Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Patients With Stage III Non-small Cell Lung Cancer
29. května 2014 aktualizováno: National Cancer Institute (NCI)
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)
This randomized phase III trial is studying carboplatin, paclitaxel, radiation therapy, and thalidomide to see how well they work compared to carboplatin, paclitaxel, and radiation therapy alone in treating patients with newly diagnosed stage III non-small cell lung cancer.
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Thalidomide may stop the growth of non-small cell lung cancer by stopping blood flow to the tumor.
It is not yet known if combination chemotherapy plus radiation therapy is more effective with or without thalidomide.
Přehled studie
Postavení
Ukončeno
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
589
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Pretoria, Jižní Afrika, 0001
- Pretoria Academic Hospital
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Arkansas
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Ft. Smith, Arkansas, Spojené státy, 72903
- Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
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California
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Modesto, California, Spojené státy, 95355
- Memorial Medical Center Cancer Services
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Salinas, California, Spojené státy, 93901
- Salinas Valley Memorial Hospital
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Stanford, California, Spojené státy, 94305
- Stanford Comprehensive Cancer Center at Stanford University Medical Center
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Colorado
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Aurora, Colorado, Spojené státy, 80012
- Aurora Presbyterian Hospital
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Boulder, Colorado, Spojené státy, 80301-9019
- Boulder Community Hospital
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Colorado Springs, Colorado, Spojené státy, 80933
- Penrose Cancer Center at Penrose Hospital
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Colorado Springs, Colorado, Spojené státy, 80909
- Memorial Hospital
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Denver, Colorado, Spojené státy, 80210
- Porter Adventist Hospital
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Denver, Colorado, Spojené státy, 80220
- Rose Medical Center
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Denver, Colorado, Spojené státy, 80218
- Presbyterian - St. Luke's Medical Center
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Denver, Colorado, Spojené státy, 80218
- St. Joseph Hospital
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Denver, Colorado, Spojené státy, 80224-2522
- CCOP - Colorado Cancer Research Program, Incorporated
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Englewood, Colorado, Spojené státy, 80110
- Swedish Medical Center
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Grand Junction, Colorado, Spojené státy, 81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
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Lone Tree, Colorado, Spojené státy, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Spojené státy, 80502
- Hope Cancer Care Center at Longmont United Hospital
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Pueblo, Colorado, Spojené státy, 81004
- St. Mary-Corwin Regional Medical Center
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Thornton, Colorado, Spojené státy, 80229
- North Suburban Medical Center
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Connecticut
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Danbury, Connecticut, Spojené státy, 06810
- Praxair Cancer Center at Danbury Hospital
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Norwich, Connecticut, Spojené státy, 06360
- William W. Backus Hospital
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Florida
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Daytona Beach, Florida, Spojené státy, 32115
- Halifax Medical Center - Daytona Beach
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Jacksonville, Florida, Spojené státy, 32207
- Baptist Cancer Institute - Jacksonville
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Georgia
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Augusta, Georgia, Spojené státy, 30912
- MBCCOP - Medical College of Georgia Cancer Center
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Augusta, Georgia, Spojené státy, 30904
- Veterans Affairs Medical Center - Augusta
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Decatur, Georgia, Spojené státy, 30033
- Veterans Affairs Medical Center - Atlanta (Decatur)
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Macon, Georgia, Spojené státy, 31208
- Medical Center of Central Georgia
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Savannah, Georgia, Spojené státy, 31403-3089
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Valdosta, Georgia, Spojené státy, 31603
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
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Illinois
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Chicago, Illinois, Spojené státy, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Chicago, Illinois, Spojené státy, 60625
- Swedish Covenant Hospital
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Chicago, Illinois, Spojené státy, 60616
- Mercy Hospital and Medical Center
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Hinsdale, Illinois, Spojené státy, 60521
- Hinsdale Hematology Oncology Associates
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Joliet, Illinois, Spojené státy, 60432
