305
- West Suburban Center for Cancer Care
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Rockford, Illinois, États-Unis, 61104-2315
- Swedish-American Regional Cancer Center
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Springfield, Illinois, États-Unis, 62781-0001
- Regional Cancer Center at Memorial Medical Center
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Urbana, Illinois, États-Unis, 61801
- Carle Cancer Center at Carle Foundation Hospital
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Urbana, Illinois, États-Unis, 61801
- CCOP - Carle Cancer Center
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Indiana
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Beech Grove, Indiana, États-Unis, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Elkhart, Indiana, États-Unis, 46515
- Elkhart General Hospital
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Kokomo, Indiana, États-Unis, 46904
- Howard Community Hospital at Howard Regional Health System
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La Porte, Indiana, États-Unis, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Michigan City, Indiana, États-Unis, 46360
- Saint Anthony Memorial Health Centers
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Richmond, Indiana, États-Unis, 47374
- Reid Hospital & Health Care Services, Incorporated
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South Bend, Indiana, États-Unis, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, États-Unis, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, États-Unis, 46617
- Saint Joseph Regional Medical Center
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Iowa
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Bettendorf, Iowa, États-Unis, 52722
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Bettendorf, Iowa, États-Unis, 52722
- Hematology Oncology Associates of the Quad Cities
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Cedar Rapids, Iowa, États-Unis, 52402
- St. Luke's Hospital
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Cedar Rapids, Iowa, États-Unis, 52403
- Cedar Rapids Oncology Associates
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Cedar Rapids, Iowa, États-Unis, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Council Bluffs, Iowa, États-Unis, 51503
- Heartland Oncology & Hematology
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Davenport, Iowa, États-Unis, 52804
- Genesis Medical Center - West Campus
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Davenport, Iowa, États-Unis, 52803
- Genesis Regional Cancer Center at Genesis Medical Center
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Des Moines, Iowa, États-Unis, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, États-Unis, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, États-Unis, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, États-Unis, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, États-Unis, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, États-Unis, 50307
- Mercy Capitol Hospital
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Des Moines, Iowa, États-Unis, 50316-2301
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Mason City, Iowa, États-Unis, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
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Ottumwa, Iowa, États-Unis, 52501
- McCreery Cancer Center at Ottumwa Regional
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Sioux City, Iowa, États-Unis, 51101
- Siouxland Regional Cancer Center
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Sioux City, Iowa, États-Unis, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, États-Unis, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, États-Unis, 51104
- Mercy Medical Center - Sioux City
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Waterloo, Iowa, États-Unis, 50702
- Covenant Cancer Treatment Center
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Waterloo, Iowa, États-Unis, 50702
- Cedar Valley Medical Specialists, PC - West Ridgeway Avenue
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Kansas
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Chanute, Kansas, États-Unis, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, États-Unis, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, États-Unis, 67042
- Cancer Center of Kansas, PA - El Dorado
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Kansas City, Kansas, États-Unis, 64128
- Veterans Affairs Medical Center - Kansas City
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Kingman, Kansas, États-Unis, 67068
- Cancer Center of Kansas, PA - Kingman
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Liberal, Kansas, États-Unis, 67901
