- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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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, Stati Uniti, 36202
- Northeast Alabama Regional Medical Center
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Huntsville, Alabama, Stati Uniti, 35801
- Huntsville Hospital
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Mobile, Alabama, Stati Uniti, 36652-2144
- Mobile Infirmary Medical Center
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Opelika, Alabama, Stati Uniti, 36801-5452
- East Alabama Medical Center
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Alaska
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Anchorage, Alaska, Stati Uniti, 99508
- Alaska Regional Hospital Cancer Center
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Arizona
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Scottsdale, Arizona, Stati Uniti, 85259-5499
- Mayo Clinic Scottsdale
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Tucson, Arizona, Stati Uniti, 85724-5024
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Fort Smith, Arkansas, Stati Uniti, 72903
- Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
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Little Rock, Arkansas, Stati Uniti, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Burbank, California, Stati Uniti, 91505
- Providence Saint Joseph Medical Center - Burbank
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Concord, California, Stati Uniti, 94524-4110
- Cancer Care Center at John Muir Health - Concord Campus
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Fremont, California, Stati Uniti, 94538
- Washington Township Hospital
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Fresno, California, Stati Uniti, 93720
- California Cancer Center - Woodward Park Office
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Los Angeles, California, Stati Uniti, 90089-9181
- USC/Norris Comprehensive Cancer Center and Hospital
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Palm Springs, California, Stati Uniti, 92262
- Desert Regional Medical Center Comprehensive Cancer Center
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Redding, California, Stati Uniti, 96001
- Shasta Regional Medical Center
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Roseville, California, Stati Uniti, 95661
- Sutter Cancer Center at Roseville Medical Center
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Sacramento, California, Stati Uniti, 95816
- Sutter Cancer center
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Sacramento, California, Stati Uniti, 95817
- University of California Davis Cancer Center
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Santa Rosa, California, Stati Uniti, 95405
- CCOP - Santa Rosa Memorial Hospital
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Walnut Creek, California, Stati Uniti, 94598
- John Muir/Mt. Diablo Comprehensive Cancer Center
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Colorado
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Colorado Springs, Colorado, Stati Uniti, 80909
- Memorial Hospital
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Connecticut
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Norwich, Connecticut, Stati Uniti, 06360
- Eastern Connecticut Hematology and Oncology Associates
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Florida
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Daytona Beach, Florida, Stati Uniti, 32115
- Halifax Medical Center - Daytona Beach
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Fort Lauderdale, Florida, Stati Uniti, 33316
- Broward General Medical Center Cancer Center
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Pensacola, Florida, Stati Uniti, 32514
- West Florida Cancer Institute at West Florida Hospital - Pensacola
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Georgia
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Atlanta, Georgia, Stati Uniti, 30309
- Piedmont Hospital
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Atlanta, Georgia, Stati Uniti, 30342-1611
- Northside Hospital Cancer Center
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Atlanta, Georgia, Stati Uniti, 30342-1701
- Saint Joseph's Hospital of Atlanta
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Atlanta, Georgia, Stati Uniti, 30342
- CCOP - Atlanta Regional
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Augusta, Georgia, Stati Uniti, 30901
- Augusta Oncology Associates - Walton Way
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Austell, Georgia, Stati Uniti, 30106
- WellStar Cobb Hospital
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Decatur, Georgia, Stati Uniti, 30033
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
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Lawrenceville, Georgia, Stati Uniti, 30045
- Gwinnett Medical Center
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Marietta, Georgia, Stati Uniti, 30060
- Kennestone Cancer Center at Wellstar Kennestone Hospital
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Riverdale, Georgia, Stati Uniti, 30274-2600
- Southern Regional Medical Center
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Savannah, Georgia, Stati Uniti, 31403-3089
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Valdosta, Georgia, Stati Uniti, 31603
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
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Hawaii
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Honolulu, Hawaii, Stati Uniti, 96859
- Tripler Army Medical Center
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Idaho
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Idaho Falls, Idaho, Stati Uniti, 83404
- Hematology Oncology Associates of Eastern Idaho
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Illinois
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Alton, Illinois, Stati Uniti, 62002
- Saint Anthony's Hospital at Saint Anthony's Health Center
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Aurora, Illinois, Stati Uniti, 60507
- Rush-Copley Cancer Care Center
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Decatur, Illinois, Stati Uniti, 62526
- Decatur Memorial Hospital Cancer Care Institute
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Elmhurst, Illinois, Stati Uniti, 60126
- Elmhurst Memorial Hospital
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Hines, Illinois, Stati Uniti, 60141
- Veterans Affairs Medical Center - Hines
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Joliet, Illinois, Stati Uniti, 60435
- Joliet Oncology-Hematology Associates, Limited - West
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La Grange, Illinois, Stati Uniti, 60525
- La Grange Memorial Hospital
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Maywood, Illinois, Stati Uniti, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Moline, Illinois, Stati Uniti, 61265
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Moline, Illinois, Stati Uniti, 61265
- Trinity Medical Center - East
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Mount Vernon, Illinois, Stati Uniti, 62864
- Good Samaritan Regional Health Center
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River Forest, Illinois, Stati Uniti, 60305
- West Suburban Center for Cancer Care
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Rockford, Illinois, Stati Uniti, 61104-2315
- Swedish-American Regional Cancer Center
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Springfield, Illinois, Stati Uniti, 62781-0001
- Regional Cancer Center at Memorial Medical Center
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Urbana, Illinois, Stati Uniti, 61801
- Carle Cancer Center at Carle Foundation Hospital
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Urbana, Illinois, Stati Uniti, 61801
- CCOP - Carle Cancer Center
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Indiana
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Beech Grove, Indiana, Stati Uniti, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Elkhart, Indiana, Stati Uniti, 46515
- Elkhart General Hospital
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Kokomo, Indiana, Stati Uniti, 46904
- Howard Community Hospital at Howard Regional Health System
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La Porte, Indiana, Stati Uniti, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Michigan City, Indiana, Stati Uniti, 46360
- Saint Anthony Memorial Health Centers
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Richmond, Indiana, Stati Uniti, 47374
- Reid Hospital & Health Care Services, Incorporated
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South Bend, Indiana, Stati Uniti, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Stati Uniti, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, Stati Uniti, 46617
- Saint Joseph Regional Medical Center
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Iowa
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Bettendorf, Iowa, Stati Uniti, 52722
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Bettendorf, Iowa, Stati Uniti, 52722
- Hematology Oncology Associates of the Quad Cities
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Cedar Rapids, Iowa, Stati Uniti, 52402
- St. Luke's Hospital
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Cedar Rapids, Iowa, Stati Uniti, 52403
- Cedar Rapids Oncology Associates
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Cedar Rapids, Iowa, Stati Uniti, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Council Bluffs, Iowa, Stati Uniti, 51503
- Heartland Oncology & Hematology
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Davenport, Iowa, Stati Uniti, 52804
- Genesis Medical Center - West Campus
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Davenport, Iowa, Stati Uniti, 52803
- Genesis Regional Cancer Center at Genesis Medical Center
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Des Moines, Iowa, Stati Uniti, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Stati Uniti, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Stati Uniti, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Stati Uniti, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Stati Uniti, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Stati Uniti, 50307
- Mercy Capitol Hospital
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Des Moines, Iowa, Stati Uniti, 50316-2301
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Mason City, Iowa, Stati Uniti, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
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Ottumwa, Iowa, Stati Uniti, 52501
- McCreery Cancer Center at Ottumwa Regional
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Sioux City, Iowa, Stati Uniti, 51101
- Siouxland Regional Cancer Center
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Sioux City, Iowa, Stati Uniti, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Stati Uniti, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, Stati Uniti, 51104
- Mercy Medical Center - Sioux City
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Waterloo, Iowa, Stati Uniti, 50702
- Covenant Cancer Treatment Center
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Waterloo, Iowa, Stati Uniti, 50702
- Cedar Valley Medical Specialists, PC - West Ridgeway Avenue
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Kansas
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Chanute, Kansas, Stati Uniti, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Stati Uniti, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Stati Uniti, 67042
- Cancer Center of Kansas, PA - El Dorado
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Kansas City, Kansas, Stati Uniti, 64128
- Veterans Affairs Medical Center - Kansas City
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Kingman, Kansas, Stati Uniti, 67068
- Cancer Center of Kansas, PA - Kingman
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Liberal, Kansas, Stati Uniti, 67901
- Southwest Medical Center
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Newton, Kansas, Stati Uniti, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Stati Uniti, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Stati Uniti, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Stati Uniti, 67042
- Cancer Center of Kansas, PA - Salina
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Salina, Kansas, Stati Uniti, 67401
- Tammy Walker Cancer Center at Salina Regional Health Center
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Topeka, Kansas, Stati Uniti, 66604
- Stormont-Vail Cancer Center
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Wellington, Kansas, Stati Uniti, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Stati Uniti, 67203
- Associates in Womens Health, PA - North Review
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Wichita, Kansas, Stati Uniti, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Stati Uniti, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Stati Uniti, 67214
- CCOP - Wichita
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Wichita, Kansas, Stati Uniti, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Winfield, Kansas, Stati Uniti, 67156
- Cancer Center of Kansas, PA - Winfield
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Kentucky
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Madisonville, Kentucky, Stati Uniti, 42431
- Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
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Louisiana
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Alexandria, Louisiana, Stati Uniti, 71315-3198
- Tulane Cancer Center
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Monroe, Louisiana, Stati Uniti, 71210
- Louisiana State University Health Sciences Center - Monroe
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Shreveport, Louisiana, Stati Uniti, 71130-3932
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
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Shreveport, Louisiana, Stati Uniti, 71101
- Veterans Affairs Medical Center - Shreveport
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Shreveport, Louisiana, Stati Uniti, 71101
- Christus Schumpert Cancer Treatment Center
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Maine
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Bangor, Maine, Stati Uniti, 04401
- CancerCare of Maine at Eastern Maine Medial Center
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Waterville, Maine, Stati Uniti, 04901
- MaineGeneral Medical Center - Waterville Campus
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Massachusetts
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Attleboro, Massachusetts, Stati Uniti, 02703
- Sturdy Memorial Hospital
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Boston, Massachusetts, Stati Uniti, 02118
- Cancer Research Center at Boston Medical Center
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Gloucester, Massachusetts, Stati Uniti, 01930
- Addison Gilbert Hospital
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Worcester, Massachusetts, Stati Uniti, 01655
- UMASS Memorial Cancer Center - University Campus
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Michigan
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Adrian, Michigan, Stati Uniti, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, Stati Uniti, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, Stati Uniti, 48106
- CCOP - Michigan Cancer Research Consortium
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Battle Creek, Michigan, Stati Uniti, 49017
- Battle Creek Health System Cancer Care Center
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Big Rapids, Michigan, Stati Uniti, 49307
- Mecosta County Medical Center
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Detroit, Michigan, Stati Uniti, 48202
- Josephine Ford Cancer Center at Henry Ford Hospital
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Escanaba, Michigan, Stati Uniti, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, Stati Uniti, 48503
- Hurley Medical Center
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Flint, Michigan, Stati Uniti, 48503
- Genesys Hurley Cancer Institute
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Grand Rapids, Michigan, Stati Uniti, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, Stati Uniti, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Grand Rapids, Michigan, Stati Uniti, 49506
- Metro Health Hospital
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Grand Rapids, Michigan, Stati Uniti, 49503
- Spectrum Health Hospital - Butterworth Campus
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Grosse Pointe Woods, Michigan, Stati Uniti, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Holland, Michigan, Stati Uniti, 49423
- Holland Community Hospital
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Iron Mountain, Michigan, Stati Uniti, 49801
- Green Bay Oncology, Limited - Iron Mountain
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Jackson, Michigan, Stati Uniti, 49201
- Foote Hospital
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Kalamazoo, Michigan, Stati Uniti, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Stati Uniti, 49001
- Borgess Medical Center
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Kalamazoo, Michigan, Stati Uniti, 49007-3731
- West Michigan Cancer Center
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Lansing, Michigan, Stati Uniti, 48909
- Sparrow Regional Cancer Center
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Marquette, Michigan, Stati Uniti, 49855
- Upper Michigan Cancer Center at Marquette General Hospital
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Midland, Michigan, Stati Uniti, 48670
- MidMichigan Medical Center - Midland
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Monroe, Michigan, Stati Uniti, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, Stati Uniti, 48162
- Mercy Memorial Hospital System
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Mount Clemens, Michigan, Stati Uniti, 48043
- Ted B. Wahby Cancer Center at Mount Clemens General Hospital
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Muskegon, Michigan, Stati Uniti, 49442
- Hackley Hospital
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Petoskey, Michigan, Stati Uniti, 49770
- Northern Michigan Hospital
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Port Huron, Michigan, Stati Uniti, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Saginaw, Michigan, Stati Uniti, 48601
- Seton Cancer Institute - Saginaw
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Saint Joseph, Michigan, Stati Uniti, 49085
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
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Traverse City, Michigan, Stati Uniti, 49684
- Munson Medical Center
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Warren, Michigan, Stati Uniti, 48093
- St. John Macomb Hospital
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Minnesota
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Alexandria, Minnesota, Stati Uniti, 56308
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Bemidji, Minnesota, Stati Uniti, 56601
- MeritCare Clinic - Bemidji
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Burnsville, Minnesota, Stati Uniti, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Stati Uniti, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Stati Uniti, 55805
- CCOP - Duluth
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Duluth, Minnesota, Stati Uniti, 55805
- St. Mary's - Duluth Clinic Cancer Center
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Duluth, Minnesota, Stati Uniti, 55805
- Miller-Dwan Medical Center
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Duluth, Minnesota, Stati Uniti, 55805
- Cancer Care Center at St. Luke's Hospital
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Edina, Minnesota, Stati Uniti, 55435
- Fairview Southdale Hospital
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Fergus Falls, Minnesota, Stati Uniti, 56537
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Fridley, Minnesota, Stati Uniti, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Stati Uniti, 55350
- Hutchinson Area Health Care
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Litchfield, Minnesota, Stati Uniti, 55355
- Meeker County Memorial Hospital
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Mankato, Minnesota, Stati Uniti, 56002
- Immanuel St. Joseph's Clinic
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Maplewood, Minnesota, Stati Uniti, 55109
- HealthEast Cancer Care at St. John's Hospital
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Maplewood, Minnesota, Stati Uniti, 55109
- Minnesota Oncology Hematology, PA at Maplewood Cancer Center
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Minneapolis, Minnesota, Stati Uniti, 55415
- Hennepin County Medical Center - Minneapolis
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Minneapolis, Minnesota, Stati Uniti, 55407
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
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Montevideo, Minnesota, Stati Uniti, 56265
- Chippewa County - Montevideo Hospital
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Robbinsdale, Minnesota, Stati Uniti, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
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Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Stati Uniti, 56303
- CentraCare Clinic - River Campus
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Saint Cloud, Minnesota, Stati Uniti, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, Stati Uniti, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, Stati Uniti, 55416
- Park Nicollet Health Services
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Saint Paul, Minnesota, Stati Uniti, 55102
- St. Joseph's Hospital
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Saint Paul, Minnesota, Stati Uniti, 55102
- United Hospital
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Saint Paul, Minnesota, Stati Uniti, 55101
- Regions Hospital Cancer Care Center
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Shakopee, Minnesota, Stati Uniti, 55379
- Saint Francis Cancer Center
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Waconia, Minnesota, Stati Uniti, 55387
- Ridgeview Medical Center
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Willmar, Minnesota, Stati Uniti, 56201
- Willmar Cancer Center at Rice Memorial Hospital
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Woodbury, Minnesota, Stati Uniti, 55125
- Woodwinds Health Campus
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Woodbury, Minnesota, Stati Uniti, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Mississippi
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Jackson, Mississippi, Stati Uniti, 39216
- University of Mississippi Medical Center
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Missouri
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Cape Girardeau, Missouri, Stati Uniti, 63701
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
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Cape Girardeau, Missouri, Stati Uniti, 63701
- Saint Francis Medical Center
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Columbia, Missouri, Stati Uniti, 65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
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Columbia, Missouri, Stati Uniti, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Jefferson City, Missouri, Stati Uniti, 65101
- Capital Region Cancer Center
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Joplin, Missouri, Stati Uniti, 64804
- Freeman Cancer Institute at Freeman Health System
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Kansas City, Missouri, Stati Uniti, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Stati Uniti, 63131
- Missouri Baptist Cancer Center
-
Saint Louis, Missouri, Stati Uniti, 63141
- CCOP - St. Louis-Cape Girardeau
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Saint Louis, Missouri, Stati Uniti, 63141
- David C. Pratt Cancer Center at St. John's Mercy
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Saint Louis, Missouri, Stati Uniti, 63141
- Arch Medical Services, Incorporated at Center for Cancer Care Research
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Springfield, Missouri, Stati Uniti, 65802
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, Stati Uniti, 65804
- St. John's Regional Health Center
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Springfield, Missouri, Stati Uniti, 65807
- Hulston Cancer Center at Cox Medical Center South
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Montana
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Billings, Montana, Stati Uniti, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, Stati Uniti, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Billings, Montana, Stati Uniti, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, Stati Uniti, 59101
- St. Vincent Healthcare
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Billings, Montana, Stati Uniti, 59107-5100
- Billings Clinic Cancer Center
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Billings, Montana, Stati Uniti, 59107-7000
- Deaconess Billings Clinic - Downtown
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Bozeman, Montana, Stati Uniti, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, Stati Uniti, 59701
- St. James Community Hospital
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Great Falls, Montana, Stati Uniti, 59405
- Great Falls Clinic
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Great Falls, Montana, Stati Uniti, 59405
-
Great Falls, Montana, Stati Uniti, 59405
- Big Sky Oncology
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Great Falls, Montana, Stati Uniti, 59405
- Sletten Regional Cancer Institute at Benefis Healthcare
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Helena, Montana, Stati Uniti, 59601
- St. Peter's Hospital
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Kalispell, Montana, Stati Uniti, 59901
- Kalispell Regional Medical Center
-
Kalispell, Montana, Stati Uniti, 59901
- Glacier Oncology, PLLC
-
Kalispell, Montana, Stati Uniti, 59901
- Kalispell Medical Oncology
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Missoula, Montana, Stati Uniti, 59801
- Community Medical Center
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Missoula, Montana, Stati Uniti, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, Stati Uniti, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
-
Missoula, Montana, Stati Uniti, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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Nebraska
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Kearney, Nebraska, Stati Uniti, 68848-1990
- Good Samaritan Cancer Center at Good Samaritan Hospital
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Lincoln, Nebraska, Stati Uniti, 68510
- Cancer Resource Center - Lincoln
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Omaha, Nebraska, Stati Uniti, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Stati Uniti, 68122
- Immanuel Medical Center
-
Omaha, Nebraska, Stati Uniti, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
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Omaha, Nebraska, Stati Uniti, 68131-2197
- Creighton University Medical Center
-
Omaha, Nebraska, Stati Uniti, 68114
- Methodist Cancer Center at Methodist Hospital - Omaha
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89102
- University Medical Center of Southern Nevada
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Las Vegas, Nevada, Stati Uniti, 89106
- CCOP - Nevada Cancer Research Foundation
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New Jersey
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Flemington, New Jersey, Stati Uniti, 08822
- Hunterdon Regional Cancer Center at Hunterdon Medical Center
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Morristown, New Jersey, Stati Uniti, 07962
- Carol G. Simon Cancer Center at Morristown Memorial Hospital
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Neptune, New Jersey, Stati Uniti, 07754-0397
- Jersey Shore Cancer Center at Jersey Shore University Medical Center
-
Summit, New Jersey, Stati Uniti, 07902
- Overlook Hospital
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New York
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Bronx, New York, Stati Uniti, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Buffalo, New York, Stati Uniti, 14215
- Veterans Affairs Medical Center - Buffalo
-
Clifton Springs, New York, Stati Uniti, 14432
- Finger Lakes Hematology and Oncology
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Glens Falls, New York, Stati Uniti, 12801
- Adirondack Cancer Care - Glens Falls
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Manhasset, New York, Stati Uniti, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, Stati Uniti, 11030
- Don Monti Comprehensive Cancer Center at North Shore University Hospital
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Middletown, New York, Stati Uniti, 10940-4199
- Tucker Center for Cancer Care at Orange Regional Medical Center
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Mineola, New York, Stati Uniti, 11501
- Winthrop University Hospital
-
New Hyde Park, New York, Stati Uniti, 11042
- Long Island Jewish Medical Center
-
Rochester, New York, Stati Uniti, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Rochester, New York, Stati Uniti, 14623
- Interlakes Oncology/Hematology PC
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Syracuse, New York, Stati Uniti, 13210
- SUNY Upstate Medical University Hospital
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North Carolina
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Goldsboro, North Carolina, Stati Uniti, 27534
- Wayne Memorial Hospital, Incorporated
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Kinston, North Carolina, Stati Uniti, 28501
- Lenoir Memorial Cancer Center
-
Rutherfordton, North Carolina, Stati Uniti, 28139
- Rutherford Hospital
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Wilmington, North Carolina, Stati Uniti, 28401
- Zimmer Cancer Center at New Hanover Regional Medical Center
-
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North Dakota
-
Bismarck, North Dakota, Stati Uniti, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, Stati Uniti, 58501
- Medcenter One Hospital Cancer Care Center
-
Bismarck, North Dakota, Stati Uniti, 58501
- Mid Dakota Clinic, PC
-
Bismarck, North Dakota, Stati Uniti, 58502
- St. Alexius Medical Center Cancer Center
-
Fargo, North Dakota, Stati Uniti, 58122
- CCOP - MeritCare Hospital
-
Fargo, North Dakota, Stati Uniti, 58122
- MeritCare Broadway
-
Fargo, North Dakota, Stati Uniti, 58103
- Dakota Cancer Institute at Dakota Clinic - South University
-
-
Ohio
-
Akron, Ohio, Stati Uniti, 44307
- McDowell Cancer Center at Akron General Medical Center
-
Bowling Green, Ohio, Stati Uniti, 43402
- Wood County Oncology Center
-
Canton, Ohio, Stati Uniti, 44708
- Mercy Cancer Center at Mercy Medical Center
-
Chillicothe, Ohio, Stati Uniti, 45601
- Adena Regional Medical Center
-
Cincinnati, Ohio, Stati Uniti, 45267
- Charles M. Barrett Cancer Center at University Hospital
-
Cleveland, Ohio, Stati Uniti, 44195
- Cleveland Clinic Taussig Cancer Center
-
Cleveland, Ohio, Stati Uniti, 44109
- MetroHealth's Cancer Care Center at MetroHealth Medical Center
-
Columbus, Ohio, Stati Uniti, 43214-3998
- Riverside Methodist Hospital Cancer Care
-
Columbus, Ohio, Stati Uniti, 43222
- Mount Carmel Health - West Hospital
-
Columbus, Ohio, Stati Uniti, 43215
- CCOP - Columbus
-
Columbus, Ohio, Stati Uniti, 43228
- Doctors Hospital at Ohio Health
-
Columbus, Ohio, Stati Uniti, 43215
- Grant Riverside Cancer Services
-
Dayton, Ohio, Stati Uniti, 45428
- Veterans Affairs Medical Center - Dayton
-
Dayton, Ohio, Stati Uniti, 45405
- Grandview Hospital
-
Dayton, Ohio, Stati Uniti, 45406
- Good Samaritan Hospital
-
Dayton, Ohio, Stati Uniti, 45415
- Samaritan North Cancer Care Center
-
Dayton, Ohio, Stati Uniti, 45429
- CCOP - Dayton
-
Delaware, Ohio, Stati Uniti, 43015
- Grady Memorial Hospital
-
Findlay, Ohio, Stati Uniti, 45840
- Blanchard Valley Medical Associates
-
Fremont, Ohio, Stati Uniti, 43420
- Fremont Memorial Hospital
-
Independence, Ohio, Stati Uniti, 44131
- Community Oncology Group at Cleveland Clinic Cancer Center
-
Kenton, Ohio, Stati Uniti, 43326
- Kenton Oncology, Incorporated
-
Kettering, Ohio, Stati Uniti, 45429
- Charles F. Kettering Memorial Hospital
-
Lancaster, Ohio, Stati Uniti, 43130
- Fairfield Medical Center
-
Lima, Ohio, Stati Uniti, 45804
- Lima Memorial Hospital
-
Lima, Ohio, Stati Uniti, 45801
- St. Rita's Medical Center
-
Mansfield, Ohio, Stati Uniti, 44903
- MedCentral - Mansfield Hospital
-
Marietta, Ohio, Stati Uniti, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
-
Maumee, Ohio, Stati Uniti, 43537
- St. Luke's Hospital
-
Maumee, Ohio, Stati Uniti, 43623
- Northwest Ohio Oncology Center
-
Middletown, Ohio, Stati Uniti, 45044
- Middletown Regional Hospital
-
Newark, Ohio, Stati Uniti, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
-
Oregon, Ohio, Stati Uniti, 43616
- St. Charles Mercy Hospital
-
Oregon, Ohio, Stati Uniti, 43616
- Toledo Clinic - Oregon
-
Sandusky, Ohio, Stati Uniti, 44870
- Firelands Regional Medical Center
-
Sandusky, Ohio, Stati Uniti, 44870
- North Coast Cancer Care, Incorporated
-
Springfield, Ohio, Stati Uniti, 45505
- Community Hospital of Springfield and Clark County
-
Springfield, Ohio, Stati Uniti, 45504
- Mercy Medical Center
-
Sylvania, Ohio, Stati Uniti, 43560
- Flower Hospital Cancer Center
-
Toledo, Ohio, Stati Uniti, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, Stati Uniti, 43606
- Toledo Hospital
-
Toledo, Ohio, Stati Uniti, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, Stati Uniti, 43617
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, Stati Uniti, 43623
- Toledo Clinic, Incorporated - Main Clinic
-
Troy, Ohio, Stati Uniti, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Wauseon, Ohio, Stati Uniti, 43567
- Fulton County Health Center
-
Westerville, Ohio, Stati Uniti, 43081
- Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
-
Wooster, Ohio, Stati Uniti, 44691
- Cleveland Clinic - Wooster
-
Xenia, Ohio, Stati Uniti, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
-
Youngstown, Ohio, Stati Uniti, 44501
- Tod Children's Hospital - Forum Health
-
Zanesville, Ohio, Stati Uniti, 43701
- Genesis - Good Samaritan Hospital
-
-
Oregon
-
Klamath Falls, Oregon, Stati Uniti, 97601
- Merle West Medical Center Cancer Treatment Center
-
Portland, Oregon, Stati Uniti, 97207
- Veterans Affairs Medical Center - Portland
-
Portland, Oregon, Stati Uniti, 97239-3098
- Oregon Health & Science University Cancer Institute
-
Portland, Oregon, Stati Uniti, 97232
- Kaiser Permanente Health Care - Portland
-
Salem, Oregon, Stati Uniti, 97309-5014
- Salem Hospital Regional Cancer Care Services
-
-
Pennsylvania
-
Allentown, Pennsylvania, Stati Uniti, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
-
Danville, Pennsylvania, Stati Uniti, 17822-0001
- Geisinger Medical Center
-
DuBois, Pennsylvania, Stati Uniti, 15801
- Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center
-
Easton, Pennsylvania, Stati Uniti, 18042
- Easton Regional Cancer Center at Easton Hospital
-
Harrisburg, Pennsylvania, Stati Uniti, 17105
- PinnacleHealth Regional Cancer Center at Polyclinic Hospital
-
Lancaster, Pennsylvania, Stati Uniti, 17604
- Lancaster General Hospital
-
Langhorne, Pennsylvania, Stati Uniti, 19047
- St. Mary Regional Cancer Center
-
Pittsburgh, Pennsylvania, Stati Uniti, 15212
- Allegheny Cancer Center at Allegheny General Hospital
-
Scranton, Pennsylvania, Stati Uniti, 18501
- Mercy Hospital Cancer Center - Scranton
-
Scranton, Pennsylvania, Stati Uniti, 18510
- Hematology and Oncology Associates of Northeastern Pennsylvania
-
State College, Pennsylvania, Stati Uniti, 16801
- Geisinger Medical Group - Scenery Park
-
Wilkes-Barre, Pennsylvania, Stati Uniti, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
-
-
South Carolina
-
Anderson, South Carolina, Stati Uniti, 29621
- AnMed Cancer Center
-
Charleston, South Carolina, Stati Uniti, 29425
- Hollings Cancer Center at Medical University of South Carolina
-
Greenville, South Carolina, Stati Uniti, 29615
- CCOP - Greenville
-
Greenville, South Carolina, Stati Uniti, 29601
- Bon Secours St. Francis Health System
-
Spartanburg, South Carolina, Stati Uniti, 29303
- CCOP - Upstate Carolina
-
Spartanburg, South Carolina, Stati Uniti, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
-
-
South Dakota
-
Rapid City, South Dakota, Stati Uniti, 57701
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, Stati Uniti, 57105
- Avera Cancer Institute
-
Sioux Falls, South Dakota, Stati Uniti, 57117-5039
- Sioux Valley Hospital and University of South Dakota Medical Center
-
Sioux Falls, South Dakota, Stati Uniti, 57105
- Medical X-Ray Center, PC
-
-
Tennessee
-
Knoxville, Tennessee, Stati Uniti, 37916
- Thompson Cancer Survival Center
-
Knoxville, Tennessee, Stati Uniti, 37920-6999
- U.T. Cancer Institute at University of Tennessee Medical Center
-
Memphis, Tennessee, Stati Uniti, 38104
- University of Tennessee Cancer Institute - Medical Center
-
-
Texas
-
Dallas, Texas, Stati Uniti, 75230
- Medical City Dallas Hospital
-
Fort Sam Houston, Texas, Stati Uniti, 78234
- Brooke Army Medical Center
-
Houston, Texas, Stati Uniti, 77030
- Ben Taub General Hospital
-
Houston, Texas, Stati Uniti, 77030
- Methodist Hospital
-
Houston, Texas, Stati Uniti, 77030
- Veterans Affairs Medical Center - Houston
-
Houston, Texas, Stati Uniti, 77030
- Baylor University Medical Center - Houston
-
Houston, Texas, Stati Uniti, 77030
- St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
-
Lackland Air Force Base, Texas, Stati Uniti, 78236
- Wilford Hall Medical Center
-
Lubbock, Texas, Stati Uniti, 79415-3364
- UMC Southwest Cancer and Research Center
-
San Antonio, Texas, Stati Uniti, 78229
- Cancer Therapy and Research Center
-
San Antonio, Texas, Stati Uniti, 78209
- Veterans Affairs Medical Center - San Antonio (Murphy)
-
San Antonio, Texas, Stati Uniti, 78229-3900
- University of Texas Health Science Center at San Antonio
-
San Antonio, Texas, Stati Uniti, 78229
- University Hospital - San Antonio
-
Temple, Texas, Stati Uniti, 76508
- CCOP - Scott and White Hospital
-
-
Utah
-
American Fork, Utah, Stati Uniti, 84003
- American Fork Hospital
-
Logan, Utah, Stati Uniti, 84321
- Logan Regional Hospital
-
Murray, Utah, Stati Uniti, 84107
- Cottonwood Hospital Medical Center
-
Ogden, Utah, Stati Uniti, 84403
- McKay-Dee Hospital Center
-
Provo, Utah, Stati Uniti, 84604
- Utah Valley Regional Medical Center - Provo
-
Saint George, Utah, Stati Uniti, 84770
- Dixie Regional Medical Center - East Campus
-
Salt Lake City, Utah, Stati Uniti, 84112
- Huntsman Cancer Institute at University of Utah
-
Salt Lake City, Utah, Stati Uniti, 84106
- Utah Cancer Specialists at UCS Cancer Center
-
Salt Lake City, Utah, Stati Uniti, 84143
- Latter Day Saints Hospital
-
-
Virginia
-
Charlottesville, Virginia, Stati Uniti, 22901
- Martha Jefferson Hospital Cancer Care Center
-
Danville, Virginia, Stati Uniti, 24541
- Danville Regional Medical Center
-
Lynchburg, Virginia, Stati Uniti, 24501
- Lynchburg Hematology-Oncology Clinic
-
Newport News, Virginia, Stati Uniti, 23601
- Peninsula Cancer Institute - Newport News Office
-
Richmond, Virginia, Stati Uniti, 23249
- Veterans Affairs Medical Center - Richmond
-
-
Washington
-
Auburn, Washington, Stati Uniti, 98002
- Auburn Regional Center for Cancer Care
-
Bellingham, Washington, Stati Uniti, 98225
- St. Joseph Cancer Center
-
Bremerton, Washington, Stati Uniti, 98310
- Olympic Hematology and Oncology
-
Centralia, Washington, Stati Uniti, 98531-9027
- Providence Centralia Hospital Regional Cancer Center
-
Federal Way, Washington, Stati Uniti, 98003
- St. Francis Hospital
-
Mount Vernon, Washington, Stati Uniti, 98273
- Skagit Valley Hospital Cancer Care Center
-
Olympia, Washington, Stati Uniti, 98506-5166
- Providence St. Peter Hospital Regional Cancer Center
-
Puyallup, Washington, Stati Uniti, 98372
- Good Samaritan Cancer Center
-
Seattle, Washington, Stati Uniti, 98104
- Harborview Medical Center
-
Seattle, Washington, Stati Uniti, 98104
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, Stati Uniti, 98104
- Minor and James Medical, PLLC
-
Seattle, Washington, Stati Uniti, 98112
- Group Health Central Hospital
-
Seattle, Washington, Stati Uniti, 98122-4307
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
-
Seattle, Washington, Stati Uniti, 98122
- Polyclinic First Hill
-
Seattle, Washington, Stati Uniti, 98195-6043
- University Cancer Center at University of Washington Medical Center
-
Spokane, Washington, Stati Uniti, 99202
- Cancer Care Northwest - Spokane South
-
Spokane, Washington, Stati Uniti, 99204-2967
- Rockwood Clinic Cancer Treatment Center
-
Spokane, Washington, Stati Uniti, 99204
- Providence Cancer Center at Sacred Heart Medical Center
-
Spokane, Washington, Stati Uniti, 99207
- Providence Cancer Center at Holy Family Hospital
-
Tacoma, Washington, Stati Uniti, 98405
- Allenmore Hospital
-
Tacoma, Washington, Stati Uniti, 98405
- CCOP - Northwest
-
Tacoma, Washington, Stati Uniti, 98405
- MultiCare Regional Cancer Center at Tacoma General Hospital
-
Tacoma, Washington, Stati Uniti, 98499
- St. Clare Hospital
-
Tacoma, Washington, Stati Uniti, 98405-3004
- St. Joseph Medical Center at Franciscan Health System
-
Wenatchee, Washington, Stati Uniti, 98801-2028
- Wenatchee Valley Medical Center
-
-
Wisconsin
-
Appleton, Wisconsin, Stati Uniti, 54911-3496
- Fox Valley Hematology and Oncology - East Grant Street
-
Green Bay, Wisconsin, Stati Uniti, 54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, Stati Uniti, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay, Wisconsin, Stati Uniti, 54303
- St. Mary's Hospital Medical Center - Green Bay
-
Green Bay, Wisconsin, Stati Uniti, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital
-
Janesville, Wisconsin, Stati Uniti, 53547
- Mercy Regional Cancer Center
-
La Crosse, Wisconsin, Stati Uniti, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
-
Manitowoc, Wisconsin, Stati Uniti, 54221-1450
- Holy Family Memorial Medical Center Cancer Care Center
-
Marinette, Wisconsin, Stati Uniti, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
-
Marshfield, Wisconsin, Stati Uniti, 54449
- Marshfield Clinic - Marshfield Center
-
Oconto Falls, Wisconsin, Stati Uniti, 54154
- Green Bay Oncology, Limited - Oconto Falls
-
Racine, Wisconsin, Stati Uniti, 53405
- All Saints Cancer Center at Wheaton Franciscan Healthcare
-
Rice Lake, Wisconsin, Stati Uniti, 54868
- Marshfield Clinic - Indianhead Center
-
Sturgeon Bay, Wisconsin, Stati Uniti, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
-
Wausau, Wisconsin, Stati Uniti, 54401
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
-
-
Wyoming
-
Sheridan, Wyoming, Stati Uniti, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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
|
|
Comparatore attivo: 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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Overall Survival
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Progression-free Survival
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Primo N. Lara, MD, University of California, Davis
- Investigatore principale: Ronald B. Natale, MD, Cedars-Sinai Medical Center
- Investigatore principale: David R. Gandara, MD, University of California, Davis
- Investigatore principale: James R. Jett, MD, Mayo Clinic
- Investigatore principale: Jane Carleton, MD, Don Monti Comprehensive Cancer Center at North Shore University Hospital
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie delle vie respiratorie
- Neoplasie
- Malattie polmonari
- Neoplasie per sede
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Carcinoma, broncogeno
- Neoplasie bronchiali
- Neoplasie polmonari
- Carcinoma polmonare a piccole cellule
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Agenti antineoplastici
- Agenti antineoplastici, fitogenici
- Inibitori della topoisomerasi II
- Inibitori della topoisomerasi
- Inibitori della topoisomerasi I
- Etoposide
- Irinotecano
Altri numeri di identificazione dello studio
- CDR0000256908
- U10CA032102 (Sovvenzione/contratto NIH degli Stati Uniti)
- S0124 (Altro identificatore: CALGB)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Cancro ai polmoni
-
National Cancer Institute (NCI)TerminatoKita-kyushu Lung Cancer Antigen 1, umanoStati Uniti
-
Zeba Ahmad, Ph.D.American Cancer Society, Inc.ReclutamentoCaregiving for CancerStati Uniti
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletatoAdenocarcinoma dell'intestino tenue | Adenocarcinoma dell'intestino tenue in stadio III AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIA AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIB AJCC v8 | Adenocarcinoma dell'intestino tenue stadio IV AJCC v8 | Ampolla di Vater... e altre condizioniStati Uniti
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...CompletatoStudio delle donne cinesi che non hanno aderito alle linee guida per lo screening mammografico dell'American Cancer SocietyStati Uniti
-
Institut Cancerologie de l'OuestAttivo, non reclutanteQualità della vita al lavoro | Professionisti paramedici | Toccare Massaggio | Cancer CenterFrancia
-
Emory UniversityNational Cancer Institute (NCI)RitiratoCancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nel cervello | Carcinoma mammario metastatico | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
-
Yonsei UniversityNon ancora reclutamentoRAS/BRAF Wild-Type Advanced Cancer MathementCorea, Repubblica di
-
NRG OncologyNational Cancer Institute (NCI)CompletatoCancro al seno in stadio anatomico IV AJCC v8 | Cancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nell'osso | Neoplasia maligna metastatica nei linfonodi | Neoplasia maligna metastatica nel fegato | Carcinoma mammario metastatico | Neoplasia maligna metastatica nel... e altre condizioniStati Uniti, Canada, Arabia Saudita, Corea del Sud
-
Jonsson Comprehensive Cancer CenterReclutamentoAdenocarcinoma prostatico | Cancro alla prostata in stadio II AJCC v8 | Fase I Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Jonsson Comprehensive Cancer CenterNovartis PharmaceuticalsReclutamentoCarcinoma della prostata | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
Prove cliniche su cisplatin
-
Second Affiliated Hospital, School of Medicine,...ReclutamentoCarcinoma a cellule squamose del cancro della testa e del colloCina
-
Fudan UniversityNon ancora reclutamento
-
Korea Cancer Center HospitalCompletatoNEOPLASMI CERVICALICorea, Repubblica di
-
AkesoAttivo, non reclutante
-
The First Affiliated Hospital of Xiamen UniversityNon ancora reclutamentoCancro ipofaringeo localmente avanzatoCina
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