- Midwest Center for Hematology/Oncology
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Moline, Illinois, Spojené státy, 61265
- Trinity Medical Center - East
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Rockford, Illinois, Spojené státy, 61104-2315
- Swedish-American Regional Cancer Center
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Skokie, Illinois, Spojené státy, 60076
- Hematology/Oncology of the North Shore at Gross Point Medical Center
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Indiana
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Elkhart, Indiana, Spojené státy, 46515
- Elkhart General Hospital
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Kokomo, Indiana, Spojené státy, 46904
- Howard Community Hospital at Howard Regional Health System
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La Porte, Indiana, Spojené státy, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Richmond, Indiana, Spojené státy, 47374
- Reid Hospital & Health Care Services, Incorporated
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South Bend, Indiana, Spojené státy, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Spojené státy, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, Spojené státy, 46617
- Saint Joseph Regional Medical Center
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Iowa
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Bettendorf, Iowa, Spojené státy, 52722
- Hematology Oncology Associates of the Quad Cities
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Cedar Rapids, Iowa, Spojené státy, 52402
- St. Luke's Hospital
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Cedar Rapids, Iowa, Spojené státy, 52403
- Cedar Rapids Oncology Associates
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Cedar Rapids, Iowa, Spojené státy, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Davenport, Iowa, Spojené státy, 52803
- Genesis Regional Cancer Center at Genesis Medical Center
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Des Moines, Iowa, Spojené státy, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Spojené státy, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Spojené státy, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Spojené státy, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Spojené státy, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Spojené státy, 50307
- Mercy Capitol Hospital
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Des Moines, Iowa, Spojené státy, 50316-2301
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Sioux City, Iowa, Spojené státy, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Spojené státy, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, Spojené státy, 51104
- Mercy Medical Center - Sioux City
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West Des Moines, Iowa, Spojené státy, 50266
- Medical Oncology and Hematology Associates - West Des Moines
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Kentucky
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Madisonville, Kentucky, Spojené státy, 42431
- Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
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Maryland
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Annapolis, Maryland, Spojené státy, 21401
- DeCesaris Cancer Institute at Anne Arundel Medical Center
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02111
- Tufts-NEMC Cancer Center
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Newton, Massachusetts, Spojené státy, 02462
- Newton-Wellesley Hospital
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Springfield, Massachusetts, Spojené státy, 01199
- Baystate Regional Cancer Program at D'Amour Center for Cancer Care
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Taunton, Massachusetts, Spojené státy, 02780
- Morton Hospital & Medical Center
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Michigan
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Adrian, Michigan, Spojené státy, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, Spojené státy, 48106
- CCOP - Michigan Cancer Research Consortium
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Ann Arbor, Michigan, Spojené státy, 48106-0995
- St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
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Dearborn, Michigan, Spojené státy, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Escanaba, Michigan, Spojené státy, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, Spojené státy, 48503
- Hurley Medical Center
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Flint, Michigan, Spojené státy, 48503
- Genesys Hurley Cancer Institute
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Grosse Pointe Woods, Michigan, Spojené státy, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Iron Mountain, Michigan, Spojené státy, 49801
- Green Bay Oncology, Limited - Iron Mountain
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Jackson, Michigan, Spojené státy, 49201
- Foote Hospital
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Kalamazoo, Michigan, Spojené státy, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Spojené státy, 49007-3731
- West Michigan Cancer Center
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Kalamazooaa, Michigan, Spojené státy, 49001
- Borgess Medical Center
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Lambertville, Michigan, Spojené státy, 48144
- Haematology-Oncology Associates of Ohio and Michigan, PC
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Lansing, Michigan, Spojené státy, 48909
- Sparrow Regional Cancer Center
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Monroe, Michigan, Spojené státy, 48162
- Mercy Memorial Hospital System