- Southwest Medical Center
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Newton, Kansas, États-Unis, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, États-Unis, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, États-Unis, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, États-Unis, 67042
- Cancer Center of Kansas, PA - Salina
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Salina, Kansas, États-Unis, 67401
- Tammy Walker Cancer Center at Salina Regional Health Center
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Topeka, Kansas, États-Unis, 66604
- Stormont-Vail Cancer Center
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Wellington, Kansas, États-Unis, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, États-Unis, 67203
- Associates in Womens Health, PA - North Review
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Wichita, Kansas, États-Unis, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, États-Unis, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, États-Unis, 67214
- CCOP - Wichita
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Wichita, Kansas, États-Unis, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Winfield, Kansas, États-Unis, 67156
- Cancer Center of Kansas, PA - Winfield
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Kentucky
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Madisonville, Kentucky, États-Unis, 42431
- Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
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Louisiana
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Alexandria, Louisiana, États-Unis, 71315-3198
- Tulane Cancer Center
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Monroe, Louisiana, États-Unis, 71210
- Louisiana State University Health Sciences Center - Monroe
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Shreveport, Louisiana, États-Unis, 71130-3932
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
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Shreveport, Louisiana, États-Unis, 71101
- Veterans Affairs Medical Center - Shreveport
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Shreveport, Louisiana, États-Unis, 71101
- Christus Schumpert Cancer Treatment Center
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Maine
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Bangor, Maine, États-Unis, 04401
- CancerCare of Maine at Eastern Maine Medial Center
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Waterville, Maine, États-Unis, 04901
- MaineGeneral Medical Center - Waterville Campus
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Massachusetts
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Attleboro, Massachusetts, États-Unis, 02703
- Sturdy Memorial Hospital
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Boston, Massachusetts, États-Unis, 02118
- Cancer Research Center at Boston Medical Center
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Gloucester, Massachusetts, États-Unis, 01930
- Addison Gilbert Hospital
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Worcester, Massachusetts, États-Unis, 01655
- UMASS Memorial Cancer Center - University Campus
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Michigan
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Adrian, Michigan, États-Unis, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, États-Unis, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, États-Unis, 48106
- CCOP - Michigan Cancer Research Consortium
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Battle Creek, Michigan, États-Unis, 49017
- Battle Creek Health System Cancer Care Center
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Big Rapids, Michigan, États-Unis, 49307
- Mecosta County Medical Center
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Detroit, Michigan, États-Unis, 48202
- Josephine Ford Cancer Center at Henry Ford Hospital
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Escanaba, Michigan, États-Unis, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, États-Unis, 48503
- Hurley Medical Center
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Flint, Michigan, États-Unis, 48503
- Genesys Hurley Cancer Institute
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Grand Rapids, Michigan, États-Unis, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, États-Unis, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Grand Rapids, Michigan, États-Unis, 49506
- Metro Health Hospital
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Grand Rapids, Michigan, États-Unis, 49503
- Spectrum Health Hospital - Butterworth Campus
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Grosse Pointe Woods, Michigan, États-Unis, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Holland, Michigan, États-Unis, 49423
- Holland Community Hospital
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Iron Mountain, Michigan, États-Unis, 49801
- Green Bay Oncology, Limited - Iron Mountain
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Jackson, Michigan, États-Unis, 49201
- Foote Hospital
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Kalamazoo, Michigan, États-Unis, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, États-Unis, 49001
- Borgess Medical Center
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Kalamazoo, Michigan, États-Unis, 49007-3731
- West Michigan Cancer Center
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Lansing, Michigan, États-Unis, 48909
- Sparrow Regional Cancer Center
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Marquette, Michigan, États-Unis, 49855
- Upper Michigan Cancer Center at Marquette General Hospital
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Midland, Michigan, États-Unis, 48670
- MidMichigan Medical Center - Midland
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Monroe, Michigan, États-Unis, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, États-Unis, 48162
- Mercy Memorial Hospital System
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Mount Clemens, Michigan, États-Unis, 48043
- Ted B. Wahby Cancer Center at Mount Clemens General Hospital
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Muskegon, Michigan, États-Unis, 49442
- Hackley Hospital
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Petoskey, Michigan, États-Unis, 49770
- Northern Michigan Hospital
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Port Huron, Michigan, États-Unis, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Saginaw, Michigan, États-Unis, 48601
- Seton Cancer Institute - Saginaw
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Saint Joseph, Michigan, États-Unis, 49085
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
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Traverse City, Michigan, États-Unis, 49684
- Munson Medical Center
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Warren, Michigan, États-Unis, 48093
- St. John Macomb Hospital
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Minnesota
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Alexandria, Minnesota, États-Unis, 56308
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Bemidji, Minnesota, États-Unis, 56601
- MeritCare Clinic - Bemidji
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Burnsville, Minnesota, États-Unis, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, États-Unis, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, États-Unis, 55805
- CCOP - Duluth
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Duluth, Minnesota, États-Unis, 55805
- St. Mary's - Duluth Clinic Cancer Center
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Duluth, Minnesota, États-Unis, 55805
- Miller-Dwan Medical Center
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Duluth, Minnesota, États-Unis, 55805
- Cancer Care Center at St. Luke's Hospital
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Edina, Minnesota, États-Unis, 55435
- Fairview Southdale Hospital
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Fergus Falls, Minnesota, États-Unis, 56537
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Fridley, Minnesota, États-Unis, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, États-Unis, 55350
- Hutchinson Area Health Care
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Litchfield, Minnesota, États-Unis, 55355
- Meeker County Memorial Hospital
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Mankato, Minnesota, États-Unis, 56002
- Immanuel St. Joseph's Clinic
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Maplewood, Minnesota, États-Unis, 55109
- HealthEast Cancer Care at St. John's Hospital
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Maplewood, Minnesota, États-Unis, 55109
- Minnesota Oncology Hematology, PA at Maplewood Cancer Center
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Minneapolis, Minnesota, États-Unis, 55415
- Hennepin County Medical Center - Minneapolis
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Minneapolis, Minnesota, États-Unis, 55407
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
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Montevideo, Minnesota, États-Unis, 56265
- Chippewa County - Montevideo Hospital
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Robbinsdale, Minnesota, États-Unis, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
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Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, États-Unis, 56303
- CentraCare Clinic - River Campus
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Saint Cloud, Minnesota, États-Unis, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, États-Unis, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, États-Unis, 55416
- Park Nicollet Health Services
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Saint Paul, Minnesota, États-Unis, 55102
- St. Joseph's Hospital
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Saint Paul, Minnesota, États-Unis, 55102
- United Hospital
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Saint Paul, Minnesota, États-Unis, 55101
- Regions Hospital Cancer Care Center
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Shakopee, Minnesota, États-Unis, 55379
- Saint Francis Cancer Center
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Waconia, Minnesota, États-Unis, 55387
- Ridgeview Medical Center
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Willmar, Minnesota, États-Unis, 56201
- Willmar Cancer Center at Rice Memorial Hospital
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Woodbury, Minnesota, États-Unis, 55125
- Woodwinds Health Campus
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Woodbury, Minnesota, États-Unis, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Mississippi
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Jackson, Mississippi, États-Unis, 39216
- University of Mississippi Medical Center
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Missouri
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Cape Girardeau, Missouri, États-Unis, 63701
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
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Cape Girardeau, Missouri, États-Unis, 63701
- Saint Francis Medical Center
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Columbia, Missouri, États-Unis, 65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
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Columbia, Missouri, États-Unis, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Jefferson City, Missouri, États-Unis, 65101
- Capital Region Cancer Center
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Joplin, Missouri, États-Unis, 64804
- Freeman Cancer Institute at Freeman Health System
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Kansas City, Missouri, États-Unis, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, États-Unis, 63131
- Missouri Baptist Cancer Center
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Saint Louis, Missouri, États-Unis, 63141
- CCOP - St. Louis-Cape Girardeau
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Saint Louis, Missouri, États-Unis, 63141
- David C. Pratt Cancer Center at St. John's Mercy
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Saint Louis, Missouri, États-Unis, 63141
- Arch Medical Services, Incorporated at Center for Cancer Care Research
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Springfield, Missouri, États-Unis, 65802
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, États-Unis, 65804
- St. John's Regional Health Center
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Springfield, Missouri, États-Unis, 65807
- Hulston Cancer Center at Cox Medical Center South
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Montana
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Billings, Montana, États-Unis, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, États-Unis, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Billings, Montana, États-Unis, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, États-Unis, 59101
- St. Vincent Healthcare
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Billings, Montana, États-Unis, 59107-5100
- Billings Clinic Cancer Center
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Billings, Montana, États-Unis, 59107-7000
- Deaconess Billings Clinic - Downtown
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Bozeman, Montana, États-Unis, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, États-Unis, 59701
- St. James Community Hospital
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Great Falls, Montana, États-Unis, 59405
- Great Falls Clinic
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Great Falls, Montana, États-Unis, 59405
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Great Falls, Montana, États-Unis, 59405
- Big Sky Oncology
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Great Falls, Montana, États-Unis, 59405
- Sletten Regional Cancer Institute at Benefis Healthcare
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Helena, Montana, États-Unis, 59601
- St. Peter's Hospital
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Kalispell, Montana, États-Unis, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, États-Unis, 59901
- Glacier Oncology, PLLC
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Kalispell, Montana, États-Unis, 59901
- Kalispell Medical Oncology
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Missoula, Montana, États-Unis, 59801
- Community Medical Center
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Missoula, Montana, États-Unis, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, États-Unis, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, États-Unis, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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Nebraska
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Kearney, Nebraska, États-Unis, 68848-1990
- Good Samaritan Cancer Center at Good Samaritan Hospital
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Lincoln, Nebraska, États-Unis, 68510
- Cancer Resource Center - Lincoln
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Omaha, Nebraska, États-Unis, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, États-Unis, 68122
- Immanuel Medical Center
-
Omaha, Nebraska, États-Unis, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
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Omaha, Nebraska, États-Unis, 68131-2197
- Creighton University Medical Center
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Omaha, Nebraska, États-Unis, 68114
- Methodist Cancer Center at Methodist Hospital - Omaha
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Nevada
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Las Vegas, Nevada, États-Unis, 89102
- University Medical Center of Southern Nevada
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Las Vegas, Nevada, États-Unis, 89106
- CCOP - Nevada Cancer Research Foundation
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New Jersey
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Flemington, New Jersey, États-Unis, 08822
- Hunterdon Regional Cancer Center at Hunterdon Medical Center
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Morristown, New Jersey, États-Unis, 07962
- Carol G. Simon Cancer Center at Morristown Memorial Hospital
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Neptune, New Jersey, États-Unis, 07754-0397
- Jersey Shore Cancer Center at Jersey Shore University Medical Center
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Summit, New Jersey, États-Unis, 07902
- Overlook Hospital
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New York
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Bronx, New York, États-Unis, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Buffalo, New York, États-Unis, 14215
- Veterans Affairs Medical Center - Buffalo
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Clifton Springs, New York, États-Unis, 14432
- Finger Lakes Hematology and Oncology
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Glens Falls, New York, États-Unis, 12801
- Adirondack Cancer Care - Glens Falls
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Manhasset, New York, États-Unis, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, États-Unis, 11030
- Don Monti Comprehensive Cancer Center at North Shore University Hospital
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Middletown, New York, États-Unis, 10940-4199
- Tucker Center for Cancer Care at Orange Regional Medical Center
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Mineola, New York, États-Unis, 11501
- Winthrop University Hospital
-
New Hyde Park, New York, États-Unis, 11042
- Long Island Jewish Medical Center
-
Rochester, New York, États-Unis, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
-
Rochester, New York, États-Unis, 14623
- Interlakes Oncology/Hematology PC
-
Syracuse, New York, États-Unis, 13210
- SUNY Upstate Medical University Hospital
-
-
North Carolina
-
Goldsboro, North Carolina, États-Unis, 27534
- Wayne Memorial Hospital, Incorporated
-
Kinston, North Carolina, États-Unis, 28501
- Lenoir Memorial Cancer Center
-
Rutherfordton, North Carolina, États-Unis, 28139
- Rutherford Hospital
-
Wilmington, North Carolina, États-Unis, 28401
- Zimmer Cancer Center at New Hanover Regional Medical Center
-
-
North Dakota
-
Bismarck, North Dakota, États-Unis, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, États-Unis, 58501
- Medcenter One Hospital Cancer Care Center
-
Bismarck, North Dakota, États-Unis, 58501
- Mid Dakota Clinic, PC
-
Bismarck, North Dakota, États-Unis, 58502
- St. Alexius Medical Center Cancer Center
-
Fargo, North Dakota, États-Unis, 58122
- CCOP - MeritCare Hospital
-
Fargo, North Dakota, États-Unis, 58122
- MeritCare Broadway
-
Fargo, North Dakota, États-Unis, 58103
- Dakota Cancer Institute at Dakota Clinic - South University
-
-
Ohio
-
Akron, Ohio, États-Unis, 44307
- McDowell Cancer Center at Akron General Medical Center
-
Bowling Green, Ohio, États-Unis, 43402
- Wood County Oncology Center
-
Canton, Ohio, États-Unis, 44708
- Mercy Cancer Center at Mercy Medical Center
-
Chillicothe, Ohio, États-Unis, 45601
- Adena Regional Medical Center
-
Cincinnati, Ohio, États-Unis, 45267
- Charles M. Barrett Cancer Center at University Hospital
-
Cleveland, Ohio, États-Unis, 44195
- Cleveland Clinic Taussig Cancer Center
-
Cleveland, Ohio, États-Unis, 44109
- MetroHealth's Cancer Care Center at MetroHealth Medical Center
-
Columbus, Ohio, États-Unis, 43214-3998
- Riverside Methodist Hospital Cancer Care
-
Columbus, Ohio, États-Unis, 43222
- Mount Carmel Health - West Hospital
-
Columbus, Ohio, États-Unis, 43215
- CCOP - Columbus
-
Columbus, Ohio, États-Unis, 43228
- Doctors Hospital at Ohio Health
-
Columbus, Ohio, États-Unis, 43215
- Grant Riverside Cancer Services
-
Dayton, Ohio, États-Unis, 45428
- Veterans Affairs Medical Center - Dayton
-
Dayton, Ohio, États-Unis, 45405
- Grandview Hospital
-
Dayton, Ohio, États-Unis, 45406
- Good Samaritan Hospital
-
Dayton, Ohio, États-Unis, 45415
- Samaritan North Cancer Care Center
-
Dayton, Ohio, États-Unis, 45429
- CCOP - Dayton
-
Delaware, Ohio, États-Unis, 43015
- Grady Memorial Hospital
-
Findlay, Ohio, États-Unis, 45840
- Blanchard Valley Medical Associates
-
Fremont, Ohio, États-Unis, 43420
- Fremont Memorial Hospital
-
Independence, Ohio, États-Unis, 44131
- Community Oncology Group at Cleveland Clinic Cancer Center
-
Kenton, Ohio, États-Unis, 43326
- Kenton Oncology, Incorporated
-
Kettering, Ohio, États-Unis, 45429
- Charles F. Kettering Memorial Hospital
-
Lancaster, Ohio, États-Unis, 43130
- Fairfield Medical Center
-
Lima, Ohio, États-Unis, 45804
- Lima Memorial Hospital
-
Lima, Ohio, États-Unis, 45801
- St. Rita's Medical Center
-
Mansfield, Ohio, États-Unis, 44903
- MedCentral - Mansfield Hospital
-
Marietta, Ohio, États-Unis, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
-
Maumee, Ohio, États-Unis, 43537
- St. Luke's Hospital
-
Maumee, Ohio, États-Unis, 43623
- Northwest Ohio Oncology Center
-
Middletown, Ohio, États-Unis, 45044
- Middletown Regional Hospital
-
Newark, Ohio, États-Unis, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
-
Oregon, Ohio, États-Unis, 43616
- St. Charles Mercy Hospital
-
Oregon, Ohio, États-Unis, 43616
- Toledo Clinic - Oregon
-
Sandusky, Ohio, États-Unis, 44870
- Firelands Regional Medical Center
-
Sandusky, Ohio, États-Unis, 44870
- North Coast Cancer Care, Incorporated
-
Springfield, Ohio, États-Unis, 45505
- Community Hospital of Springfield and Clark County
-
Springfield, Ohio, États-Unis, 45504
- Mercy Medical Center
-
Sylvania, Ohio, États-Unis, 43560
- Flower Hospital Cancer Center
-
Toledo, Ohio, États-Unis, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, États-Unis, 43606
- Toledo Hospital
-
Toledo, Ohio, États-Unis, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, États-Unis, 43617
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, États-Unis, 43623
- Toledo Clinic, Incorporated - Main Clinic
-
Troy, Ohio, États-Unis, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Wauseon, Ohio, États-Unis, 43567
- Fulton County Health Center
-
Westerville, Ohio, États-Unis, 43081
- Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
-
Wooster, Ohio, États-Unis, 44691
- Cleveland Clinic - Wooster
-
Xenia, Ohio, États-Unis, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
-
Youngstown, Ohio, États-Unis, 44501
- Tod Children's Hospital - Forum Health
-
Zanesville, Ohio, États-Unis, 43701
- Genesis - Good Samaritan Hospital
-
-
Oregon
-
Klamath Falls, Oregon, États-Unis, 97601
- Merle West Medical Center Cancer Treatment Center
-
Portland, Oregon, États-Unis, 97207
- Veterans Affairs Medical Center - Portland
-
Portland, Oregon, États-Unis, 97239-3098
- Oregon Health & Science University Cancer Institute
-
Portland, Oregon, États-Unis, 97232
- Kaiser Permanente Health Care - Portland
-
Salem, Oregon, États-Unis, 97309-5014
- Salem Hospital Regional Cancer Care Services
-
-
Pennsylvania
-
Allentown, Pennsylvania, États-Unis, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
-
Danville, Pennsylvania, États-Unis, 17822-0001
- Geisinger Medical Center
-
DuBois, Pennsylvania, États-Unis, 15801
- Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center
-
Easton, Pennsylvania, États-Unis, 18042
- Easton Regional Cancer Center at Easton Hospital
-
Harrisburg, Pennsylvania, États-Unis, 17105
- PinnacleHealth Regional Cancer Center at Polyclinic Hospital
-
Lancaster, Pennsylvania, États-Unis, 17604
- Lancaster General Hospital
-
Langhorne, Pennsylvania, États-Unis, 19047
- St. Mary Regional Cancer Center
-
Pittsburgh, Pennsylvania, États-Unis, 15212
- Allegheny Cancer Center at Allegheny General Hospital
-
Scranton, Pennsylvania, États-Unis, 18501
- Mercy Hospital Cancer Center - Scranton
-
Scranton, Pennsylvania, États-Unis, 18510
- Hematology and Oncology Associates of Northeastern Pennsylvania
-
State College, Pennsylvania, États-Unis, 16801
- Geisinger Medical Group - Scenery Park
-
Wilkes-Barre, Pennsylvania, États-Unis, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
-
-
South Carolina
-
Anderson, South Carolina, États-Unis, 29621
- AnMed Cancer Center
-
Charleston, South Carolina, États-Unis, 29425
- Hollings Cancer Center at Medical University of South Carolina
-
Greenville, South Carolina, États-Unis, 29615
- CCOP - Greenville
-
Greenville, South Carolina, États-Unis, 29601
- Bon Secours St. Francis Health System
-
Spartanburg, South Carolina, États-Unis, 29303
- CCOP - Upstate Carolina
-
Spartanburg, South Carolina, États-Unis, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
-
-
South Dakota
-
Rapid City, South Dakota, États-Unis, 57701
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, États-Unis, 57105
- Avera Cancer Institute
-
Sioux Falls, South Dakota, États-Unis, 57117-5039
- Sioux Valley Hospital and University of South Dakota Medical Center
-
Sioux Falls, South Dakota, États-Unis, 57105
- Medical X-Ray Center, PC
-
-
Tennessee
-
Knoxville, Tennessee, États-Unis, 37916
- Thompson Cancer Survival Center
-
Knoxville, Tennessee, États-Unis, 37920-6999
- U.T. Cancer Institute at University of Tennessee Medical Center
-
Memphis, Tennessee, États-Unis, 38104
- University of Tennessee Cancer Institute - Medical Center
-
-
Texas
-
Dallas, Texas, États-Unis, 75230
- Medical City Dallas Hospital
-
Fort Sam Houston, Texas, États-Unis, 78234
- Brooke Army Medical Center
-
Houston, Texas, États-Unis, 77030
- Ben Taub General Hospital
-
Houston, Texas, États-Unis, 77030
- Methodist Hospital
-
Houston, Texas, États-Unis, 77030
- Veterans Affairs Medical Center - Houston
-
Houston, Texas, États-Unis, 77030
- Baylor University Medical Center - Houston
-
Houston, Texas, États-Unis, 77030
- St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
-
Lackland Air Force Base, Texas, États-Unis, 78236
- Wilford Hall Medical Center
-
Lubbock, Texas, États-Unis, 79415-3364
- UMC Southwest Cancer and Research Center
-
San Antonio, Texas, États-Unis, 78229
- Cancer Therapy and Research Center
-
San Antonio, Texas, États-Unis, 78209
- Veterans Affairs Medical Center - San Antonio (Murphy)
-
San Antonio, Texas, États-Unis, 78229-3900
- University of Texas Health Science Center at San Antonio
-
San Antonio, Texas, États-Unis, 78229
- University Hospital - San Antonio
-
Temple, Texas, États-Unis, 76508
- CCOP - Scott and White Hospital
-
-
Utah
-
American Fork, Utah, États-Unis, 84003
- American Fork Hospital
-
Logan, Utah, États-Unis, 84321
- Logan Regional Hospital
-
Murray, Utah, États-Unis, 84107
- Cottonwood Hospital Medical Center
-
Ogden, Utah, États-Unis, 84403
- McKay-Dee Hospital Center
-
Provo, Utah, États-Unis, 84604
- Utah Valley Regional Medical Center - Provo
-
Saint George, Utah, États-Unis, 84770
- Dixie Regional Medical Center - East Campus
-
Salt Lake City, Utah, États-Unis, 84112
- Huntsman Cancer Institute at University of Utah
-
Salt Lake City, Utah, États-Unis, 84106
- Utah Cancer Specialists at UCS Cancer Center
-
Salt Lake City, Utah, États-Unis, 84143
- Latter Day Saints Hospital
-
-
Virginia
-
Charlottesville, Virginia, États-Unis, 22901
- Martha Jefferson Hospital Cancer Care Center
-
Danville, Virginia, États-Unis, 24541
- Danville Regional Medical Center
-
Lynchburg, Virginia, États-Unis, 24501
- Lynchburg Hematology-Oncology Clinic
-
Newport News, Virginia, États-Unis, 23601
- Peninsula Cancer Institute - Newport News Office
-
Richmond, Virginia, États-Unis, 23249
- Veterans Affairs Medical Center - Richmond
-
-
Washington
-
Auburn, Washington, États-Unis, 98002
- Auburn Regional Center for Cancer Care
-
Bellingham, Washington, États-Unis, 98225
- St. Joseph Cancer Center
-
Bremerton, Washington, États-Unis, 98310
- Olympic Hematology and Oncology
-
Centralia, Washington, États-Unis, 98531-9027
- Providence Centralia Hospital Regional Cancer Center
-
Federal Way, Washington, États-Unis, 98003
- St. Francis Hospital
-
Mount Vernon, Washington, États-Unis, 98273
- Skagit Valley Hospital Cancer Care Center
-
Olympia, Washington, États-Unis, 98506-5166
- Providence St. Peter Hospital Regional Cancer Center
-
Puyallup, Washington, États-Unis, 98372
- Good Samaritan Cancer Center
-
Seattle, Washington, États-Unis, 98104
- Harborview Medical Center
-
Seattle, Washington, États-Unis, 98104
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, États-Unis, 98104
- Minor and James Medical, PLLC
-
Seattle, Washington, États-Unis, 98112
- Group Health Central Hospital
-
Seattle, Washington, États-Unis, 98122-4307
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
-
Seattle, Washington, États-Unis, 98122
- Polyclinic First Hill
-
Seattle, Washington, États-Unis, 98195-6043
- University Cancer Center at University of Washington Medical Center
-
Spokane, Washington, États-Unis, 99202
- Cancer Care Northwest - Spokane South
-
Spokane, Washington, États-Unis, 99204-2967
- Rockwood Clinic Cancer Treatment Center
-
Spokane, Washington, États-Unis, 99204
- Providence Cancer Center at Sacred Heart Medical Center
-
Spokane, Washington, États-Unis, 99207
- Providence Cancer Center at Holy Family Hospital
-
Tacoma, Washington, États-Unis, 98405
- Allenmore Hospital
-
Tacoma, Washington, États-Unis, 98405
- CCOP - Northwest
-
Tacoma, Washington, États-Unis, 98405
- MultiCare Regional Cancer Center at Tacoma General Hospital
-
Tacoma, Washington, États-Unis, 98499
- St. Clare Hospital
-
Tacoma, Washington, États-Unis, 98405-3004
- St. Joseph Medical Center at Franciscan Health System
-
Wenatchee, Washington, États-Unis, 98801-2028
- Wenatchee Valley Medical Center
-
-
Wisconsin
-
Appleton, Wisconsin, États-Unis, 54911-3496
- Fox Valley Hematology and Oncology - East Grant Street
-
Green Bay, Wisconsin, États-Unis, 54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, États-Unis, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay, Wisconsin, États-Unis, 54303
- St. Mary's Hospital Medical Center - Green Bay
-
Green Bay, Wisconsin, États-Unis, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital
-
Janesville, Wisconsin, États-Unis, 53547
- Mercy Regional Cancer Center
-
La Crosse, Wisconsin, États-Unis, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
-
Manitowoc, Wisconsin, États-Unis, 54221-1450
- Holy Family Memorial Medical Center Cancer Care Center
-
Marinette, Wisconsin, États-Unis, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
-
Marshfield, Wisconsin, États-Unis, 54449
- Marshfield Clinic - Marshfield Center
-
Oconto Falls, Wisconsin, États-Unis, 54154
- Green Bay Oncology, Limited - Oconto Falls
-
Racine, Wisconsin, États-Unis, 53405
- All Saints Cancer Center at Wheaton Franciscan Healthcare
-
Rice Lake, Wisconsin, États-Unis, 54868
- Marshfield Clinic - Indianhead Center
-
Sturgeon Bay, Wisconsin, États-Unis, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
-
Wausau, Wisconsin, États-Unis, 54401
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
-
-
Wyoming
-
Sheridan, Wyoming, États-Unis, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 120 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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
|
|
Comparateur actif: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall Survival
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Progression-free Survival
Délai: 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.
Délai: 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.
Délai: 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.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Primo N. Lara, MD, University of California, Davis
- Chercheur principal: Ronald B. Natale, MD, Cedars-Sinai Medical Center
- Chercheur principal: David R. Gandara, MD, University of California, Davis
- Chercheur principal: James R. Jett, MD, Mayo Clinic
- Chercheur principal: Jane Carleton, MD, Don Monti Comprehensive Cancer Center at North Shore University Hospital
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 novembre 2002
Achèvement primaire (Réel)
1 mars 2008
Achèvement de l'étude (Réel)
1 décembre 2009
Dates d'inscription aux études
Première soumission
6 septembre 2002
Première soumission répondant aux critères de contrôle qualité
26 janvier 2003
Première publication (Estimation)
27 janvier 2003
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
31 juillet 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 juillet 2018
Dernière vérification
1 juillet 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies des voies respiratoires
- Tumeurs
- Maladies pulmonaires
- Tumeurs par site
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Carcinome bronchique
- Tumeurs bronchiques
- Tumeurs pulmonaires
- Carcinome pulmonaire à petites cellules
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents antinéoplasiques
- Agents antinéoplasiques phytogéniques
- Inhibiteurs de la topoisomérase II
- Inhibiteurs de la topoisomérase
- Inhibiteurs de la topoisomérase I
- Étoposide
- Irinotécan
Autres numéros d'identification d'étude
- CDR0000256908
- U10CA032102 (Subvention/contrat des NIH des États-Unis)
- S0124 (Autre identifiant: CALGB)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .