S0124: Cisplatin Combined With Irinotecan or Etoposide For Extensive-Stage Small Cell Lung Cancer
3 juli 2018 uppdaterad av: Southwest Oncology Group
Randomized Phase III Trial of Cisplatin and Irinotecan (NSC-616348) Versus Cisplatin and Etoposide in Patients With Extensive Stage Small Cell Lung Cancer (E-SCLC)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether cisplatin combined with irinotecan is more effective than cisplatin combined with etoposide in treating extensive-stage small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin combined with either irinotecan or etoposide in treating patients who have extensive-stage small cell lung cancer.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
671
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Anniston, Alabama, Förenta staterna, 36202
- Northeast Alabama Regional Medical Center
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Huntsville, Alabama, Förenta staterna, 35801
- Huntsville Hospital
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Mobile, Alabama, Förenta staterna, 36652-2144
- Mobile Infirmary Medical Center
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Opelika, Alabama, Förenta staterna, 36801-5452
- East Alabama Medical Center
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Alaska
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Anchorage, Alaska, Förenta staterna, 99508
- Alaska Regional Hospital Cancer Center
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Arizona
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Scottsdale, Arizona, Förenta staterna, 85259-5499
- Mayo Clinic Scottsdale
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Tucson, Arizona, Förenta staterna, 85724-5024
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Fort Smith, Arkansas, Förenta staterna, 72903
- Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
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Little Rock, Arkansas, Förenta staterna, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Burbank, California, Förenta staterna, 91505
- Providence Saint Joseph Medical Center - Burbank
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Concord, California, Förenta staterna, 94524-4110
- Cancer Care Center at John Muir Health - Concord Campus
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Fremont, California, Förenta staterna, 94538
- Washington Township Hospital
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Fresno, California, Förenta staterna, 93720
- California Cancer Center - Woodward Park Office
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Los Angeles, California, Förenta staterna, 90089-9181
- USC/Norris Comprehensive Cancer Center and Hospital
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Palm Springs, California, Förenta staterna, 92262
- Desert Regional Medical Center Comprehensive Cancer Center
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Redding, California, Förenta staterna, 96001
- Shasta Regional Medical Center
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Roseville, California, Förenta staterna, 95661
- Sutter Cancer Center at Roseville Medical Center
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Sacramento, California, Förenta staterna, 95816
- Sutter Cancer Center
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Sacramento, California, Förenta staterna, 95817
- University of California Davis Cancer Center
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Santa Rosa, California, Förenta staterna, 95405
- CCOP - Santa Rosa Memorial Hospital
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Walnut Creek, California, Förenta staterna, 94598
- John Muir/Mt. Diablo Comprehensive Cancer Center
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Colorado
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Colorado Springs, Colorado, Förenta staterna, 80909
- Memorial Hospital
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Connecticut
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Norwich, Connecticut, Förenta staterna, 06360
- Eastern Connecticut Hematology and Oncology Associates
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Florida
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Daytona Beach, Florida, Förenta staterna, 32115
- Halifax Medical Center - Daytona Beach
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Fort Lauderdale, Florida, Förenta staterna, 33316
- Broward General Medical Center Cancer Center
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Pensacola, Florida, Förenta staterna, 32514
- West Florida Cancer Institute at West Florida Hospital - Pensacola
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Georgia
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Atlanta, Georgia, Förenta staterna, 30309
- Piedmont Hospital
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Atlanta, Georgia, Förenta staterna, 30342-1611
- Northside Hospital Cancer Center
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Atlanta, Georgia, Förenta staterna, 30342-1701
- Saint Joseph's Hospital of Atlanta
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Atlanta, Georgia, Förenta staterna, 30342
- CCOP - Atlanta Regional
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Augusta, Georgia, Förenta staterna, 30901
- Augusta Oncology Associates - Walton Way
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Austell, Georgia, Förenta staterna, 30106
- WellStar Cobb Hospital
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Decatur, Georgia, Förenta staterna, 30033
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
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Lawrenceville, Georgia, Förenta staterna, 30045
- Gwinnett Medical Center
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Marietta, Georgia, Förenta staterna, 30060
- Kennestone Cancer Center at Wellstar Kennestone Hospital
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Riverdale, Georgia, Förenta staterna, 30274-2600
- Southern Regional Medical Center
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Savannah, Georgia, Förenta staterna, 31403-3089
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Valdosta, Georgia, Förenta staterna, 31603
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
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Hawaii
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Honolulu, Hawaii, Förenta staterna, 96859
- Tripler Army Medical Center
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Idaho
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Idaho Falls, Idaho, Förenta staterna, 83404
- Hematology Oncology Associates of Eastern Idaho
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Illinois
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Alton, Illinois, Förenta staterna, 62002
- Saint Anthony's Hospital at Saint Anthony's Health Center
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Aurora, Illinois, Förenta staterna, 60507
- Rush-Copley Cancer Care Center
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Decatur, Illinois, Förenta staterna, 62526
- Decatur Memorial Hospital Cancer Care Institute
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Elmhurst, Illinois, Förenta staterna, 60126
- Elmhurst Memorial Hospital
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Hines, Illinois, Förenta staterna, 60141
- Veterans Affairs Medical Center - Hines
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Joliet, Illinois, Förenta staterna, 60435
- Joliet Oncology-Hematology Associates, Limited - West
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La Grange, Illinois, Förenta staterna, 60525
- La Grange Memorial Hospital
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Maywood, Illinois, Förenta staterna, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Moline, Illinois, Förenta staterna, 61265
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Moline, Illinois, Förenta staterna, 61265
- Trinity Medical Center - East
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Mount Vernon, Illinois, Förenta staterna, 62864
- Good Samaritan Regional Health Center
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River Forest, Illinois, Förenta staterna, 60305
- West Suburban Center for Cancer Care
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Rockford, Illinois, Förenta staterna, 61104-2315
- Swedish-American Regional Cancer Center
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Springfield, Illinois, Förenta staterna, 62781-0001
- Regional Cancer Center at Memorial Medical Center
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Urbana, Illinois, Förenta staterna, 61801
- Carle Cancer Center at Carle Foundation Hospital
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Urbana, Illinois, Förenta staterna, 61801
- CCOP - Carle Cancer Center
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Indiana
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Beech Grove, Indiana, Förenta staterna, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Elkhart, Indiana, Förenta staterna, 46515
- Elkhart General Hospital
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Kokomo, Indiana, Förenta staterna, 46904
- Howard Community Hospital at Howard Regional Health System
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La Porte, Indiana, Förenta staterna, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Michigan City, Indiana, Förenta staterna, 46360
- Saint Anthony Memorial Health Centers
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Richmond, Indiana, Förenta staterna, 47374
- Reid Hospital & Health Care Services, Incorporated
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South Bend, Indiana, Förenta staterna, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Förenta staterna, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, Förenta staterna, 46617
- Saint Joseph Regional Medical Center
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Iowa
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Bettendorf, Iowa, Förenta staterna, 52722
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Bettendorf, Iowa, Förenta staterna, 52722
- Hematology Oncology Associates of the Quad Cities
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Cedar Rapids, Iowa, Förenta staterna, 52402
- St. Luke's Hospital
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Cedar Rapids, Iowa, Förenta staterna, 52403
- Cedar Rapids Oncology Associates
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Cedar Rapids, Iowa, Förenta staterna, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Council Bluffs, Iowa, Förenta staterna, 51503
- Heartland Oncology & Hematology
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Davenport, Iowa, Förenta staterna, 52804
- Genesis Medical Center - West Campus
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Davenport, Iowa, Förenta staterna, 52803
- Genesis Regional Cancer Center at Genesis Medical Center
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Des Moines, Iowa, Förenta staterna, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Förenta staterna, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Förenta staterna, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Förenta staterna, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Förenta staterna, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Förenta staterna, 50307
- Mercy Capitol Hospital
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Des Moines, Iowa, Förenta staterna, 50316-2301
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Mason City, Iowa, Förenta staterna, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
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Ottumwa, Iowa, Förenta staterna, 52501
- McCreery Cancer Center at Ottumwa Regional
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Sioux City, Iowa, Förenta staterna, 51101
- Siouxland Regional Cancer Center
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Sioux City, Iowa, Förenta staterna, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Förenta staterna, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, Förenta staterna, 51104
- Mercy Medical Center - Sioux City
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Waterloo, Iowa, Förenta staterna, 50702
- Covenant Cancer Treatment Center
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Waterloo, Iowa, Förenta staterna, 50702
- Cedar Valley Medical Specialists, PC - West Ridgeway Avenue
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Kansas
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Chanute, Kansas, Förenta staterna, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Förenta staterna, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Förenta staterna, 67042
- Cancer Center of Kansas, PA - El Dorado
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Kansas City, Kansas, Förenta staterna, 64128
- Veterans Affairs Medical Center - Kansas City
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Kingman, Kansas, Förenta staterna, 67068
- Cancer Center of Kansas, PA - Kingman
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Liberal, Kansas, Förenta staterna, 67901
- Southwest Medical Center
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Newton, Kansas, Förenta staterna, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Förenta staterna, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Förenta staterna, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Förenta staterna, 67042
- Cancer Center of Kansas, PA - Salina
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Salina, Kansas, Förenta staterna, 67401
- Tammy Walker Cancer Center at Salina Regional Health Center
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Topeka, Kansas, Förenta staterna, 66604
- Stormont-Vail Cancer Center
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Wellington, Kansas, Förenta staterna, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Förenta staterna, 67203
- Associates in Womens Health, PA - North Review
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Wichita, Kansas, Förenta staterna, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Förenta staterna, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Förenta staterna, 67214
- CCOP - Wichita
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Wichita, Kansas, Förenta staterna, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Winfield, Kansas, Förenta staterna, 67156
- Cancer Center of Kansas, PA - Winfield
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Kentucky
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Madisonville, Kentucky, Förenta staterna, 42431
- Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
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Louisiana
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Alexandria, Louisiana, Förenta staterna, 71315-3198
- Tulane Cancer Center
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Monroe, Louisiana, Förenta staterna, 71210
- Louisiana State University Health Sciences Center - Monroe
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Shreveport, Louisiana, Förenta staterna, 71130-3932
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
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Shreveport, Louisiana, Förenta staterna, 71101
- Veterans Affairs Medical Center - Shreveport
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Shreveport, Louisiana, Förenta staterna, 71101
- Christus Schumpert Cancer Treatment Center
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Maine
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Bangor, Maine, Förenta staterna, 04401
- CancerCare of Maine at Eastern Maine Medial Center
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Waterville, Maine, Förenta staterna, 04901
- MaineGeneral Medical Center - Waterville Campus
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Massachusetts
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Attleboro, Massachusetts, Förenta staterna, 02703
- Sturdy Memorial Hospital
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Boston, Massachusetts, Förenta staterna, 02118
- Cancer Research Center at Boston Medical Center
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Gloucester, Massachusetts, Förenta staterna, 01930
- Addison Gilbert Hospital
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Worcester, Massachusetts, Förenta staterna, 01655
- UMASS Memorial Cancer Center - University Campus
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Michigan
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Adrian, Michigan, Förenta staterna, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, Förenta staterna, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, Förenta staterna, 48106
- CCOP - Michigan Cancer Research Consortium
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Battle Creek, Michigan, Förenta staterna, 49017
- Battle Creek Health System Cancer Care Center
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Big Rapids, Michigan, Förenta staterna, 49307
- Mecosta County Medical Center
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Detroit, Michigan, Förenta staterna, 48202
- Josephine Ford Cancer Center at Henry Ford Hospital
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Escanaba, Michigan, Förenta staterna, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, Förenta staterna, 48503
- Hurley Medical Center
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Flint, Michigan, Förenta staterna, 48503
- Genesys Hurley Cancer Institute
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Grand Rapids, Michigan, Förenta staterna, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, Förenta staterna, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Grand Rapids, Michigan, Förenta staterna, 49506
- Metro Health Hospital
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Grand Rapids, Michigan, Förenta staterna, 49503
- Spectrum Health Hospital - Butterworth Campus
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Grosse Pointe Woods, Michigan, Förenta staterna, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Holland, Michigan, Förenta staterna, 49423
- Holland Community Hospital
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Iron Mountain, Michigan, Förenta staterna, 49801
- Green Bay Oncology, Limited - Iron Mountain
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Jackson, Michigan, Förenta staterna, 49201
- Foote Hospital
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Kalamazoo, Michigan, Förenta staterna, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Förenta staterna, 49001
- Borgess Medical Center
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Kalamazoo, Michigan, Förenta staterna, 49007-3731
- West Michigan Cancer Center
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Lansing, Michigan, Förenta staterna, 48909
- Sparrow Regional Cancer Center
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Marquette, Michigan, Förenta staterna, 49855
- Upper Michigan Cancer Center at Marquette General Hospital
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Midland, Michigan, Förenta staterna, 48670
- MidMichigan Medical Center - Midland
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Monroe, Michigan, Förenta staterna, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, Förenta staterna, 48162
- Mercy Memorial Hospital System
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Mount Clemens, Michigan, Förenta staterna, 48043
- Ted B. Wahby Cancer Center at Mount Clemens General Hospital
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Muskegon, Michigan, Förenta staterna, 49442
- Hackley Hospital
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Petoskey, Michigan, Förenta staterna, 49770
- Northern Michigan Hospital
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Port Huron, Michigan, Förenta staterna, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Saginaw, Michigan, Förenta staterna, 48601
- Seton Cancer Institute - Saginaw
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Saint Joseph, Michigan, Förenta staterna, 49085
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
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Traverse City, Michigan, Förenta staterna, 49684
- Munson Medical Center
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Warren, Michigan, Förenta staterna, 48093
- St. John Macomb Hospital
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Minnesota
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Alexandria, Minnesota, Förenta staterna, 56308
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Bemidji, Minnesota, Förenta staterna, 56601
- MeritCare Clinic - Bemidji
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Burnsville, Minnesota, Förenta staterna, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Förenta staterna, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Förenta staterna, 55805
- CCOP - Duluth
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Duluth, Minnesota, Förenta staterna, 55805
- St. Mary's - Duluth Clinic Cancer Center
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Duluth, Minnesota, Förenta staterna, 55805
- Miller-Dwan Medical Center
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Duluth, Minnesota, Förenta staterna, 55805
- Cancer Care Center at St. Luke's Hospital
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Edina, Minnesota, Förenta staterna, 55435
- Fairview Southdale Hospital
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Fergus Falls, Minnesota, Förenta staterna, 56537
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Fridley, Minnesota, Förenta staterna, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Förenta staterna, 55350
- Hutchinson Area Health Care
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Litchfield, Minnesota, Förenta staterna, 55355
- Meeker County Memorial Hospital
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Mankato, Minnesota, Förenta staterna, 56002
- Immanuel St. Joseph's Clinic
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Maplewood, Minnesota, Förenta staterna, 55109
- HealthEast Cancer Care at St. John's Hospital
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Maplewood, Minnesota, Förenta staterna, 55109
- Minnesota Oncology Hematology, PA at Maplewood Cancer Center
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Minneapolis, Minnesota, Förenta staterna, 55415
- Hennepin County Medical Center - Minneapolis
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Minneapolis, Minnesota, Förenta staterna, 55407
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
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Montevideo, Minnesota, Förenta staterna, 56265
- Chippewa County - Montevideo Hospital
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Robbinsdale, Minnesota, Förenta staterna, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Förenta staterna, 56303
- CentraCare Clinic - River Campus
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Saint Cloud, Minnesota, Förenta staterna, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, Förenta staterna, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, Förenta staterna, 55416
- Park Nicollet Health Services
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Saint Paul, Minnesota, Förenta staterna, 55102
- St. Joseph's Hospital
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Saint Paul, Minnesota, Förenta staterna, 55102
- United Hospital
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Saint Paul, Minnesota, Förenta staterna, 55101
- Regions Hospital Cancer Care Center
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Shakopee, Minnesota, Förenta staterna, 55379
- Saint Francis Cancer Center
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Waconia, Minnesota, Förenta staterna, 55387
- Ridgeview Medical Center
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Willmar, Minnesota, Förenta staterna, 56201
- Willmar Cancer Center at Rice Memorial Hospital
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Woodbury, Minnesota, Förenta staterna, 55125
- Woodwinds Health Campus
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Woodbury, Minnesota, Förenta staterna, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Mississippi
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Jackson, Mississippi, Förenta staterna, 39216
- University of Mississippi Medical Center
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Missouri
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Cape Girardeau, Missouri, Förenta staterna, 63701
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
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Cape Girardeau, Missouri, Förenta staterna, 63701
- Saint Francis Medical Center
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Columbia, Missouri, Förenta staterna, 65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
-
Columbia, Missouri, Förenta staterna, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Jefferson City, Missouri, Förenta staterna, 65101
- Capital Region Cancer Center
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Joplin, Missouri, Förenta staterna, 64804
- Freeman Cancer Institute at Freeman Health System
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Kansas City, Missouri, Förenta staterna, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Förenta staterna, 63131
- Missouri Baptist Cancer Center
-
Saint Louis, Missouri, Förenta staterna, 63141
- CCOP - St. Louis-Cape Girardeau
-
Saint Louis, Missouri, Förenta staterna, 63141
- David C. Pratt Cancer Center at St. John's Mercy
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Saint Louis, Missouri, Förenta staterna, 63141
- Arch Medical Services, Incorporated at Center for Cancer Care Research
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Springfield, Missouri, Förenta staterna, 65802
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, Förenta staterna, 65804
- St. John's Regional Health Center
-
Springfield, Missouri, Förenta staterna, 65807
- Hulston Cancer Center at Cox Medical Center South
-
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Montana
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Billings, Montana, Förenta staterna, 59101
- CCOP - Montana Cancer Consortium
-
Billings, Montana, Förenta staterna, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
-
Billings, Montana, Förenta staterna, 59101
- Northern Rockies Radiation Oncology Center
-
Billings, Montana, Förenta staterna, 59101
- St. Vincent Healthcare
-
Billings, Montana, Förenta staterna, 59107-5100
- Billings Clinic Cancer Center
-
Billings, Montana, Förenta staterna, 59107-7000
- Deaconess Billings Clinic - Downtown
-
Bozeman, Montana, Förenta staterna, 59715
- Bozeman Deaconess Cancer Center
-
Butte, Montana, Förenta staterna, 59701
- St. James Community Hospital
-
Great Falls, Montana, Förenta staterna, 59405
- Great Falls Clinic
-
Great Falls, Montana, Förenta staterna, 59405
-
Great Falls, Montana, Förenta staterna, 59405
- Big Sky Oncology
-
Great Falls, Montana, Förenta staterna, 59405
- Sletten Regional Cancer Institute at Benefis Healthcare
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Helena, Montana, Förenta staterna, 59601
- St. Peter's Hospital
-
Kalispell, Montana, Förenta staterna, 59901
- Kalispell Regional Medical Center
-
Kalispell, Montana, Förenta staterna, 59901
- Glacier Oncology, PLLC
-
Kalispell, Montana, Förenta staterna, 59901
- Kalispell Medical Oncology
-
Missoula, Montana, Förenta staterna, 59801
- Community Medical Center
-
Missoula, Montana, Förenta staterna, 59804
- Guardian Oncology and Center for Wellness
-
Missoula, Montana, Förenta staterna, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
-
Missoula, Montana, Förenta staterna, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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Nebraska
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Kearney, Nebraska, Förenta staterna, 68848-1990
- Good Samaritan Cancer Center at Good Samaritan Hospital
-
Lincoln, Nebraska, Förenta staterna, 68510
- Cancer Resource Center - Lincoln
-
Omaha, Nebraska, Förenta staterna, 68106
- CCOP - Missouri Valley Cancer Consortium
-
Omaha, Nebraska, Förenta staterna, 68122
- Immanuel Medical Center
-
Omaha, Nebraska, Förenta staterna, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
-
Omaha, Nebraska, Förenta staterna, 68131-2197
- Creighton University Medical Center
-
Omaha, Nebraska, Förenta staterna, 68114
- Methodist Cancer Center at Methodist Hospital - Omaha
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89102
- University Medical Center of Southern Nevada
-
Las Vegas, Nevada, Förenta staterna, 89106
- CCOP - Nevada Cancer Research Foundation
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New Jersey
-
Flemington, New Jersey, Förenta staterna, 08822
- Hunterdon Regional Cancer Center at Hunterdon Medical Center
-
Morristown, New Jersey, Förenta staterna, 07962
- Carol G. Simon Cancer Center at Morristown Memorial Hospital
-
Neptune, New Jersey, Förenta staterna, 07754-0397
- Jersey Shore Cancer Center at Jersey Shore University Medical Center
-
Summit, New Jersey, Förenta staterna, 07902
- Overlook Hospital
-
-
New York
-
Bronx, New York, Förenta staterna, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
-
Buffalo, New York, Förenta staterna, 14215
- Veterans Affairs Medical Center - Buffalo
-
Clifton Springs, New York, Förenta staterna, 14432
- Finger Lakes Hematology and Oncology
-
Glens Falls, New York, Förenta staterna, 12801
- Adirondack Cancer Care - Glens Falls
-
Manhasset, New York, Förenta staterna, 11030
- CCOP - North Shore University Hospital
-
Manhasset, New York, Förenta staterna, 11030
- Don Monti Comprehensive Cancer Center at North Shore University Hospital
-
Middletown, New York, Förenta staterna, 10940-4199
- Tucker Center for Cancer Care at Orange Regional Medical Center
-
Mineola, New York, Förenta staterna, 11501
- Winthrop University Hospital
-
New Hyde Park, New York, Förenta staterna, 11042
- Long Island Jewish Medical Center
-
Rochester, New York, Förenta staterna, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
-
Rochester, New York, Förenta staterna, 14623
- Interlakes Oncology/Hematology PC
-
Syracuse, New York, Förenta staterna, 13210
- SUNY Upstate Medical University Hospital
-
-
North Carolina
-
Goldsboro, North Carolina, Förenta staterna, 27534
- Wayne Memorial Hospital, Incorporated
-
Kinston, North Carolina, Förenta staterna, 28501
- Lenoir Memorial Cancer Center
-
Rutherfordton, North Carolina, Förenta staterna, 28139
- Rutherford Hospital
-
Wilmington, North Carolina, Förenta staterna, 28401
- Zimmer Cancer Center at New Hanover Regional Medical Center
-
-
North Dakota
-
Bismarck, North Dakota, Förenta staterna, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, Förenta staterna, 58501
- Medcenter One Hospital Cancer Care Center
-
Bismarck, North Dakota, Förenta staterna, 58501
- Mid Dakota Clinic, PC
-
Bismarck, North Dakota, Förenta staterna, 58502
- St. Alexius Medical Center Cancer Center
-
Fargo, North Dakota, Förenta staterna, 58122
- CCOP - MeritCare Hospital
-
Fargo, North Dakota, Förenta staterna, 58122
- MeritCare Broadway
-
Fargo, North Dakota, Förenta staterna, 58103
- Dakota Cancer Institute at Dakota Clinic - South University
-
-
Ohio
-
Akron, Ohio, Förenta staterna, 44307
- McDowell Cancer Center at Akron General Medical Center
-
Bowling Green, Ohio, Förenta staterna, 43402
- Wood County Oncology Center
-
Canton, Ohio, Förenta staterna, 44708
- Mercy Cancer Center at Mercy Medical Center
-
Chillicothe, Ohio, Förenta staterna, 45601
- Adena Regional Medical Center
-
Cincinnati, Ohio, Förenta staterna, 45267
- Charles M. Barrett Cancer Center at University Hospital
-
Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic Taussig Cancer Center
-
Cleveland, Ohio, Förenta staterna, 44109
- MetroHealth's Cancer Care Center at MetroHealth Medical Center
-
Columbus, Ohio, Förenta staterna, 43214-3998
- Riverside Methodist Hospital Cancer Care
-
Columbus, Ohio, Förenta staterna, 43222
- Mount Carmel Health - West Hospital
-
Columbus, Ohio, Förenta staterna, 43215
- CCOP - Columbus
-
Columbus, Ohio, Förenta staterna, 43228
- Doctors Hospital at Ohio Health
-
Columbus, Ohio, Förenta staterna, 43215
- Grant Riverside Cancer Services
-
Dayton, Ohio, Förenta staterna, 45428
- Veterans Affairs Medical Center - Dayton
-
Dayton, Ohio, Förenta staterna, 45405
- Grandview Hospital
-
Dayton, Ohio, Förenta staterna, 45406
- Good Samaritan Hospital
-
Dayton, Ohio, Förenta staterna, 45415
- Samaritan North Cancer Care Center
-
Dayton, Ohio, Förenta staterna, 45429
- CCOP - Dayton
-
Delaware, Ohio, Förenta staterna, 43015
- Grady Memorial Hospital
-
Findlay, Ohio, Förenta staterna, 45840
- Blanchard Valley Medical Associates
-
Fremont, Ohio, Förenta staterna, 43420
- Fremont Memorial Hospital
-
Independence, Ohio, Förenta staterna, 44131
- Community Oncology Group at Cleveland Clinic Cancer Center
-
Kenton, Ohio, Förenta staterna, 43326
- Kenton Oncology, Incorporated
-
Kettering, Ohio, Förenta staterna, 45429
- Charles F. Kettering Memorial Hospital
-
Lancaster, Ohio, Förenta staterna, 43130
- Fairfield Medical Center
-
Lima, Ohio, Förenta staterna, 45804
- Lima Memorial Hospital
-
Lima, Ohio, Förenta staterna, 45801
- St. Rita's Medical Center
-
Mansfield, Ohio, Förenta staterna, 44903
- MedCentral - Mansfield Hospital
-
Marietta, Ohio, Förenta staterna, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
-
Maumee, Ohio, Förenta staterna, 43537
- St. Luke's Hospital
-
Maumee, Ohio, Förenta staterna, 43623
- Northwest Ohio Oncology Center
-
Middletown, Ohio, Förenta staterna, 45044
- Middletown Regional Hospital
-
Newark, Ohio, Förenta staterna, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
-
Oregon, Ohio, Förenta staterna, 43616
- St. Charles Mercy Hospital
-
Oregon, Ohio, Förenta staterna, 43616
- Toledo Clinic - Oregon
-
Sandusky, Ohio, Förenta staterna, 44870
- Firelands Regional Medical Center
-
Sandusky, Ohio, Förenta staterna, 44870
- North Coast Cancer Care, Incorporated
-
Springfield, Ohio, Förenta staterna, 45505
- Community Hospital of Springfield and Clark County
-
Springfield, Ohio, Förenta staterna, 45504
- Mercy Medical Center
-
Sylvania, Ohio, Förenta staterna, 43560
- Flower Hospital Cancer Center
-
Toledo, Ohio, Förenta staterna, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, Förenta staterna, 43606
- Toledo Hospital
-
Toledo, Ohio, Förenta staterna, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, Förenta staterna, 43617
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, Förenta staterna, 43623
- Toledo Clinic, Incorporated - Main Clinic
-
Troy, Ohio, Förenta staterna, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Wauseon, Ohio, Förenta staterna, 43567
- Fulton County Health Center
-
Westerville, Ohio, Förenta staterna, 43081
- Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
-
Wooster, Ohio, Förenta staterna, 44691
- Cleveland Clinic - Wooster
-
Xenia, Ohio, Förenta staterna, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
-
Youngstown, Ohio, Förenta staterna, 44501
- Tod Children's Hospital - Forum Health
-
Zanesville, Ohio, Förenta staterna, 43701
- Genesis - Good Samaritan Hospital
-
-
Oregon
-
Klamath Falls, Oregon, Förenta staterna, 97601
- Merle West Medical Center Cancer Treatment Center
-
Portland, Oregon, Förenta staterna, 97207
- Veterans Affairs Medical Center - Portland
-
Portland, Oregon, Förenta staterna, 97239-3098
- Oregon Health & Science University Cancer Institute
-
Portland, Oregon, Förenta staterna, 97232
- Kaiser Permanente Health Care - Portland
-
Salem, Oregon, Förenta staterna, 97309-5014
- Salem Hospital Regional Cancer Care Services
-
-
Pennsylvania
-
Allentown, Pennsylvania, Förenta staterna, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
-
Danville, Pennsylvania, Förenta staterna, 17822-0001
- Geisinger Medical Center
-
DuBois, Pennsylvania, Förenta staterna, 15801
- Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center
-
Easton, Pennsylvania, Förenta staterna, 18042
- Easton Regional Cancer Center at Easton Hospital
-
Harrisburg, Pennsylvania, Förenta staterna, 17105
- PinnacleHealth Regional Cancer Center at Polyclinic Hospital
-
Lancaster, Pennsylvania, Förenta staterna, 17604
- Lancaster General Hospital
-
Langhorne, Pennsylvania, Förenta staterna, 19047
- St. Mary Regional Cancer Center
-
Pittsburgh, Pennsylvania, Förenta staterna, 15212
- Allegheny Cancer Center at Allegheny General Hospital
-
Scranton, Pennsylvania, Förenta staterna, 18501
- Mercy Hospital Cancer Center - Scranton
-
Scranton, Pennsylvania, Förenta staterna, 18510
- Hematology and Oncology Associates of Northeastern Pennsylvania
-
State College, Pennsylvania, Förenta staterna, 16801
- Geisinger Medical Group - Scenery Park
-
Wilkes-Barre, Pennsylvania, Förenta staterna, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
-
-
South Carolina
-
Anderson, South Carolina, Förenta staterna, 29621
- AnMed Cancer Center
-
Charleston, South Carolina, Förenta staterna, 29425
- Hollings Cancer Center at Medical University of South Carolina
-
Greenville, South Carolina, Förenta staterna, 29615
- CCOP - Greenville
-
Greenville, South Carolina, Förenta staterna, 29601
- Bon Secours St. Francis Health System
-
Spartanburg, South Carolina, Förenta staterna, 29303
- CCOP - Upstate Carolina
-
Spartanburg, South Carolina, Förenta staterna, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
-
-
South Dakota
-
Rapid City, South Dakota, Förenta staterna, 57701
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, Förenta staterna, 57105
- Avera Cancer Institute
-
Sioux Falls, South Dakota, Förenta staterna, 57117-5039
- Sioux Valley Hospital and University of South Dakota Medical Center
-
Sioux Falls, South Dakota, Förenta staterna, 57105
- Medical X-Ray Center, PC
-
-
Tennessee
-
Knoxville, Tennessee, Förenta staterna, 37916
- Thompson Cancer Survival Center
-
Knoxville, Tennessee, Förenta staterna, 37920-6999
- U.T. Cancer Institute at University of Tennessee Medical Center
-
Memphis, Tennessee, Förenta staterna, 38104
- University of Tennessee Cancer Institute - Medical Center
-
-
Texas
-
Dallas, Texas, Förenta staterna, 75230
- Medical City Dallas Hospital
-
Fort Sam Houston, Texas, Förenta staterna, 78234
- Brooke Army Medical Center
-
Houston, Texas, Förenta staterna, 77030
- Ben Taub General Hospital
-
Houston, Texas, Förenta staterna, 77030
- Methodist Hospital
-
Houston, Texas, Förenta staterna, 77030
- Veterans Affairs Medical Center - Houston
-
Houston, Texas, Förenta staterna, 77030
- Baylor University Medical Center - Houston
-
Houston, Texas, Förenta staterna, 77030
- St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
-
Lackland Air Force Base, Texas, Förenta staterna, 78236
- Wilford Hall Medical Center
-
Lubbock, Texas, Förenta staterna, 79415-3364
- UMC Southwest Cancer and Research Center
-
San Antonio, Texas, Förenta staterna, 78229
- Cancer Therapy and Research Center
-
San Antonio, Texas, Förenta staterna, 78209
- Veterans Affairs Medical Center - San Antonio (Murphy)
-
San Antonio, Texas, Förenta staterna, 78229-3900
- University of Texas Health Science Center at San Antonio
-
San Antonio, Texas, Förenta staterna, 78229
- University Hospital - San Antonio
-
Temple, Texas, Förenta staterna, 76508
- CCOP - Scott and White Hospital
-
-
Utah
-
American Fork, Utah, Förenta staterna, 84003
- American Fork Hospital
-
Logan, Utah, Förenta staterna, 84321
- Logan Regional Hospital
-
Murray, Utah, Förenta staterna, 84107
- Cottonwood Hospital Medical Center
-
Ogden, Utah, Förenta staterna, 84403
- McKay-Dee Hospital Center
-
Provo, Utah, Förenta staterna, 84604
- Utah Valley Regional Medical Center - Provo
-
Saint George, Utah, Förenta staterna, 84770
- Dixie Regional Medical Center - East Campus
-
Salt Lake City, Utah, Förenta staterna, 84112
- Huntsman Cancer Institute at University of Utah
-
Salt Lake City, Utah, Förenta staterna, 84106
- Utah Cancer Specialists at UCS Cancer Center
-
Salt Lake City, Utah, Förenta staterna, 84143
- Latter Day Saints Hospital
-
-
Virginia
-
Charlottesville, Virginia, Förenta staterna, 22901
- Martha Jefferson Hospital Cancer Care Center
-
Danville, Virginia, Förenta staterna, 24541
- Danville Regional Medical Center
-
Lynchburg, Virginia, Förenta staterna, 24501
- Lynchburg Hematology-Oncology Clinic
-
Newport News, Virginia, Förenta staterna, 23601
- Peninsula Cancer Institute - Newport News Office
-
Richmond, Virginia, Förenta staterna, 23249
- Veterans Affairs Medical Center - Richmond
-
-
Washington
-
Auburn, Washington, Förenta staterna, 98002
- Auburn Regional Center for Cancer Care
-
Bellingham, Washington, Förenta staterna, 98225
- St. Joseph Cancer Center
-
Bremerton, Washington, Förenta staterna, 98310
- Olympic Hematology and Oncology
-
Centralia, Washington, Förenta staterna, 98531-9027
- Providence Centralia Hospital Regional Cancer Center
-
Federal Way, Washington, Förenta staterna, 98003
- St. Francis Hospital
-
Mount Vernon, Washington, Förenta staterna, 98273
- Skagit Valley Hospital Cancer Care Center
-
Olympia, Washington, Förenta staterna, 98506-5166
- Providence St. Peter Hospital Regional Cancer Center
-
Puyallup, Washington, Förenta staterna, 98372
- Good Samaritan Cancer Center
-
Seattle, Washington, Förenta staterna, 98104
- Harborview Medical Center
-
Seattle, Washington, Förenta staterna, 98104
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, Förenta staterna, 98104
- Minor and James Medical, PLLC
-
Seattle, Washington, Förenta staterna, 98112
- Group Health Central Hospital
-
Seattle, Washington, Förenta staterna, 98122-4307
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
-
Seattle, Washington, Förenta staterna, 98122
- Polyclinic First Hill
-
Seattle, Washington, Förenta staterna, 98195-6043
- University Cancer Center at University of Washington Medical Center
-
Spokane, Washington, Förenta staterna, 99202
- Cancer Care Northwest - Spokane South
-
Spokane, Washington, Förenta staterna, 99204-2967
- Rockwood Clinic Cancer Treatment Center
-
Spokane, Washington, Förenta staterna, 99204
- Providence Cancer Center at Sacred Heart Medical Center
-
Spokane, Washington, Förenta staterna, 99207
- Providence Cancer Center at Holy Family Hospital
-
Tacoma, Washington, Förenta staterna, 98405
- Allenmore Hospital
-
Tacoma, Washington, Förenta staterna, 98405
- CCOP - Northwest
-
Tacoma, Washington, Förenta staterna, 98405
- MultiCare Regional Cancer Center at Tacoma General Hospital
-
Tacoma, Washington, Förenta staterna, 98499
- St. Clare Hospital
-
Tacoma, Washington, Förenta staterna, 98405-3004
- St. Joseph Medical Center at Franciscan Health System
-
Wenatchee, Washington, Förenta staterna, 98801-2028
- Wenatchee Valley Medical Center
-
-
Wisconsin
-
Appleton, Wisconsin, Förenta staterna, 54911-3496
- Fox Valley Hematology and Oncology - East Grant Street
-
Green Bay, Wisconsin, Förenta staterna, 54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, Förenta staterna, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay, Wisconsin, Förenta staterna, 54303
- St. Mary's Hospital Medical Center - Green Bay
-
Green Bay, Wisconsin, Förenta staterna, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital
-
Janesville, Wisconsin, Förenta staterna, 53547
- Mercy Regional Cancer Center
-
La Crosse, Wisconsin, Förenta staterna, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
-
Manitowoc, Wisconsin, Förenta staterna, 54221-1450
- Holy Family Memorial Medical Center Cancer Care Center
-
Marinette, Wisconsin, Förenta staterna, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
-
Marshfield, Wisconsin, Förenta staterna, 54449
- Marshfield Clinic - Marshfield Center
-
Oconto Falls, Wisconsin, Förenta staterna, 54154
- Green Bay Oncology, Limited - Oconto Falls
-
Racine, Wisconsin, Förenta staterna, 53405
- All Saints Cancer Center at Wheaton Franciscan Healthcare
-
Rice Lake, Wisconsin, Förenta staterna, 54868
- Marshfield Clinic - Indianhead Center
-
Sturgeon Bay, Wisconsin, Förenta staterna, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
-
Wausau, Wisconsin, Förenta staterna, 54401
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
-
-
Wyoming
-
Sheridan, Wyoming, Förenta staterna, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
-
-
-
-
Saskatchewan
-
Regina, Saskatchewan, Kanada, S4T 7T1
- Allan Blair Cancer Centre at Pasqua Hospital
-
Saskatoon, Saskatchewan, Kanada, S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 120 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed extensive stage small cell lung cancer (SCLC)
- Measurable or evaluable disease by CT scan, MRI, x-ray, physical exam, or nuclear exam
- Brain metastases allowed if previously treated with radiotherapy and/or surgery and are neurologically stable (i.e., no progressing symptoms and off steroids and anticonvulsants)
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,000/mm^3
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST or ALT no greater than 2.5 times ULN
Renal
- Creatinine normal
- Creatinine clearance at least 50 mL/min
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- HIV negative
- No concurrent AIDS-related illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior biologic therapy for SCLC
- No filgrastim (G-CSF) within 24 hours of chemotherapy
Chemotherapy
- No prior systemic chemotherapy for SCLC
Endocrine therapy
- See Disease Characteristics
Radiotherapy
- See Disease Characteristics
- At least 21 days since prior brain radiotherapy and recovered
- No other prior radiotherapy for SCLC
Surgery
- See Disease Characteristics
- At least 21 days since prior thoracic or other major surgery and recovered
Other
- No concurrent enzyme inducing antiepileptic drugs (phenytoin, phenobarbital, oxcarboxepine, or carbamazepine)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 2
|
Arm 1: 60 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles Arm 2: 80 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles
100 mg/m2 IV (over 30-60 min) on Days 1 , 2 & 3. Q 3 weeks x 4 Cycles
|
|
Aktiv komparator: 1
|
Arm 1: 60 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles Arm 2: 80 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles
60 mg/m2 IV (over 90 min)on Days 1, 8 & 15.
Q 4 weeks x 4 Cycles
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Survival
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Progression-free Survival
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Primo N. Lara, MD, University of California, Davis
- Huvudutredare: Ronald B. Natale, MD, Cedars-Sinai Medical Center
- Huvudutredare: David R. Gandara, MD, University of California, Davis
- Huvudutredare: James R. Jett, MD, Mayo Clinic
- Huvudutredare: Jane Carleton, MD, Don Monti Comprehensive Cancer Center at North Shore University Hospital
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Lara PN Jr, Chansky K, Shibata T, Fukuda H, Tamura T, Crowley J, Redman MW, Natale R, Saijo N, Gandara DR. Common arm comparative outcomes analysis of phase 3 trials of cisplatin + irinotecan versus cisplatin + etoposide in extensive stage small cell lung cancer: final patient-level results from Japan Clinical Oncology Group 9511 and Southwest Oncology Group 0124. Cancer. 2010 Dec 15;116(24):5710-5. doi: 10.1002/cncr.25532. Epub 2010 Aug 24.
- Lara PN Jr, Natale R, Crowley J, Lenz HJ, Redman MW, Carleton JE, Jett J, Langer CJ, Kuebler JP, Dakhil SR, Chansky K, Gandara DR. Phase III trial of irinotecan/cisplatin compared with etoposide/cisplatin in extensive-stage small-cell lung cancer: clinical and pharmacogenomic results from SWOG S0124. J Clin Oncol. 2009 May 20;27(15):2530-5. doi: 10.1200/JCO.2008.20.1061. Epub 2009 Apr 6.
- Natale RB, Lara PN, Chansky K, et al.: S0124: A randomized phase III trial comparing irinotecan/cisplatin (IP) with etoposide/cisplatin (EP) in patients (pts) with previously untreated extensive stage small cell lung cancer (E-SCLC). [Abstract] J Clin Oncol 26 (Suppl 15): A-7512, 2008.
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2002
Primärt slutförande (Faktisk)
1 mars 2008
Avslutad studie (Faktisk)
1 december 2009
Studieregistreringsdatum
Först inskickad
6 september 2002
Först inskickad som uppfyllde QC-kriterierna
26 januari 2003
Första postat (Uppskatta)
27 januari 2003
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
31 juli 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 juli 2018
Senast verifierad
1 juli 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Luftvägssjukdomar
- Neoplasmer
- Lungsjukdomar
- Neoplasmer efter plats
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Karcinom, bronkogent
- Bronkiella neoplasmer
- Lungneoplasmer
- Småcelligt lungkarcinom
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antineoplastiska medel
- Antineoplastiska medel, fytogena
- Topoisomeras II-hämmare
- Topoisomerasinhibitorer
- Topoisomeras I-hämmare
- Etoposid
- Irinotekan
Andra studie-ID-nummer
- CDR0000256908
- U10CA032102 (U.S.S. NIH-anslag/kontrakt)
- S0124 (Annan identifierare: CALGB)
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