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Saginaw, Michigan, Spojené státy, 48601
- Seton Cancer Institute - Saginaw
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St. Joseph, Michigan, Spojené státy, 49085
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
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Warren, Michigan, Spojené státy, 48093
- St. John Macomb Hospital
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Minnesota
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Burnsville, Minnesota, Spojené státy, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Spojené státy, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Spojené státy, 55805
- CCOP - Duluth
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Duluth, Minnesota, Spojené státy, 55805
- St. Mary's - Duluth Clinic Cancer Center
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Duluth, Minnesota, Spojené státy, 55805
- Miller-Dwan Medical Center
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Edina, Minnesota, Spojené státy, 55435
- Fairview Southdale Hospital
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Fergus Falls, Minnesota, Spojené státy, 56537
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Fridley, Minnesota, Spojené státy, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Spojené státy, 55350
- Hutchinson Area Health Care
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Lichfield, Minnesota, Spojené státy, 55355
- Meeker County Memorial Hospital
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Maplewood, Minnesota, Spojené státy, 55109
- HealthEast Cancer Care at St. John's Hospital
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Minneapolis, Minnesota, Spojené státy, 55415
- Hennepin County Medical Center - Minneapolis
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Minneapolis, Minnesota, Spojené státy, 55407
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
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Robbinsdale, Minnesota, Spojené státy, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
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Saint Louis Park, Minnesota, Spojené státy, 55416
- CCOP - Metro-Minnesota
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Shakopee, Minnesota, Spojené státy, 55379
- Saint Francis Cancer Center
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St Paul, Minnesota, Spojené státy, 55102
- St. Joseph's Hospital
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St. Cloud, Minnesota, Spojené státy, 56303
- CentraCare Clinic - River Campus
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St. Louis Park, Minnesota, Spojené státy, 55416
- Park Nicollet Health Services
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St. Paul, Minnesota, Spojené státy, 55102
- United Hospital
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St. Paul, Minnesota, Spojené státy, 55101
- Regions Hospital Cancer Care Center
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Waconia, Minnesota, Spojené státy, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, Spojené státy, 55125
- Woodwinds Health Campus
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Missouri
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Kansas City, Missouri, Spojené státy, 64131
- CCOP - Kansas City
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Springfield, Missouri, Spojené státy, 65804
- St. John's Regional Health Center
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Springfield, Missouri, Spojené státy, 65807
- Hulston Cancer Center at Cox Medical Center South
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St. Louis, Missouri, Spojené státy, 63131
- Missouri Baptist Cancer Center
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Montana
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Billings, Montana, Spojené státy, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, Spojené státy, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, Spojené státy, 59107-7000
- Deaconess Billings Clinic - Downtown
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Great Falls, Montana, Spojené státy, 59405
- Great Falls Clinic
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Great Falls, Montana, Spojené státy, 59405
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Great Falls, Montana, Spojené státy, 59405
- Big Sky Oncology
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Great Falls, Montana, Spojené státy, 59405
- Sletten Regional Cancer Institute at Benefis Healthcare
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Nebraska
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Lincoln, Nebraska, Spojené státy, 68510
- Cancer Resource Center - Lincoln
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Omaha, Nebraska, Spojené státy, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Spojené státy, 68122
- Immanuel Medical Center
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Omaha, Nebraska, Spojené státy, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
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Omaha, Nebraska, Spojené státy, 68131-2197
- Creighton University Medical Center
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Nevada
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Las Vegas, Nevada, Spojené státy, 89106
- CCOP - Nevada Cancer Research Foundation
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New Jersey
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East Orange, New Jersey, Spojené státy, 07018-1095
- Veterans Affairs Medical Center - East Orange
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Flemington, New Jersey, Spojené státy, 08822
- Hunterdon Regional Cancer Center at Hunterdon Medical Center
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Hamilton, New Jersey, Spojené státy, 08690
- Cancer Institute of New Jersey At Hamilton
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Marlton, New Jersey, Spojené státy, 08053
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
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Montclair, New Jersey, Spojené státy, 07042
- Mountainside Hospital Cancer Center
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Morristown, New Jersey, Spojené státy, 07962
- Carol G. Simon Cancer Center at Morristown Memorial Hospital
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New Brunswick, New Jersey, Spojené státy, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Phillipsburg, New Jersey, Spojené státy, 08865
- Warren Hospital
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Red Bank, New Jersey, Spojené státy, 07701
- Booker Cancer Center at Riverview Medical Center
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Somers Point, New Jersey, Spojené státy, 08244
- Shore Memorial Hospital - Somers Point
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Summit, New Jersey, Spojené státy, 07902
- Overlook Hospital
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Voorhees, New Jersey, Spojené státy, 08043
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
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New York
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Bronx, New York, Spojené státy, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Bronx, New York, Spojené státy, 10466
- Our Lady of Mercy Medical Center Comprehensive Cancer Center
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Buffalo, New York, Spojené státy, 14215
- Veterans Affairs Medical Center - Buffalo
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Rochester, New York, Spojené státy, 14621
- Lipson Cancer and Blood Center at Rochester General Hospital
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Syracuse, New York, Spojené státy, 13057
- CCOP - Hematology-Oncology Associates of Central New York
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North Carolina
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Goldsboro, North Carolina, Spojené státy, 27534
- Wayne Memorial Hospital, Incorporated
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Wilson, North Carolina, Spojené státy, 27893-3428
- Wilson Medical Center
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North Dakota
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Bismarck, North Dakota, Spojené státy, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, Spojené státy, 58501
- Cancer Care Center at Medcenter One Hospital
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Bismarck, North Dakota, Spojené státy, 58501
- Mid Dakota Clinic, P. C.
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Bismarck, North Dakota, Spojené státy, 58502
- St. Alexius Medical Center
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Ohio
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Akron, Ohio, Spojené státy, 44309-2090
- Akron City Hospital
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Canton, Ohio, Spojené státy, 44710-1799
- Aultman Hospital Cancer Center at Aultman Health Foundation
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Chillicothe, Ohio, Spojené státy, 45601
- Adena Regional Medical Center
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Cleveland, Ohio, Spojené státy, 44109
- MetroHealth's Cancer Care Center at MetroHealth Medical Center
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Columbus, Ohio, Spojené státy, 43214-3998
- Riverside Methodist Hospital Cancer Care
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Columbus, Ohio, Spojené státy, 43222
- Mount Carmel Health - West Hospital
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Columbus, Ohio, Spojené státy, 43215
- CCOP - Columbus
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Columbus, Ohio, Spojené státy, 43228
- Doctors Hospital at Ohio Health
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Columbus, Ohio, Spojené státy, 43215
- Grant Riverside Cancer Services
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Dayton, Ohio, Spojené státy, 45428
- Veterans Affairs Medical Center - Dayton
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Dayton, Ohio, Spojené státy, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
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Dayton, Ohio, Spojené státy, 45415
- Samaritan North Cancer Care Center
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Delaware, Ohio, Spojené státy, 43015
- Grady Memorial Hospital
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Findlay, Ohio, Spojené státy, 45840
- Blanchard Valley Medical Associates
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Fremont, Ohio, Spojené státy, 43420
- Fremont Memorial Hospital
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Kettering, Ohio, Spojené státy, 45429
- Charles F. Kettering Memorial Hospital
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Lancaster, Ohio, Spojené státy, 43130
- Fairfield Medical Center
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Lima, Ohio, Spojené státy, 45804
- Lima Memorial Hospital
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Lima, Ohio, Spojené státy, 45801
- St. Rita's Medical Center
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Mansfield, Ohio, Spojené státy, 44903
- MedCentral - Mansfield Hospital
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Marietta, Ohio, Spojené státy, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
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Maumee, Ohio, Spojené státy, 43537
- St. Luke's Hospital
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Maumee, Ohio, Spojené státy, 43623
- Northwest Ohio Oncology Center
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Newark, Ohio, Spojené státy, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
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Oregon, Ohio, Spojené státy, 43616
- St. Charles Mercy Hospital
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Sandusky, Ohio, Spojené státy, 44870
- Firelands Regional Medical Center
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Springfield, Ohio, Spojené státy, 45505
- Community Hospital of Springfield and Clark County
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Springfield, Ohio, Spojené státy, 45504
- Mercy Medical Center
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Sylvania, Ohio, Spojené státy, 43560
- Flower Hospital Cancer Center
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Tiffin, Ohio, Spojené státy, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, Spojené státy, 43608
- St. Vincent Mercy Medical Center
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Toledo, Ohio, Spojené státy, 43606
- Toledo Hospital
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Toledo, Ohio, Spojené státy, 43614
- Medical University of Ohio Cancer Center
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Toledo, Ohio, Spojené státy, 43623
- Toledo Clinic, Incorporated - Main Clinic
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Toledo, Ohio, Spojené státy, 43623
- CCOP - Toledo Community Hospital
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Troy, Ohio, Spojené státy, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
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Wauseon, Ohio, Spojené státy, 43567
- Fulton County Health Center
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Pennsylvania
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Allentown, Pennsylvania, Spojené státy, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
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Bryn Mawr, Pennsylvania, Spojené státy, 19010
- Bryn Mawr Hospital
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Danville, Pennsylvania, Spojené státy, 17822-0001
- Geisinger Medical Center
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Dubois, Pennsylvania, Spojené státy, 15801
- Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center
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Easton, Pennsylvania, Spojené státy, 18042
- Easton Regional Cancer Center at Easton Hospital
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Harrisburg, Pennsylvania, Spojené státy, 17105
- PinnacleHealth Regional Cancer Center at Polyclinic Hospital
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Hershey, Pennsylvania, Spojené státy, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Lancaster, Pennsylvania, Spojené státy, 17604
- Lancaster General Hospital
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Lewistown, Pennsylvania, Spojené státy, 17044
- Lewistown Hospital
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Paoli, Pennsylvania, Spojené státy, 19301-1792
- Paoli Memorial Hospital
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Philadelphia, Pennsylvania, Spojené státy, 19107
- Joan Karnell Cancer Center at Pennsylvania Hospital
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Phoenixville, Pennsylvania, Spojené státy, 19460
- Cancer Center at Phoenixville Hospital
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Pittsburgh, Pennsylvania, Spojené státy, 15212
- Allegheny Cancer Center at Allegheny General Hospital
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Pittsburgh, Pennsylvania, Spojené státy, 15232
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
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Pottstown, Pennsylvania, Spojené státy, 19464
- Pottstown Memorial Regional Cancer Center
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Reading, Pennsylvania, Spojené státy, 19612-6052
- Reading Hospital and Medical Center
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Scranton, Pennsylvania, Spojené státy, 18501
- Mercy Hospital Cancer Center - Scranton
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Scranton, Pennsylvania, Spojené státy, 18510
- Hematology and Oncology Associates
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Sellersville, Pennsylvania, Spojené státy, 18960
- Grand View Hospital
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State College, Pennsylvania, Spojené státy, 16803
- Mount Nittany Medical Center
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West Grove, Pennsylvania, Spojené státy, 19390-9499
- Jennersville Regional Hospital
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Wilkes-Barre, Pennsylvania, Spojené státy, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
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Wynnewood, Pennsylvania, Spojené státy, 19096
- CCOP - MainLine Health
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Wynnewood, Pennsylvania, Spojené státy, 19096
- Lankenau Cancer Center at Lankenau Hospital
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South Carolina
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Aiken, South Carolina, Spojené státy, 29801
- Cancer Care Institute of Carolina at Aiken Regional Medical Centers
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Greenville, South Carolina, Spojené státy, 29615
- CCOP - Greenville
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South Dakota
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Sioux Falls, South Dakota, Spojené státy, 57105
- Avera Cancer Institute
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Sioux Falls, South Dakota, Spojené státy, 57117-5039
- Sioux Valley Hospital and University of South Dakota Medical Center
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Sioux Falls, South Dakota, Spojené státy, 57105
- Medical X-Ray Center, PC
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Tennessee
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Kingsport, Tennessee, Spojené státy, 37662
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
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Nashville, Tennessee, Spojené státy, 37208-3599
- MBCCOP - Meharry Medical College - Nashville
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Texas
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Temple, Texas, Spojené státy, 76508
- CCOP - Scott and White Hospital
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Virginia
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Charlottesville, Virginia, Spojené státy, 22908
- University of Virginia Cancer Center at UV Health System
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Danville, Virginia, Spojené státy, 24541
- Danville Regional Medical Center
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Norton, Virginia, Spojené státy, 24273
- Southwest Virginia Regional Cancer Center
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Richmond, Virginia, Spojené státy, 23298-0037
- Virginia Commonwealth University Massey Cancer Center
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West Virginia
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Charleston, West Virginia, Spojené státy, 25304
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
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Huntington, West Virginia, Spojené státy, 25701
- Marshall University Medical Center
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Wisconsin
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Green Bay, Wisconsin, Spojené státy, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, Spojené státy, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
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Green Bay, Wisconsin, Spojené státy, 54303
- St. Mary's Hospital Medical Center - Green Bay
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Green Bay, Wisconsin, Spojené státy, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital
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La Crosse, Wisconsin, Spojené státy, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
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Madison, Wisconsin, Spojené státy, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
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Madison, Wisconsin, Spojené státy, 53717
- Dean Medical Center - Madison
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Marinette, Wisconsin, Spojené státy, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
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Marshfield, Wisconsin, Spojené státy, 54449
- Marshfield Clinic - Marshfield Center
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Oconto Falls, Wisconsin, Spojené státy, 54154
- Green Bay Oncology, Limited - Oconto Falls
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Racine, Wisconsin, Spojené státy, 53405
- All Saints Cancer Center at All Saints Healthcare
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Sturgeon Bay, Wisconsin, Spojené státy, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
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-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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
Ostatní jména:
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
Ostatní jména:
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
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
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
Ostatní jména:
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
Ostatní jména:
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.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Overall Survival Time
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time to Disease Progression
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Studijní židle: Joan H. Schiller, MD, Simmons Cancer Center
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. ledna 2000
Primární dokončení (Aktuální)
1. prosince 2009
Dokončení studie (Aktuální)
1. března 2010
Termíny zápisu do studia
První předloženo
7. března 2000
První předloženo, které splnilo kritéria kontroly kvality
26. ledna 2003
První zveřejněno (Odhad)
27. ledna 2003
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
2. června 2014
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
29. května 2014
Naposledy ověřeno
1. února 2013
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Nemoci dýchacích cest
- Novotvary
- Plicní onemocnění
- Novotvary podle místa
- Novotvary dýchacího traktu
- Novotvary hrudníku
- Karcinom, Bronchogenní
- Bronchiální novotvary
- Novotvary plic
- Karcinom, nemalobuněčné plíce
- Fyziologické účinky léků
- Molekulární mechanismy farmakologického působení
- Antiinfekční látky
- Antineoplastická činidla
- Imunosupresivní látky
- Imunologické faktory
- Tubulinové modulátory
- Antimitotické látky
- Modulátory mitózy
- Antineoplastické látky, fytogenní
- Inhibitory angiogeneze
- Činidla modulující angiogenezi
- Růstové látky
- Inhibitory růstu
- Antibakteriální látky
- Leprostatická činidla
- Karboplatina
- Paklitaxel
- Thalidomid
Další identifikační čísla studie
- NCI-2012-02943
- U10CA021115 (Grant/smlouva NIH USA)
- E3598 (Jiný identifikátor: Eastern Cooperative Oncology Group (ECOG))
- CDR0000067510 (Identifikátor registru: PDQ (Physician Data Query))
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .