- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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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, Verenigde Staten, 36202
- Northeast Alabama Regional Medical Center
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Huntsville, Alabama, Verenigde Staten, 35801
- Huntsville Hospital
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Mobile, Alabama, Verenigde Staten, 36652-2144
- Mobile Infirmary Medical Center
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Opelika, Alabama, Verenigde Staten, 36801-5452
- East Alabama Medical Center
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Alaska
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Anchorage, Alaska, Verenigde Staten, 99508
- Alaska Regional Hospital Cancer Center
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Arizona
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Scottsdale, Arizona, Verenigde Staten, 85259-5499
- Mayo Clinic Scottsdale
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Tucson, Arizona, Verenigde Staten, 85724-5024
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Fort Smith, Arkansas, Verenigde Staten, 72903
- Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
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Little Rock, Arkansas, Verenigde Staten, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Burbank, California, Verenigde Staten, 91505
- Providence Saint Joseph Medical Center - Burbank
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Concord, California, Verenigde Staten, 94524-4110
- Cancer Care Center at John Muir Health - Concord Campus
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Fremont, California, Verenigde Staten, 94538
- Washington Township Hospital
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Fresno, California, Verenigde Staten, 93720
- California Cancer Center - Woodward Park Office
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Los Angeles, California, Verenigde Staten, 90089-9181
- USC/Norris Comprehensive Cancer Center and Hospital
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Palm Springs, California, Verenigde Staten, 92262
- Desert Regional Medical Center Comprehensive Cancer Center
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Redding, California, Verenigde Staten, 96001
- Shasta Regional Medical Center
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Roseville, California, Verenigde Staten, 95661
- Sutter Cancer Center at Roseville Medical Center
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Sacramento, California, Verenigde Staten, 95816
- Sutter Cancer Center
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Sacramento, California, Verenigde Staten, 95817
- University of California Davis Cancer Center
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Santa Rosa, California, Verenigde Staten, 95405
- CCOP - Santa Rosa Memorial Hospital
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Walnut Creek, California, Verenigde Staten, 94598
- John Muir/Mt. Diablo Comprehensive Cancer Center
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Colorado
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Colorado Springs, Colorado, Verenigde Staten, 80909
- Memorial Hospital
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Connecticut
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Norwich, Connecticut, Verenigde Staten, 06360
- Eastern Connecticut Hematology and Oncology Associates
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Florida
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Daytona Beach, Florida, Verenigde Staten, 32115
- Halifax Medical Center - Daytona Beach
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Fort Lauderdale, Florida, Verenigde Staten, 33316
- Broward General Medical Center Cancer Center
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Pensacola, Florida, Verenigde Staten, 32514
- West Florida Cancer Institute at West Florida Hospital - Pensacola
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30309
- Piedmont Hospital
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Atlanta, Georgia, Verenigde Staten, 30342-1611
- Northside Hospital Cancer Center
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Atlanta, Georgia, Verenigde Staten, 30342-1701
- Saint Joseph's Hospital of Atlanta
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Atlanta, Georgia, Verenigde Staten, 30342
- CCOP - Atlanta Regional
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Augusta, Georgia, Verenigde Staten, 30901
- Augusta Oncology Associates - Walton Way
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Austell, Georgia, Verenigde Staten, 30106
- WellStar Cobb Hospital
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Decatur, Georgia, Verenigde Staten, 30033
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
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Lawrenceville, Georgia, Verenigde Staten, 30045
- Gwinnett Medical Center
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Marietta, Georgia, Verenigde Staten, 30060
- Kennestone Cancer Center at Wellstar Kennestone Hospital
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Riverdale, Georgia, Verenigde Staten, 30274-2600
- Southern Regional Medical Center
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Savannah, Georgia, Verenigde Staten, 31403-3089
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Valdosta, Georgia, Verenigde Staten, 31603
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
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Hawaii
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Honolulu, Hawaii, Verenigde Staten, 96859
- Tripler Army Medical Center
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Idaho
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Idaho Falls, Idaho, Verenigde Staten, 83404
- Hematology Oncology Associates of Eastern Idaho
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Illinois
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Alton, Illinois, Verenigde Staten, 62002
- Saint Anthony's Hospital at Saint Anthony's Health Center
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Aurora, Illinois, Verenigde Staten, 60507
- Rush-Copley Cancer Care Center
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Decatur, Illinois, Verenigde Staten, 62526
- Decatur Memorial Hospital Cancer Care Institute
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Elmhurst, Illinois, Verenigde Staten, 60126
- Elmhurst Memorial Hospital
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Hines, Illinois, Verenigde Staten, 60141
- Veterans Affairs Medical Center - Hines
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Joliet, Illinois, Verenigde Staten, 60435
- Joliet Oncology-Hematology Associates, Limited - West
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La Grange, Illinois, Verenigde Staten, 60525
- La Grange Memorial Hospital
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Maywood, Illinois, Verenigde Staten, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Moline, Illinois, Verenigde Staten, 61265
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Moline, Illinois, Verenigde Staten, 61265
- Trinity Medical Center - East
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Mount Vernon, Illinois, Verenigde Staten, 62864
- Good Samaritan Regional Health Center
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River Forest, Illinois, Verenigde Staten, 60305
- West Suburban Center for Cancer Care
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Rockford, Illinois, Verenigde Staten, 61104-2315
- Swedish-American Regional Cancer Center
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Springfield, Illinois, Verenigde Staten, 62781-0001
- Regional Cancer Center at Memorial Medical Center
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Urbana, Illinois, Verenigde Staten, 61801
- Carle Cancer Center at Carle Foundation Hospital
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Urbana, Illinois, Verenigde Staten, 61801
- CCOP - Carle Cancer Center
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Indiana
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Beech Grove, Indiana, Verenigde Staten, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Elkhart, Indiana, Verenigde Staten, 46515
- Elkhart General Hospital
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Kokomo, Indiana, Verenigde Staten, 46904
- Howard Community Hospital at Howard Regional Health System
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La Porte, Indiana, Verenigde Staten, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Michigan City, Indiana, Verenigde Staten, 46360
- Saint Anthony Memorial Health Centers
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Richmond, Indiana, Verenigde Staten, 47374
- Reid Hospital & Health Care Services, Incorporated
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South Bend, Indiana, Verenigde Staten, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Verenigde Staten, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, Verenigde Staten, 46617
- Saint Joseph Regional Medical Center
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Iowa
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Bettendorf, Iowa, Verenigde Staten, 52722
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Bettendorf, Iowa, Verenigde Staten, 52722
- Hematology Oncology Associates of the Quad Cities
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Cedar Rapids, Iowa, Verenigde Staten, 52402
- St. Luke's Hospital
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Cedar Rapids, Iowa, Verenigde Staten, 52403
- Cedar Rapids Oncology Associates
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Cedar Rapids, Iowa, Verenigde Staten, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Council Bluffs, Iowa, Verenigde Staten, 51503
- Heartland Oncology & Hematology
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Davenport, Iowa, Verenigde Staten, 52804
- Genesis Medical Center - West Campus
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Davenport, Iowa, Verenigde Staten, 52803
- Genesis Regional Cancer Center at Genesis Medical Center
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Des Moines, Iowa, Verenigde Staten, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Verenigde Staten, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Verenigde Staten, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Verenigde Staten, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Verenigde Staten, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Verenigde Staten, 50307
- Mercy Capitol Hospital
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Des Moines, Iowa, Verenigde Staten, 50316-2301
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Mason City, Iowa, Verenigde Staten, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
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Ottumwa, Iowa, Verenigde Staten, 52501
- McCreery Cancer Center at Ottumwa Regional
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Sioux City, Iowa, Verenigde Staten, 51101
- Siouxland Regional Cancer Center
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Sioux City, Iowa, Verenigde Staten, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Verenigde Staten, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, Verenigde Staten, 51104
- Mercy Medical Center - Sioux City
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Waterloo, Iowa, Verenigde Staten, 50702
- Covenant Cancer Treatment Center
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Waterloo, Iowa, Verenigde Staten, 50702
- Cedar Valley Medical Specialists, PC - West Ridgeway Avenue
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Kansas
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Chanute, Kansas, Verenigde Staten, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Verenigde Staten, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Verenigde Staten, 67042
- Cancer Center of Kansas, PA - El Dorado
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Kansas City, Kansas, Verenigde Staten, 64128
- Veterans Affairs Medical Center - Kansas City
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Kingman, Kansas, Verenigde Staten, 67068
- Cancer Center of Kansas, PA - Kingman
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Liberal, Kansas, Verenigde Staten, 67901
- Southwest Medical Center
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Newton, Kansas, Verenigde Staten, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Verenigde Staten, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Verenigde Staten, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Verenigde Staten, 67042
- Cancer Center of Kansas, PA - Salina
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Salina, Kansas, Verenigde Staten, 67401
- Tammy Walker Cancer Center at Salina Regional Health Center
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Topeka, Kansas, Verenigde Staten, 66604
- Stormont-Vail Cancer Center
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Wellington, Kansas, Verenigde Staten, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Verenigde Staten, 67203
- Associates in Womens Health, PA - North Review
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Wichita, Kansas, Verenigde Staten, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Verenigde Staten, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Verenigde Staten, 67214
- CCOP - Wichita
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Wichita, Kansas, Verenigde Staten, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Winfield, Kansas, Verenigde Staten, 67156
- Cancer Center of Kansas, PA - Winfield
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Kentucky
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Madisonville, Kentucky, Verenigde Staten, 42431
- Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
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Louisiana
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Alexandria, Louisiana, Verenigde Staten, 71315-3198
- Tulane Cancer Center
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Monroe, Louisiana, Verenigde Staten, 71210
- Louisiana State University Health Sciences Center - Monroe
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Shreveport, Louisiana, Verenigde Staten, 71130-3932
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
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Shreveport, Louisiana, Verenigde Staten, 71101
- Veterans Affairs Medical Center - Shreveport
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Shreveport, Louisiana, Verenigde Staten, 71101
- Christus Schumpert Cancer Treatment Center
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Maine
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Bangor, Maine, Verenigde Staten, 04401
- CancerCare of Maine at Eastern Maine Medial Center
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Waterville, Maine, Verenigde Staten, 04901
- MaineGeneral Medical Center - Waterville Campus
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Massachusetts
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Attleboro, Massachusetts, Verenigde Staten, 02703
- Sturdy Memorial Hospital
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Boston, Massachusetts, Verenigde Staten, 02118
- Cancer Research Center at Boston Medical Center
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Gloucester, Massachusetts, Verenigde Staten, 01930
- Addison Gilbert Hospital
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Worcester, Massachusetts, Verenigde Staten, 01655
- UMASS Memorial Cancer Center - University Campus
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Michigan
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Adrian, Michigan, Verenigde Staten, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, Verenigde Staten, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, Verenigde Staten, 48106
- CCOP - Michigan Cancer Research Consortium
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Battle Creek, Michigan, Verenigde Staten, 49017
- Battle Creek Health System Cancer Care Center
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Big Rapids, Michigan, Verenigde Staten, 49307
- Mecosta County Medical Center
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Detroit, Michigan, Verenigde Staten, 48202
- Josephine Ford Cancer Center at Henry Ford Hospital
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Escanaba, Michigan, Verenigde Staten, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, Verenigde Staten, 48503
- Hurley Medical Center
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Flint, Michigan, Verenigde Staten, 48503
- Genesys Hurley Cancer Institute
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Grand Rapids, Michigan, Verenigde Staten, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, Verenigde Staten, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Grand Rapids, Michigan, Verenigde Staten, 49506
- Metro Health Hospital
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Grand Rapids, Michigan, Verenigde Staten, 49503
- Spectrum Health Hospital - Butterworth Campus
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Grosse Pointe Woods, Michigan, Verenigde Staten, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Holland, Michigan, Verenigde Staten, 49423
- Holland Community Hospital
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Iron Mountain, Michigan, Verenigde Staten, 49801
- Green Bay Oncology, Limited - Iron Mountain
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Jackson, Michigan, Verenigde Staten, 49201
- Foote Hospital
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Kalamazoo, Michigan, Verenigde Staten, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Verenigde Staten, 49001
- Borgess Medical Center
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Kalamazoo, Michigan, Verenigde Staten, 49007-3731
- West Michigan Cancer Center
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Lansing, Michigan, Verenigde Staten, 48909
- Sparrow Regional Cancer Center
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Marquette, Michigan, Verenigde Staten, 49855
- Upper Michigan Cancer Center at Marquette General Hospital
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Midland, Michigan, Verenigde Staten, 48670
- MidMichigan Medical Center - Midland
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Monroe, Michigan, Verenigde Staten, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, Verenigde Staten, 48162
- Mercy Memorial Hospital System
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Mount Clemens, Michigan, Verenigde Staten, 48043
- Ted B. Wahby Cancer Center at Mount Clemens General Hospital
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Muskegon, Michigan, Verenigde Staten, 49442
- Hackley Hospital
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Petoskey, Michigan, Verenigde Staten, 49770
- Northern Michigan Hospital
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Port Huron, Michigan, Verenigde Staten, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Saginaw, Michigan, Verenigde Staten, 48601
- Seton Cancer Institute - Saginaw
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Saint Joseph, Michigan, Verenigde Staten, 49085
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
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Traverse City, Michigan, Verenigde Staten, 49684
- Munson Medical Center
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Warren, Michigan, Verenigde Staten, 48093
- St. John Macomb Hospital
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Minnesota
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Alexandria, Minnesota, Verenigde Staten, 56308
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Bemidji, Minnesota, Verenigde Staten, 56601
- MeritCare Clinic - Bemidji
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Burnsville, Minnesota, Verenigde Staten, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Verenigde Staten, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Verenigde Staten, 55805
- CCOP - Duluth
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Duluth, Minnesota, Verenigde Staten, 55805
- St. Mary's - Duluth Clinic Cancer Center
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Duluth, Minnesota, Verenigde Staten, 55805
- Miller-Dwan Medical Center
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Duluth, Minnesota, Verenigde Staten, 55805
- Cancer Care Center at St. Luke's Hospital
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Edina, Minnesota, Verenigde Staten, 55435
- Fairview Southdale Hospital
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Fergus Falls, Minnesota, Verenigde Staten, 56537
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Fridley, Minnesota, Verenigde Staten, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Verenigde Staten, 55350
- Hutchinson Area Health Care
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Litchfield, Minnesota, Verenigde Staten, 55355
- Meeker County Memorial Hospital
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Mankato, Minnesota, Verenigde Staten, 56002
- Immanuel St. Joseph's Clinic
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Maplewood, Minnesota, Verenigde Staten, 55109
- HealthEast Cancer Care at St. John's Hospital
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Maplewood, Minnesota, Verenigde Staten, 55109
- Minnesota Oncology Hematology, PA at Maplewood Cancer Center
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Minneapolis, Minnesota, Verenigde Staten, 55415
- Hennepin County Medical Center - Minneapolis
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Minneapolis, Minnesota, Verenigde Staten, 55407
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
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Montevideo, Minnesota, Verenigde Staten, 56265
- Chippewa County - Montevideo Hospital
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Robbinsdale, Minnesota, Verenigde Staten, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
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Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Verenigde Staten, 56303
- CentraCare Clinic - River Campus
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Saint Cloud, Minnesota, Verenigde Staten, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, Verenigde Staten, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, Verenigde Staten, 55416
- Park Nicollet Health Services
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Saint Paul, Minnesota, Verenigde Staten, 55102
- St. Joseph's Hospital
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Saint Paul, Minnesota, Verenigde Staten, 55102
- United Hospital
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Saint Paul, Minnesota, Verenigde Staten, 55101
- Regions Hospital Cancer Care Center
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Shakopee, Minnesota, Verenigde Staten, 55379
- Saint Francis Cancer Center
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Waconia, Minnesota, Verenigde Staten, 55387
- Ridgeview Medical Center
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Willmar, Minnesota, Verenigde Staten, 56201
- Willmar Cancer Center at Rice Memorial Hospital
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Woodbury, Minnesota, Verenigde Staten, 55125
- Woodwinds Health Campus
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Woodbury, Minnesota, Verenigde Staten, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Mississippi
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Jackson, Mississippi, Verenigde Staten, 39216
- University of Mississippi Medical Center
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Missouri
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Cape Girardeau, Missouri, Verenigde Staten, 63701
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
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Cape Girardeau, Missouri, Verenigde Staten, 63701
- Saint Francis Medical Center
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Columbia, Missouri, Verenigde Staten, 65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
-
Columbia, Missouri, Verenigde Staten, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Jefferson City, Missouri, Verenigde Staten, 65101
- Capital Region Cancer Center
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Joplin, Missouri, Verenigde Staten, 64804
- Freeman Cancer Institute at Freeman Health System
-
Kansas City, Missouri, Verenigde Staten, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Verenigde Staten, 63131
- Missouri Baptist Cancer Center
-
Saint Louis, Missouri, Verenigde Staten, 63141
- CCOP - St. Louis-Cape Girardeau
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Saint Louis, Missouri, Verenigde Staten, 63141
- David C. Pratt Cancer Center at St. John's Mercy
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Saint Louis, Missouri, Verenigde Staten, 63141
- Arch Medical Services, Incorporated at Center for Cancer Care Research
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Springfield, Missouri, Verenigde Staten, 65802
- CCOP - Cancer Research for the Ozarks
-
Springfield, Missouri, Verenigde Staten, 65804
- St. John's Regional Health Center
-
Springfield, Missouri, Verenigde Staten, 65807
- Hulston Cancer Center at Cox Medical Center South
-
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Montana
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Billings, Montana, Verenigde Staten, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, Verenigde Staten, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Billings, Montana, Verenigde Staten, 59101
- Northern Rockies Radiation Oncology Center
-
Billings, Montana, Verenigde Staten, 59101
- St. Vincent Healthcare
-
Billings, Montana, Verenigde Staten, 59107-5100
- Billings Clinic Cancer Center
-
Billings, Montana, Verenigde Staten, 59107-7000
- Deaconess Billings Clinic - Downtown
-
Bozeman, Montana, Verenigde Staten, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, Verenigde Staten, 59701
- St. James Community Hospital
-
Great Falls, Montana, Verenigde Staten, 59405
- Great Falls Clinic
-
Great Falls, Montana, Verenigde Staten, 59405
-
Great Falls, Montana, Verenigde Staten, 59405
- Big Sky Oncology
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Great Falls, Montana, Verenigde Staten, 59405
- Sletten Regional Cancer Institute at Benefis Healthcare
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Helena, Montana, Verenigde Staten, 59601
- St. Peter's Hospital
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Kalispell, Montana, Verenigde Staten, 59901
- Kalispell Regional Medical Center
-
Kalispell, Montana, Verenigde Staten, 59901
- Glacier Oncology, PLLC
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Kalispell, Montana, Verenigde Staten, 59901
- Kalispell Medical Oncology
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Missoula, Montana, Verenigde Staten, 59801
- Community Medical Center
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Missoula, Montana, Verenigde Staten, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, Verenigde Staten, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, Verenigde Staten, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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Nebraska
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Kearney, Nebraska, Verenigde Staten, 68848-1990
- Good Samaritan Cancer Center at Good Samaritan Hospital
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Lincoln, Nebraska, Verenigde Staten, 68510
- Cancer Resource Center - Lincoln
-
Omaha, Nebraska, Verenigde Staten, 68106
- CCOP - Missouri Valley Cancer Consortium
-
Omaha, Nebraska, Verenigde Staten, 68122
- Immanuel Medical Center
-
Omaha, Nebraska, Verenigde Staten, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
-
Omaha, Nebraska, Verenigde Staten, 68131-2197
- Creighton University Medical Center
-
Omaha, Nebraska, Verenigde Staten, 68114
- Methodist Cancer Center at Methodist Hospital - Omaha
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89102
- University Medical Center of Southern Nevada
-
Las Vegas, Nevada, Verenigde Staten, 89106
- CCOP - Nevada Cancer Research Foundation
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New Jersey
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Flemington, New Jersey, Verenigde Staten, 08822
- Hunterdon Regional Cancer Center at Hunterdon Medical Center
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Morristown, New Jersey, Verenigde Staten, 07962
- Carol G. Simon Cancer Center at Morristown Memorial Hospital
-
Neptune, New Jersey, Verenigde Staten, 07754-0397
- Jersey Shore Cancer Center at Jersey Shore University Medical Center
-
Summit, New Jersey, Verenigde Staten, 07902
- Overlook Hospital
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New York
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Bronx, New York, Verenigde Staten, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
-
Buffalo, New York, Verenigde Staten, 14215
- Veterans Affairs Medical Center - Buffalo
-
Clifton Springs, New York, Verenigde Staten, 14432
- Finger Lakes Hematology and Oncology
-
Glens Falls, New York, Verenigde Staten, 12801
- Adirondack Cancer Care - Glens Falls
-
Manhasset, New York, Verenigde Staten, 11030
- CCOP - North Shore University Hospital
-
Manhasset, New York, Verenigde Staten, 11030
- Don Monti Comprehensive Cancer Center at North Shore University Hospital
-
Middletown, New York, Verenigde Staten, 10940-4199
- Tucker Center for Cancer Care at Orange Regional Medical Center
-
Mineola, New York, Verenigde Staten, 11501
- Winthrop University Hospital
-
New Hyde Park, New York, Verenigde Staten, 11042
- Long Island Jewish Medical Center
-
Rochester, New York, Verenigde Staten, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
-
Rochester, New York, Verenigde Staten, 14623
- Interlakes Oncology/Hematology PC
-
Syracuse, New York, Verenigde Staten, 13210
- SUNY Upstate Medical University Hospital
-
-
North Carolina
-
Goldsboro, North Carolina, Verenigde Staten, 27534
- Wayne Memorial Hospital, Incorporated
-
Kinston, North Carolina, Verenigde Staten, 28501
- Lenoir Memorial Cancer Center
-
Rutherfordton, North Carolina, Verenigde Staten, 28139
- Rutherford Hospital
-
Wilmington, North Carolina, Verenigde Staten, 28401
- Zimmer Cancer Center at New Hanover Regional Medical Center
-
-
North Dakota
-
Bismarck, North Dakota, Verenigde Staten, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, Verenigde Staten, 58501
- Medcenter One Hospital Cancer Care Center
-
Bismarck, North Dakota, Verenigde Staten, 58501
- Mid Dakota Clinic, PC
-
Bismarck, North Dakota, Verenigde Staten, 58502
- St. Alexius Medical Center Cancer Center
-
Fargo, North Dakota, Verenigde Staten, 58122
- CCOP - MeritCare Hospital
-
Fargo, North Dakota, Verenigde Staten, 58122
- MeritCare Broadway
-
Fargo, North Dakota, Verenigde Staten, 58103
- Dakota Cancer Institute at Dakota Clinic - South University
-
-
Ohio
-
Akron, Ohio, Verenigde Staten, 44307
- McDowell Cancer Center at Akron General Medical Center
-
Bowling Green, Ohio, Verenigde Staten, 43402
- Wood County Oncology Center
-
Canton, Ohio, Verenigde Staten, 44708
- Mercy Cancer Center at Mercy Medical Center
-
Chillicothe, Ohio, Verenigde Staten, 45601
- Adena Regional Medical Center
-
Cincinnati, Ohio, Verenigde Staten, 45267
- Charles M. Barrett Cancer Center at University Hospital
-
Cleveland, Ohio, Verenigde Staten, 44195
- Cleveland Clinic Taussig Cancer Center
-
Cleveland, Ohio, Verenigde Staten, 44109
- MetroHealth's Cancer Care Center at MetroHealth Medical Center
-
Columbus, Ohio, Verenigde Staten, 43214-3998
- Riverside Methodist Hospital Cancer Care
-
Columbus, Ohio, Verenigde Staten, 43222
- Mount Carmel Health - West Hospital
-
Columbus, Ohio, Verenigde Staten, 43215
- CCOP - Columbus
-
Columbus, Ohio, Verenigde Staten, 43228
- Doctors Hospital at Ohio Health
-
Columbus, Ohio, Verenigde Staten, 43215
- Grant Riverside Cancer Services
-
Dayton, Ohio, Verenigde Staten, 45428
- Veterans Affairs Medical Center - Dayton
-
Dayton, Ohio, Verenigde Staten, 45405
- Grandview Hospital
-
Dayton, Ohio, Verenigde Staten, 45406
- Good Samaritan Hospital
-
Dayton, Ohio, Verenigde Staten, 45415
- Samaritan North Cancer Care Center
-
Dayton, Ohio, Verenigde Staten, 45429
- CCOP - Dayton
-
Delaware, Ohio, Verenigde Staten, 43015
- Grady Memorial Hospital
-
Findlay, Ohio, Verenigde Staten, 45840
- Blanchard Valley Medical Associates
-
Fremont, Ohio, Verenigde Staten, 43420
- Fremont Memorial Hospital
-
Independence, Ohio, Verenigde Staten, 44131
- Community Oncology Group at Cleveland Clinic Cancer Center
-
Kenton, Ohio, Verenigde Staten, 43326
- Kenton Oncology, Incorporated
-
Kettering, Ohio, Verenigde Staten, 45429
- Charles F. Kettering Memorial Hospital
-
Lancaster, Ohio, Verenigde Staten, 43130
- Fairfield Medical Center
-
Lima, Ohio, Verenigde Staten, 45804
- Lima Memorial Hospital
-
Lima, Ohio, Verenigde Staten, 45801
- St. Rita's Medical Center
-
Mansfield, Ohio, Verenigde Staten, 44903
- MedCentral - Mansfield Hospital
-
Marietta, Ohio, Verenigde Staten, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
-
Maumee, Ohio, Verenigde Staten, 43537
- St. Luke's Hospital
-
Maumee, Ohio, Verenigde Staten, 43623
- Northwest Ohio Oncology Center
-
Middletown, Ohio, Verenigde Staten, 45044
- Middletown Regional Hospital
-
Newark, Ohio, Verenigde Staten, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
-
Oregon, Ohio, Verenigde Staten, 43616
- St. Charles Mercy Hospital
-
Oregon, Ohio, Verenigde Staten, 43616
- Toledo Clinic - Oregon
-
Sandusky, Ohio, Verenigde Staten, 44870
- Firelands Regional Medical Center
-
Sandusky, Ohio, Verenigde Staten, 44870
- North Coast Cancer Care, Incorporated
-
Springfield, Ohio, Verenigde Staten, 45505
- Community Hospital of Springfield and Clark County
-
Springfield, Ohio, Verenigde Staten, 45504
- Mercy Medical Center
-
Sylvania, Ohio, Verenigde Staten, 43560
- Flower Hospital Cancer Center
-
Toledo, Ohio, Verenigde Staten, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, Verenigde Staten, 43606
- Toledo Hospital
-
Toledo, Ohio, Verenigde Staten, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, Verenigde Staten, 43617
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, Verenigde Staten, 43623
- Toledo Clinic, Incorporated - Main Clinic
-
Troy, Ohio, Verenigde Staten, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Wauseon, Ohio, Verenigde Staten, 43567
- Fulton County Health Center
-
Westerville, Ohio, Verenigde Staten, 43081
- Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
-
Wooster, Ohio, Verenigde Staten, 44691
- Cleveland Clinic - Wooster
-
Xenia, Ohio, Verenigde Staten, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
-
Youngstown, Ohio, Verenigde Staten, 44501
- Tod Children's Hospital - Forum Health
-
Zanesville, Ohio, Verenigde Staten, 43701
- Genesis - Good Samaritan Hospital
-
-
Oregon
-
Klamath Falls, Oregon, Verenigde Staten, 97601
- Merle West Medical Center Cancer Treatment Center
-
Portland, Oregon, Verenigde Staten, 97207
- Veterans Affairs Medical Center - Portland
-
Portland, Oregon, Verenigde Staten, 97239-3098
- Oregon Health & Science University Cancer Institute
-
Portland, Oregon, Verenigde Staten, 97232
- Kaiser Permanente Health Care - Portland
-
Salem, Oregon, Verenigde Staten, 97309-5014
- Salem Hospital Regional Cancer Care Services
-
-
Pennsylvania
-
Allentown, Pennsylvania, Verenigde Staten, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
-
Danville, Pennsylvania, Verenigde Staten, 17822-0001
- Geisinger Medical Center
-
DuBois, Pennsylvania, Verenigde Staten, 15801
- Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center
-
Easton, Pennsylvania, Verenigde Staten, 18042
- Easton Regional Cancer Center at Easton Hospital
-
Harrisburg, Pennsylvania, Verenigde Staten, 17105
- PinnacleHealth Regional Cancer Center at Polyclinic Hospital
-
Lancaster, Pennsylvania, Verenigde Staten, 17604
- Lancaster General Hospital
-
Langhorne, Pennsylvania, Verenigde Staten, 19047
- St. Mary Regional Cancer Center
-
Pittsburgh, Pennsylvania, Verenigde Staten, 15212
- Allegheny Cancer Center at Allegheny General Hospital
-
Scranton, Pennsylvania, Verenigde Staten, 18501
- Mercy Hospital Cancer Center - Scranton
-
Scranton, Pennsylvania, Verenigde Staten, 18510
- Hematology and Oncology Associates of Northeastern Pennsylvania
-
State College, Pennsylvania, Verenigde Staten, 16801
- Geisinger Medical Group - Scenery Park
-
Wilkes-Barre, Pennsylvania, Verenigde Staten, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
-
-
South Carolina
-
Anderson, South Carolina, Verenigde Staten, 29621
- AnMed Cancer Center
-
Charleston, South Carolina, Verenigde Staten, 29425
- Hollings Cancer Center at Medical University of South Carolina
-
Greenville, South Carolina, Verenigde Staten, 29615
- CCOP - Greenville
-
Greenville, South Carolina, Verenigde Staten, 29601
- Bon Secours St. Francis Health System
-
Spartanburg, South Carolina, Verenigde Staten, 29303
- CCOP - Upstate Carolina
-
Spartanburg, South Carolina, Verenigde Staten, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
-
-
South Dakota
-
Rapid City, South Dakota, Verenigde Staten, 57701
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, Verenigde Staten, 57105
- Avera Cancer Institute
-
Sioux Falls, South Dakota, Verenigde Staten, 57117-5039
- Sioux Valley Hospital and University of South Dakota Medical Center
-
Sioux Falls, South Dakota, Verenigde Staten, 57105
- Medical X-Ray Center, PC
-
-
Tennessee
-
Knoxville, Tennessee, Verenigde Staten, 37916
- Thompson Cancer Survival Center
-
Knoxville, Tennessee, Verenigde Staten, 37920-6999
- U.T. Cancer Institute at University of Tennessee Medical Center
-
Memphis, Tennessee, Verenigde Staten, 38104
- University of Tennessee Cancer Institute - Medical Center
-
-
Texas
-
Dallas, Texas, Verenigde Staten, 75230
- Medical City Dallas Hospital
-
Fort Sam Houston, Texas, Verenigde Staten, 78234
- Brooke Army Medical Center
-
Houston, Texas, Verenigde Staten, 77030
- Ben Taub General Hospital
-
Houston, Texas, Verenigde Staten, 77030
- Methodist Hospital
-
Houston, Texas, Verenigde Staten, 77030
- Veterans Affairs Medical Center - Houston
-
Houston, Texas, Verenigde Staten, 77030
- Baylor University Medical Center - Houston
-
Houston, Texas, Verenigde Staten, 77030
- St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
-
Lackland Air Force Base, Texas, Verenigde Staten, 78236
- Wilford Hall Medical Center
-
Lubbock, Texas, Verenigde Staten, 79415-3364
- UMC Southwest Cancer and Research Center
-
San Antonio, Texas, Verenigde Staten, 78229
- Cancer Therapy and Research Center
-
San Antonio, Texas, Verenigde Staten, 78209
- Veterans Affairs Medical Center - San Antonio (Murphy)
-
San Antonio, Texas, Verenigde Staten, 78229-3900
- University of Texas Health Science Center at San Antonio
-
San Antonio, Texas, Verenigde Staten, 78229
- University Hospital - San Antonio
-
Temple, Texas, Verenigde Staten, 76508
- CCOP - Scott and White Hospital
-
-
Utah
-
American Fork, Utah, Verenigde Staten, 84003
- American Fork Hospital
-
Logan, Utah, Verenigde Staten, 84321
- Logan Regional Hospital
-
Murray, Utah, Verenigde Staten, 84107
- Cottonwood Hospital Medical Center
-
Ogden, Utah, Verenigde Staten, 84403
- McKay-Dee Hospital Center
-
Provo, Utah, Verenigde Staten, 84604
- Utah Valley Regional Medical Center - Provo
-
Saint George, Utah, Verenigde Staten, 84770
- Dixie Regional Medical Center - East Campus
-
Salt Lake City, Utah, Verenigde Staten, 84112
- Huntsman Cancer Institute at University of Utah
-
Salt Lake City, Utah, Verenigde Staten, 84106
- Utah Cancer Specialists at UCS Cancer Center
-
Salt Lake City, Utah, Verenigde Staten, 84143
- Latter Day Saints Hospital
-
-
Virginia
-
Charlottesville, Virginia, Verenigde Staten, 22901
- Martha Jefferson Hospital Cancer Care Center
-
Danville, Virginia, Verenigde Staten, 24541
- Danville Regional Medical Center
-
Lynchburg, Virginia, Verenigde Staten, 24501
- Lynchburg Hematology-Oncology Clinic
-
Newport News, Virginia, Verenigde Staten, 23601
- Peninsula Cancer Institute - Newport News Office
-
Richmond, Virginia, Verenigde Staten, 23249
- Veterans Affairs Medical Center - Richmond
-
-
Washington
-
Auburn, Washington, Verenigde Staten, 98002
- Auburn Regional Center for Cancer Care
-
Bellingham, Washington, Verenigde Staten, 98225
- St. Joseph Cancer Center
-
Bremerton, Washington, Verenigde Staten, 98310
- Olympic Hematology and Oncology
-
Centralia, Washington, Verenigde Staten, 98531-9027
- Providence Centralia Hospital Regional Cancer Center
-
Federal Way, Washington, Verenigde Staten, 98003
- St. Francis Hospital
-
Mount Vernon, Washington, Verenigde Staten, 98273
- Skagit Valley Hospital Cancer Care Center
-
Olympia, Washington, Verenigde Staten, 98506-5166
- Providence St. Peter Hospital Regional Cancer Center
-
Puyallup, Washington, Verenigde Staten, 98372
- Good Samaritan Cancer Center
-
Seattle, Washington, Verenigde Staten, 98104
- Harborview Medical Center
-
Seattle, Washington, Verenigde Staten, 98104
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, Verenigde Staten, 98104
- Minor and James Medical, PLLC
-
Seattle, Washington, Verenigde Staten, 98112
- Group Health Central Hospital
-
Seattle, Washington, Verenigde Staten, 98122-4307
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
-
Seattle, Washington, Verenigde Staten, 98122
- Polyclinic First Hill
-
Seattle, Washington, Verenigde Staten, 98195-6043
- University Cancer Center at University of Washington Medical Center
-
Spokane, Washington, Verenigde Staten, 99202
- Cancer Care Northwest - Spokane South
-
Spokane, Washington, Verenigde Staten, 99204-2967
- Rockwood Clinic Cancer Treatment Center
-
Spokane, Washington, Verenigde Staten, 99204
- Providence Cancer Center at Sacred Heart Medical Center
-
Spokane, Washington, Verenigde Staten, 99207
- Providence Cancer Center at Holy Family Hospital
-
Tacoma, Washington, Verenigde Staten, 98405
- Allenmore Hospital
-
Tacoma, Washington, Verenigde Staten, 98405
- CCOP - Northwest
-
Tacoma, Washington, Verenigde Staten, 98405
- MultiCare Regional Cancer Center at Tacoma General Hospital
-
Tacoma, Washington, Verenigde Staten, 98499
- St. Clare Hospital
-
Tacoma, Washington, Verenigde Staten, 98405-3004
- St. Joseph Medical Center at Franciscan Health System
-
Wenatchee, Washington, Verenigde Staten, 98801-2028
- Wenatchee Valley Medical Center
-
-
Wisconsin
-
Appleton, Wisconsin, Verenigde Staten, 54911-3496
- Fox Valley Hematology and Oncology - East Grant Street
-
Green Bay, Wisconsin, Verenigde Staten, 54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, Verenigde Staten, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay, Wisconsin, Verenigde Staten, 54303
- St. Mary's Hospital Medical Center - Green Bay
-
Green Bay, Wisconsin, Verenigde Staten, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital
-
Janesville, Wisconsin, Verenigde Staten, 53547
- Mercy Regional Cancer Center
-
La Crosse, Wisconsin, Verenigde Staten, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
-
Manitowoc, Wisconsin, Verenigde Staten, 54221-1450
- Holy Family Memorial Medical Center Cancer Care Center
-
Marinette, Wisconsin, Verenigde Staten, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
-
Marshfield, Wisconsin, Verenigde Staten, 54449
- Marshfield Clinic - Marshfield Center
-
Oconto Falls, Wisconsin, Verenigde Staten, 54154
- Green Bay Oncology, Limited - Oconto Falls
-
Racine, Wisconsin, Verenigde Staten, 53405
- All Saints Cancer Center at Wheaton Franciscan Healthcare
-
Rice Lake, Wisconsin, Verenigde Staten, 54868
- Marshfield Clinic - Indianhead Center
-
Sturgeon Bay, Wisconsin, Verenigde Staten, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
-
Wausau, Wisconsin, Verenigde Staten, 54401
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
-
-
Wyoming
-
Sheridan, Wyoming, Verenigde Staten, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: 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
|
|
Actieve vergelijker: 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Overall Survival
Tijdsspanne: 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.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Progression-free Survival
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Primo N. Lara, MD, University of California, Davis
- Hoofdonderzoeker: Ronald B. Natale, MD, Cedars-Sinai Medical Center
- Hoofdonderzoeker: David R. Gandara, MD, University of California, Davis
- Hoofdonderzoeker: James R. Jett, MD, Mayo Clinic
- Hoofdonderzoeker: Jane Carleton, MD, Don Monti Comprehensive Cancer Center at North Shore University Hospital
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van de luchtwegen
- Neoplasmata
- Longziekten
- Neoplasmata per site
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Carcinoom, bronchogeen
- Bronchiale neoplasmata
- Longneoplasmata
- Kleincellig longcarcinoom
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Antineoplastische middelen, fytogeen
- Topoisomerase II-remmers
- Topoisomeraseremmers
- Topoisomerase I-remmers
- Etoposide
- Irinotecan
Andere studie-ID-nummers
- CDR0000256908
- U10CA032102 (Subsidie/contract van de Amerikaanse NIH)
- S0124 (Andere identificatie: CALGB)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .