- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00004859
Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Patients With Stage III Non-small Cell Lung Cancer
A Randomized Phase III Trial of Carboplatin, Paclitaxel and Thoracic Radiotherapy, With or Without Thalidomide, in Patients With Stage III Non-Small Cell Lung Cancer (NSCLC)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
OBJECTIVES:
I. Compare the survival and time to progression of patients with stage IIIA or IIIB non-small cell lung cancer when treated with carboplatin, paclitaxel, and chemoradiotherapy with or without thalidomide.
II. Evaluate the toxicity of the thalidomide-containing regimen and compare response rates of the two groups.
III. Determine whether the inactivation of p16, Death-associated protein kinase (DAP-kinase), O6-methylguanine-DNA methyltransferase (MGMT) gene, or tissue-inhibitor of metalloproteinase 3 (TIMP-3) genes can be used to predict survival in these patients treated with this regimen.
IV. Determine whether the detection of a methylation biomarker in serum can be used to predict survival in these patients treated with this regimen.
OUTLINE: This is a randomized study. Patients are stratified according to disease histology (squamous vs nonsquamous), performance status (0 vs 1), disease stage (IIIA vs IIIB), and time of randomization (before addition of chemoradiotherapy vs after). Patients are randomized to one of two treatment arms.
ARM A: Patients receive paclitaxel intravenously (IV) over 3 hours immediately followed by carboplatin IV over 15-30 minutes on days 1 and 22. Treatment continues every 22 days in the absence of unacceptable toxicity or disease progression.
ARM B: Patients receive paclitaxel and carboplatin as in arm A. Patients also receive oral thalidomide and oral low-dose aspirin daily beginning on day 1 for up to 24 months in the absence of disease progression.
Beginning between days 43-50, patients in both arms with stable or responding disease receive chemoradiotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 15-30 minutes once weekly for 6 weeks and radiotherapy (RT) 5 days a week for 6 weeks. Arm B patients continue oral thalidomide.
Patients are followed every 2 months for 2 years and then every 6 months for 3 years.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
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Pretoria, Südafrika, 0001
- Pretoria Academic Hospital
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Arkansas
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Ft. Smith, Arkansas, Vereinigte Staaten, 72903
- Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
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California
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Modesto, California, Vereinigte Staaten, 95355
- Memorial Medical Center Cancer Services
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Salinas, California, Vereinigte Staaten, 93901
- Salinas Valley Memorial Hospital
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Stanford, California, Vereinigte Staaten, 94305
- Stanford Comprehensive Cancer Center at Stanford University Medical Center
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Colorado
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Aurora, Colorado, Vereinigte Staaten, 80012
- Aurora Presbyterian Hospital
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Boulder, Colorado, Vereinigte Staaten, 80301-9019
- Boulder Community Hospital
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Colorado Springs, Colorado, Vereinigte Staaten, 80933
- Penrose Cancer Center at Penrose Hospital
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Colorado Springs, Colorado, Vereinigte Staaten, 80909
- Memorial Hospital
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Denver, Colorado, Vereinigte Staaten, 80210
- Porter Adventist Hospital
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Denver, Colorado, Vereinigte Staaten, 80220
- Rose Medical Center
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Denver, Colorado, Vereinigte Staaten, 80218
- Presbyterian - St. Luke's Medical Center
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Denver, Colorado, Vereinigte Staaten, 80218
- St. Joseph Hospital
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Denver, Colorado, Vereinigte Staaten, 80224-2522
- CCOP - Colorado Cancer Research Program, Incorporated
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Englewood, Colorado, Vereinigte Staaten, 80110
- Swedish Medical Center
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Grand Junction, Colorado, Vereinigte Staaten, 81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
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Lone Tree, Colorado, Vereinigte Staaten, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Vereinigte Staaten, 80502
- Hope Cancer Care Center at Longmont United Hospital
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Pueblo, Colorado, Vereinigte Staaten, 81004
- St. Mary-Corwin Regional Medical Center
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Thornton, Colorado, Vereinigte Staaten, 80229
- North Suburban Medical Center
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Connecticut
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Danbury, Connecticut, Vereinigte Staaten, 06810
- Praxair Cancer Center at Danbury Hospital
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Norwich, Connecticut, Vereinigte Staaten, 06360
- William W. Backus Hospital
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Florida
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Daytona Beach, Florida, Vereinigte Staaten, 32115
- Halifax Medical Center - Daytona Beach
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Jacksonville, Florida, Vereinigte Staaten, 32207
- Baptist Cancer Institute - Jacksonville
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Georgia
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Augusta, Georgia, Vereinigte Staaten, 30912
- MBCCOP - Medical College of Georgia Cancer Center
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Augusta, Georgia, Vereinigte Staaten, 30904
- Veterans Affairs Medical Center - Augusta
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Decatur, Georgia, Vereinigte Staaten, 30033
- Veterans Affairs Medical Center - Atlanta (Decatur)
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Macon, Georgia, Vereinigte Staaten, 31208
- Medical Center of Central Georgia
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Savannah, Georgia, Vereinigte Staaten, 31403-3089
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Valdosta, Georgia, Vereinigte Staaten, 31603
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Chicago, Illinois, Vereinigte Staaten, 60625
- Swedish Covenant Hospital
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Chicago, Illinois, Vereinigte Staaten, 60616
- Mercy Hospital and Medical Center
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Hinsdale, Illinois, Vereinigte Staaten, 60521
- Hinsdale Hematology Oncology Associates
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Joliet, Illinois, Vereinigte Staaten, 60432
- Midwest Center for Hematology/Oncology
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Moline, Illinois, Vereinigte Staaten, 61265
- Trinity Medical Center - East
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Rockford, Illinois, Vereinigte Staaten, 61104-2315
- Swedish-American Regional Cancer Center
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Skokie, Illinois, Vereinigte Staaten, 60076
- Hematology/Oncology of the North Shore at Gross Point Medical Center
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Indiana
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Elkhart, Indiana, Vereinigte Staaten, 46515
- Elkhart General Hospital
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Kokomo, Indiana, Vereinigte Staaten, 46904
- Howard Community Hospital at Howard Regional Health System
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La Porte, Indiana, Vereinigte Staaten, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Richmond, Indiana, Vereinigte Staaten, 47374
- Reid Hospital & Health Care Services, Incorporated
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South Bend, Indiana, Vereinigte Staaten, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Vereinigte Staaten, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, Vereinigte Staaten, 46617
- Saint Joseph Regional Medical Center
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Iowa
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Bettendorf, Iowa, Vereinigte Staaten, 52722
- Hematology Oncology Associates of the Quad Cities
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Cedar Rapids, Iowa, Vereinigte Staaten, 52402
- St. Luke's Hospital
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Cedar Rapids, Iowa, Vereinigte Staaten, 52403
- Cedar Rapids Oncology Associates
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Cedar Rapids, Iowa, Vereinigte Staaten, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Davenport, Iowa, Vereinigte Staaten, 52803
- Genesis Regional Cancer Center at Genesis Medical Center
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Des Moines, Iowa, Vereinigte Staaten, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Vereinigte Staaten, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Vereinigte Staaten, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Vereinigte Staaten, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Vereinigte Staaten, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Vereinigte Staaten, 50307
- Mercy Capitol Hospital
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Des Moines, Iowa, Vereinigte Staaten, 50316-2301
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Sioux City, Iowa, Vereinigte Staaten, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Vereinigte Staaten, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, Vereinigte Staaten, 51104
- Mercy Medical Center - Sioux City
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West Des Moines, Iowa, Vereinigte Staaten, 50266
- Medical Oncology and Hematology Associates - West Des Moines
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Kentucky
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Madisonville, Kentucky, Vereinigte Staaten, 42431
- Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
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Maryland
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Annapolis, Maryland, Vereinigte Staaten, 21401
- DeCesaris Cancer Institute at Anne Arundel Medical Center
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02111
- Tufts-NEMC Cancer Center
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Newton, Massachusetts, Vereinigte Staaten, 02462
- Newton-Wellesley Hospital
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Springfield, Massachusetts, Vereinigte Staaten, 01199
- Baystate Regional Cancer Program at D'Amour Center for Cancer Care
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Taunton, Massachusetts, Vereinigte Staaten, 02780
- Morton Hospital & Medical Center
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Michigan
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Adrian, Michigan, Vereinigte Staaten, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, Vereinigte Staaten, 48106
- CCOP - Michigan Cancer Research Consortium
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Ann Arbor, Michigan, Vereinigte Staaten, 48106-0995
- St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
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Dearborn, Michigan, Vereinigte Staaten, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Escanaba, Michigan, Vereinigte Staaten, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, Vereinigte Staaten, 48503
- Hurley Medical Center
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Flint, Michigan, Vereinigte Staaten, 48503
- Genesys Hurley Cancer Institute
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Grosse Pointe Woods, Michigan, Vereinigte Staaten, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Iron Mountain, Michigan, Vereinigte Staaten, 49801
- Green Bay Oncology, Limited - Iron Mountain
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Jackson, Michigan, Vereinigte Staaten, 49201
- Foote Hospital
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Kalamazoo, Michigan, Vereinigte Staaten, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Vereinigte Staaten, 49007-3731
- West Michigan Cancer Center
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Kalamazooaa, Michigan, Vereinigte Staaten, 49001
- Borgess Medical Center
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Lambertville, Michigan, Vereinigte Staaten, 48144
- Haematology-Oncology Associates of Ohio and Michigan, PC
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Lansing, Michigan, Vereinigte Staaten, 48909
- Sparrow Regional Cancer Center
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Monroe, Michigan, Vereinigte Staaten, 48162
- Mercy Memorial Hospital System
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Saginaw, Michigan, Vereinigte Staaten, 48601
- Seton Cancer Institute - Saginaw
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St. Joseph, Michigan, Vereinigte Staaten, 49085
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
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Warren, Michigan, Vereinigte Staaten, 48093
- St. John Macomb Hospital
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Minnesota
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Burnsville, Minnesota, Vereinigte Staaten, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Vereinigte Staaten, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Vereinigte Staaten, 55805
- CCOP - Duluth
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Duluth, Minnesota, Vereinigte Staaten, 55805
- St. Mary's - Duluth Clinic Cancer Center
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Duluth, Minnesota, Vereinigte Staaten, 55805
- Miller-Dwan Medical Center
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Edina, Minnesota, Vereinigte Staaten, 55435
- Fairview Southdale Hospital
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Fergus Falls, Minnesota, Vereinigte Staaten, 56537
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Fridley, Minnesota, Vereinigte Staaten, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Vereinigte Staaten, 55350
- Hutchinson Area Health Care
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Lichfield, Minnesota, Vereinigte Staaten, 55355
- Meeker County Memorial Hospital
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Maplewood, Minnesota, Vereinigte Staaten, 55109
- HealthEast Cancer Care at St. John's Hospital
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Minneapolis, Minnesota, Vereinigte Staaten, 55415
- Hennepin County Medical Center - Minneapolis
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Minneapolis, Minnesota, Vereinigte Staaten, 55407
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
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Robbinsdale, Minnesota, Vereinigte Staaten, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
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Saint Louis Park, Minnesota, Vereinigte Staaten, 55416
- CCOP - Metro-Minnesota
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Shakopee, Minnesota, Vereinigte Staaten, 55379
- Saint Francis Cancer Center
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St Paul, Minnesota, Vereinigte Staaten, 55102
- St. Joseph's Hospital
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St. Cloud, Minnesota, Vereinigte Staaten, 56303
- CentraCare Clinic - River Campus
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St. Louis Park, Minnesota, Vereinigte Staaten, 55416
- Park Nicollet Health Services
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St. Paul, Minnesota, Vereinigte Staaten, 55102
- United Hospital
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St. Paul, Minnesota, Vereinigte Staaten, 55101
- Regions Hospital Cancer Care Center
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Waconia, Minnesota, Vereinigte Staaten, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, Vereinigte Staaten, 55125
- Woodwinds Health Campus
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Missouri
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Kansas City, Missouri, Vereinigte Staaten, 64131
- CCOP - Kansas City
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Springfield, Missouri, Vereinigte Staaten, 65804
- St. John's Regional Health Center
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Springfield, Missouri, Vereinigte Staaten, 65807
- Hulston Cancer Center at Cox Medical Center South
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St. Louis, Missouri, Vereinigte Staaten, 63131
- Missouri Baptist Cancer Center
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Montana
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Billings, Montana, Vereinigte Staaten, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, Vereinigte Staaten, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, Vereinigte Staaten, 59107-7000
- Deaconess Billings Clinic - Downtown
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Great Falls, Montana, Vereinigte Staaten, 59405
- Great Falls Clinic
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Great Falls, Montana, Vereinigte Staaten, 59405
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Great Falls, Montana, Vereinigte Staaten, 59405
- Big Sky Oncology
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Great Falls, Montana, Vereinigte Staaten, 59405
- Sletten Regional Cancer Institute at Benefis Healthcare
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Nebraska
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Lincoln, Nebraska, Vereinigte Staaten, 68510
- Cancer Resource Center - Lincoln
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Omaha, Nebraska, Vereinigte Staaten, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Vereinigte Staaten, 68122
- Immanuel Medical Center
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Omaha, Nebraska, Vereinigte Staaten, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
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Omaha, Nebraska, Vereinigte Staaten, 68131-2197
- Creighton University Medical Center
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Nevada
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Las Vegas, Nevada, Vereinigte Staaten, 89106
- CCOP - Nevada Cancer Research Foundation
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New Jersey
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East Orange, New Jersey, Vereinigte Staaten, 07018-1095
- Veterans Affairs Medical Center - East Orange
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Flemington, New Jersey, Vereinigte Staaten, 08822
- Hunterdon Regional Cancer Center at Hunterdon Medical Center
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Hamilton, New Jersey, Vereinigte Staaten, 08690
- Cancer Institute of New Jersey at Hamilton
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Marlton, New Jersey, Vereinigte Staaten, 08053
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
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Montclair, New Jersey, Vereinigte Staaten, 07042
- Mountainside Hospital Cancer Center
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Morristown, New Jersey, Vereinigte Staaten, 07962
- Carol G. Simon Cancer Center at Morristown Memorial Hospital
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New Brunswick, New Jersey, Vereinigte Staaten, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Phillipsburg, New Jersey, Vereinigte Staaten, 08865
- Warren Hospital
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Red Bank, New Jersey, Vereinigte Staaten, 07701
- Booker Cancer Center at Riverview Medical Center
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Somers Point, New Jersey, Vereinigte Staaten, 08244
- Shore Memorial Hospital - Somers Point
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Summit, New Jersey, Vereinigte Staaten, 07902
- Overlook Hospital
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Voorhees, New Jersey, Vereinigte Staaten, 08043
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
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New York
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Bronx, New York, Vereinigte Staaten, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Bronx, New York, Vereinigte Staaten, 10466
- Our Lady of Mercy Medical Center Comprehensive Cancer Center
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Buffalo, New York, Vereinigte Staaten, 14215
- Veterans Affairs Medical Center - Buffalo
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Rochester, New York, Vereinigte Staaten, 14621
- Lipson Cancer and Blood Center at Rochester General Hospital
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Syracuse, New York, Vereinigte Staaten, 13057
- CCOP - Hematology-Oncology Associates of Central New York
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North Carolina
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Goldsboro, North Carolina, Vereinigte Staaten, 27534
- Wayne Memorial Hospital, Incorporated
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Wilson, North Carolina, Vereinigte Staaten, 27893-3428
- Wilson Medical Center
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North Dakota
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Bismarck, North Dakota, Vereinigte Staaten, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, Vereinigte Staaten, 58501
- Cancer Care Center at Medcenter One Hospital
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Bismarck, North Dakota, Vereinigte Staaten, 58501
- Mid Dakota Clinic, P. C.
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Bismarck, North Dakota, Vereinigte Staaten, 58502
- St. Alexius Medical Center
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Ohio
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Akron, Ohio, Vereinigte Staaten, 44309-2090
- Akron City Hospital
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Canton, Ohio, Vereinigte Staaten, 44710-1799
- Aultman Hospital Cancer Center at Aultman Health Foundation
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Chillicothe, Ohio, Vereinigte Staaten, 45601
- Adena Regional Medical Center
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Cleveland, Ohio, Vereinigte Staaten, 44109
- MetroHealth's Cancer Care Center at MetroHealth Medical Center
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Columbus, Ohio, Vereinigte Staaten, 43214-3998
- Riverside Methodist Hospital Cancer Care
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Columbus, Ohio, Vereinigte Staaten, 43222
- Mount Carmel Health - West Hospital
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Columbus, Ohio, Vereinigte Staaten, 43215
- CCOP - Columbus
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Columbus, Ohio, Vereinigte Staaten, 43228
- Doctors Hospital at Ohio Health
-
Columbus, Ohio, Vereinigte Staaten, 43215
- Grant Riverside Cancer Services
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Dayton, Ohio, Vereinigte Staaten, 45428
- Veterans Affairs Medical Center - Dayton
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Dayton, Ohio, Vereinigte Staaten, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
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Dayton, Ohio, Vereinigte Staaten, 45415
- Samaritan North Cancer Care Center
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Delaware, Ohio, Vereinigte Staaten, 43015
- Grady Memorial Hospital
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Findlay, Ohio, Vereinigte Staaten, 45840
- Blanchard Valley Medical Associates
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Fremont, Ohio, Vereinigte Staaten, 43420
- Fremont Memorial Hospital
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Kettering, Ohio, Vereinigte Staaten, 45429
- Charles F. Kettering Memorial Hospital
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Lancaster, Ohio, Vereinigte Staaten, 43130
- Fairfield Medical Center
-
Lima, Ohio, Vereinigte Staaten, 45804
- Lima Memorial Hospital
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Lima, Ohio, Vereinigte Staaten, 45801
- St. Rita's Medical Center
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Mansfield, Ohio, Vereinigte Staaten, 44903
- MedCentral - Mansfield Hospital
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Marietta, Ohio, Vereinigte Staaten, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
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Maumee, Ohio, Vereinigte Staaten, 43537
- St. Luke's Hospital
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Maumee, Ohio, Vereinigte Staaten, 43623
- Northwest Ohio Oncology Center
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Newark, Ohio, Vereinigte Staaten, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
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Oregon, Ohio, Vereinigte Staaten, 43616
- St. Charles Mercy Hospital
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Sandusky, Ohio, Vereinigte Staaten, 44870
- Firelands Regional Medical Center
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Springfield, Ohio, Vereinigte Staaten, 45505
- Community Hospital of Springfield and Clark County
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Springfield, Ohio, Vereinigte Staaten, 45504
- Mercy Medical Center
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Sylvania, Ohio, Vereinigte Staaten, 43560
- Flower Hospital Cancer Center
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Tiffin, Ohio, Vereinigte Staaten, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, Vereinigte Staaten, 43608
- St. Vincent Mercy Medical Center
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Toledo, Ohio, Vereinigte Staaten, 43606
- Toledo Hospital
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Toledo, Ohio, Vereinigte Staaten, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, Vereinigte Staaten, 43623
- Toledo Clinic, Incorporated - Main Clinic
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Toledo, Ohio, Vereinigte Staaten, 43623
- CCOP - Toledo Community Hospital
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Troy, Ohio, Vereinigte Staaten, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
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Wauseon, Ohio, Vereinigte Staaten, 43567
- Fulton County Health Center
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Pennsylvania
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Allentown, Pennsylvania, Vereinigte Staaten, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
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Bryn Mawr, Pennsylvania, Vereinigte Staaten, 19010
- Bryn Mawr Hospital
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Danville, Pennsylvania, Vereinigte Staaten, 17822-0001
- Geisinger Medical Center
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Dubois, Pennsylvania, Vereinigte Staaten, 15801
- Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center
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Easton, Pennsylvania, Vereinigte Staaten, 18042
- Easton Regional Cancer Center at Easton Hospital
-
Harrisburg, Pennsylvania, Vereinigte Staaten, 17105
- PinnacleHealth Regional Cancer Center at Polyclinic Hospital
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Hershey, Pennsylvania, Vereinigte Staaten, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Lancaster, Pennsylvania, Vereinigte Staaten, 17604
- Lancaster General Hospital
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Lewistown, Pennsylvania, Vereinigte Staaten, 17044
- Lewistown Hospital
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Paoli, Pennsylvania, Vereinigte Staaten, 19301-1792
- Paoli Memorial Hospital
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19107
- Joan Karnell Cancer Center at Pennsylvania Hospital
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Phoenixville, Pennsylvania, Vereinigte Staaten, 19460
- Cancer Center at Phoenixville Hospital
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Pittsburgh, Pennsylvania, Vereinigte Staaten, 15212
- Allegheny Cancer Center at Allegheny General Hospital
-
Pittsburgh, Pennsylvania, Vereinigte Staaten, 15232
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
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Pottstown, Pennsylvania, Vereinigte Staaten, 19464
- Pottstown Memorial Regional Cancer Center
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Reading, Pennsylvania, Vereinigte Staaten, 19612-6052
- Reading Hospital and Medical Center
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Scranton, Pennsylvania, Vereinigte Staaten, 18501
- Mercy Hospital Cancer Center - Scranton
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Scranton, Pennsylvania, Vereinigte Staaten, 18510
- Hematology and Oncology Associates
-
Sellersville, Pennsylvania, Vereinigte Staaten, 18960
- Grand View Hospital
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State College, Pennsylvania, Vereinigte Staaten, 16803
- Mount Nittany Medical Center
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West Grove, Pennsylvania, Vereinigte Staaten, 19390-9499
- Jennersville Regional Hospital
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Wilkes-Barre, Pennsylvania, Vereinigte Staaten, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
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Wynnewood, Pennsylvania, Vereinigte Staaten, 19096
- CCOP - MainLine Health
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Wynnewood, Pennsylvania, Vereinigte Staaten, 19096
- Lankenau Cancer Center at Lankenau Hospital
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South Carolina
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Aiken, South Carolina, Vereinigte Staaten, 29801
- Cancer Care Institute of Carolina at Aiken Regional Medical Centers
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Greenville, South Carolina, Vereinigte Staaten, 29615
- CCOP - Greenville
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South Dakota
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Sioux Falls, South Dakota, Vereinigte Staaten, 57105
- Avera Cancer Institute
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Sioux Falls, South Dakota, Vereinigte Staaten, 57117-5039
- Sioux Valley Hospital and University of South Dakota Medical Center
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Sioux Falls, South Dakota, Vereinigte Staaten, 57105
- Medical X-Ray Center, PC
-
-
Tennessee
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Kingsport, Tennessee, Vereinigte Staaten, 37662
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
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Nashville, Tennessee, Vereinigte Staaten, 37208-3599
- MBCCOP - Meharry Medical College - Nashville
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Texas
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Temple, Texas, Vereinigte Staaten, 76508
- CCOP - Scott and White Hospital
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Virginia
-
Charlottesville, Virginia, Vereinigte Staaten, 22908
- University of Virginia Cancer Center at UV Health System
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Danville, Virginia, Vereinigte Staaten, 24541
- Danville Regional Medical Center
-
Norton, Virginia, Vereinigte Staaten, 24273
- Southwest Virginia Regional Cancer Center
-
Richmond, Virginia, Vereinigte Staaten, 23298-0037
- Virginia Commonwealth University Massey Cancer Center
-
-
West Virginia
-
Charleston, West Virginia, Vereinigte Staaten, 25304
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
-
Huntington, West Virginia, Vereinigte Staaten, 25701
- Marshall University Medical Center
-
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Wisconsin
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Green Bay, Wisconsin, Vereinigte Staaten, 54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, Vereinigte Staaten, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay, Wisconsin, Vereinigte Staaten, 54303
- St. Mary's Hospital Medical Center - Green Bay
-
Green Bay, Wisconsin, Vereinigte Staaten, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital
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La Crosse, Wisconsin, Vereinigte Staaten, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
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Madison, Wisconsin, Vereinigte Staaten, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
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Madison, Wisconsin, Vereinigte Staaten, 53717
- Dean Medical Center - Madison
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Marinette, Wisconsin, Vereinigte Staaten, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
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Marshfield, Wisconsin, Vereinigte Staaten, 54449
- Marshfield Clinic - Marshfield Center
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Oconto Falls, Wisconsin, Vereinigte Staaten, 54154
- Green Bay Oncology, Limited - Oconto Falls
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Racine, Wisconsin, Vereinigte Staaten, 53405
- All Saints Cancer Center at All Saints Healthcare
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Sturgeon Bay, Wisconsin, Vereinigte Staaten, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
Histologically confirmed newly diagnosed non-small cell bronchogenic carcinoma
- Squamous cell
- Adenocarcinoma
- Large cell undifferentiated
- Bronchoalveolar
- Non-small cell carcinoma not otherwise stated
Unresectable stage IIIA
- Mediastinal lymph node enlargement of at least 1 cm but less than 2 cm on computed tomography (CT) scans must have mediastinotomy or thoracoscopy to rule out resectability
OR
Stage IIIB disease without significant pleural effusion
- Seen on CT scan only (not seen on chest x-ray) or does not reaccumulate after 1 thoracentesis and is cytologically negative
- Metastases to contralateral, mediastinal, or supraclavicular nodes allowed
- Bidimensionally measurable or evaluable disease
- 18 and over
- ECOG performance status 0-1
Adequate hematopoietic, hepatic, and renal function obtained <=4 weeks prior to registration:
- Platelet count at least 100,000/mm^3
- White Blood Cell (WBC) count at least 4,000/mm^3 OR absolute neutrophil count at least 2,000/mm^3
- Bilirubin normal
- Serum glutamic oxaloacetic transaminase (SGOT) no greater than 2.5 times upper limit of normal
- Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min
- Fertile patients must use 2 methods of effective contraception for 4 weeks prior to, during, and for 4 weeks after study therapy
- Concurrent filgrastim (G-CSF) allowed for persistent neutropenia
Exclusion Criteria:
- Positive pregnancy test,pregnant or nursing
- Uncontrolled high blood pressure, unstable angina, congestive heart failure, or myocardial infarction within the prior year
- Serious cardiac arrhythmias requiring medication
- Prior radiotherapy to only area of measurable or active tumor
- Less than 5 years since prior chemotherapy
- Other active malignancies
- Serious uncontrolled active infection
- Evidence of greater than grade 1 neuropathy by history or physical examination
- History of seizure disorders
- Contraindication to daily low-dose (81 mg/day) aspirin
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Aktiver Komparator: Arm A (Paclitaxel + Carboplatin + RT)
Induction chemotherapy dosing: Paclitaxel, 225 mg/m² (3 hour infusion) Day 1. Carboplatin, area under the plasma drug concentration versus time curve (AUC) =6.0, 15-30 min IV infusion immediately following paclitaxel, Day 1 Concurrent chemotherapy / radiotherapy dosing: Paclitaxel, 45 mg/m2, administered weekly during radiotherapy over one hour. Carboplatin, AUC=2, 15- 30 minutes IV infusion immediately following paclitaxel; administered weekly during radiotherapy Radiation therapy started between days 43-50 from day 1 of cycle 1. The primary tumor and areas of known nodal disease received 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks to the post chemotherapy tumor volume as seen on computed tomography (CT). The initial 50 Gy was delivered to target volume (TV). The final 10 Gy was delivered to a reduced volume targeting defined by TV |
Induction Chemotherapy dosing: AUC=6.0,
15-30 min IV infusion immediately following paclitaxel, Day 1 and Day 22. Concurrent Chemotherapy / Radiotherapy dosing, AUC=2; 15- 30 minutes IV infusion immediately following paclitaxel; administered weekly during radiotherapy
Andere Namen:
Induction chemotherapy dosing: 225 mg/m² (3 hour infusion) Day 1 and Day 22. Concurrent Chemotherapy / Radiotherapy dosing: 45 mg/m2; administered weekly during radiotherapy over one hour
Andere Namen:
Radiation therapy started between days 43-50 from day 1 of cycle 1.
The primary tumor and areas of known nodal disease received 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks to the post chemotherapy tumor volume as seen on computed tomography (CT).
The initial 50 Gy was delivered to target volume (TV).
The final 10 Gy was delivered to a reduced volume targeting defined by TV
Andere Namen:
|
Experimental: Arm B (Paclitaxel + Carboplatin + RT+ Thalidomide)
paclitaxel, carboplatin, and radiotherapy are same as those in Arm A. thalidomide: Induction chemotherapy dosing, oral daily, starting Day 1 for 24 months or until disease progression. Concurrent chemotherapy / radiotherapy dosing, oral daily, begin with 200 mg thalidomide as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg. |
Induction Chemotherapy dosing: AUC=6.0,
15-30 min IV infusion immediately following paclitaxel, Day 1 and Day 22. Concurrent Chemotherapy / Radiotherapy dosing, AUC=2; 15- 30 minutes IV infusion immediately following paclitaxel; administered weekly during radiotherapy
Andere Namen:
Induction chemotherapy dosing: 225 mg/m² (3 hour infusion) Day 1 and Day 22. Concurrent Chemotherapy / Radiotherapy dosing: 45 mg/m2; administered weekly during radiotherapy over one hour
Andere Namen:
Radiation therapy started between days 43-50 from day 1 of cycle 1.
The primary tumor and areas of known nodal disease received 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks to the post chemotherapy tumor volume as seen on computed tomography (CT).
The initial 50 Gy was delivered to target volume (TV).
The final 10 Gy was delivered to a reduced volume targeting defined by TV
Andere Namen:
Induction Chemotherapy dosing: oral daily, starting Day 1 for 24 months or until disease progression.
Concurrent Chemotherapy / Radiotherapy dosing: oral daily, begin with 200 mg thalidomide as a single dose at bedtime.
The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Overall Survival Time
Zeitfenster: every other month until 24 months from study entry, then every 3 months for year 3, every 4 months for year 4 and every 6 months for year 5
|
Survival time is defined as time from study entry to death from any cause
|
every other month until 24 months from study entry, then every 3 months for year 3, every 4 months for year 4 and every 6 months for year 5
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Time to Disease Progression
Zeitfenster: every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year
|
Time to disease progression is defined as the time from randomization to documented disease progression or to death without progression.
Patients without documented progression or death reported were censored at the time of the last documented disease evaluation.
Progression is defined, using the Response Evaluation Criteria In Solid Tumors (RECIST), as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.
|
every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year
|
Response Rate at Best Response to Treatment
Zeitfenster: every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year
|
Proportion of patients with complete or partial response using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.0.
Complete response is defined as the complete disappearance of all clinically detectable malignant disease for at least 4 weeks.
Partial response is defined as greater than or equal to 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease.
|
every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Joan H. Schiller, MD, Simmons Cancer Center
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Belinsky SA, Grimes MJ, Casas E, Stidley CA, Franklin WA, Bocklage TJ, Johnson DH, Schiller JH. Predicting gene promoter methylation in non-small-cell lung cancer by evaluating sputum and serum. Br J Cancer. 2007 Apr 23;96(8):1278-83. doi: 10.1038/sj.bjc.6603721. Epub 2007 Apr 3.
- Belinsky SA, Grimes M, Johnson D, et al.: Predicting gene promoter methylation in lung tumors through examination of sputum and serum. [Abstract] J Clin Oncol 24 (Suppl 18): A-7208, 416s, 2006.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen der Atemwege
- Neubildungen
- Lungenkrankheit
- Neubildungen nach Standort
- Neubildungen der Atemwege
- Thoraxneoplasmen
- Karzinom, bronchogen
- Bronchiale Neubildungen
- Lungentumoren
- Karzinom, nicht-kleinzellige Lunge
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antiinfektiva
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Tubulin-Modulatoren
- Antimitotische Mittel
- Mitose-Modulatoren
- Antineoplastische Mittel, Phytogen
- Angiogenese-Inhibitoren
- Angiogenese-modulierende Mittel
- Wuchsstoffe
- Wachstumshemmer
- Antibakterielle Mittel
- Leprostatische Mittel
- Carboplatin
- Paclitaxel
- Thalidomid
Andere Studien-ID-Nummern
- NCI-2012-02943
- U10CA021115 (US NIH Stipendium/Vertrag)
- E3598 (Andere Kennung: Eastern Cooperative Oncology Group (ECOG))
- CDR0000067510 (Registrierungskennung: PDQ (Physician Data Query))
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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