Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Patients With Stage III Non-small Cell Lung Cancer
29. maj 2014 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
589
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arkansas
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Ft. Smith, Arkansas, Forenede Stater, 72903
- Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
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California
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Modesto, California, Forenede Stater, 95355
- Memorial Medical Center Cancer Services
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Salinas, California, Forenede Stater, 93901
- Salinas Valley Memorial Hospital
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Stanford, California, Forenede Stater, 94305
- Stanford Comprehensive Cancer Center at Stanford University Medical Center
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Colorado
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Aurora, Colorado, Forenede Stater, 80012
- Aurora Presbyterian Hospital
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Boulder, Colorado, Forenede Stater, 80301-9019
- Boulder Community Hospital
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Colorado Springs, Colorado, Forenede Stater, 80933
- Penrose Cancer Center at Penrose Hospital
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Colorado Springs, Colorado, Forenede Stater, 80909
- Memorial Hospital
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Denver, Colorado, Forenede Stater, 80210
- Porter Adventist Hospital
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Denver, Colorado, Forenede Stater, 80220
- Rose Medical Center
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Denver, Colorado, Forenede Stater, 80218
- Presbyterian - St. Luke's Medical Center
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Denver, Colorado, Forenede Stater, 80218
- St. Joseph Hospital
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Denver, Colorado, Forenede Stater, 80224-2522
- CCOP - Colorado Cancer Research Program, Incorporated
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Englewood, Colorado, Forenede Stater, 80110
- Swedish Medical Center
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Grand Junction, Colorado, Forenede Stater, 81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
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Lone Tree, Colorado, Forenede Stater, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Forenede Stater, 80502
- Hope Cancer Care Center at Longmont United Hospital
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Pueblo, Colorado, Forenede Stater, 81004
- St. Mary-Corwin Regional Medical Center
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Thornton, Colorado, Forenede Stater, 80229
- North Suburban Medical Center
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Connecticut
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Danbury, Connecticut, Forenede Stater, 06810
- Praxair Cancer Center at Danbury Hospital
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Norwich, Connecticut, Forenede Stater, 06360
- William W. Backus Hospital
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Florida
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Daytona Beach, Florida, Forenede Stater, 32115
- Halifax Medical Center - Daytona Beach
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Jacksonville, Florida, Forenede Stater, 32207
- Baptist Cancer Institute - Jacksonville
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Georgia
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Augusta, Georgia, Forenede Stater, 30912
- MBCCOP - Medical College of Georgia Cancer Center
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Augusta, Georgia, Forenede Stater, 30904
- Veterans Affairs Medical Center - Augusta
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Decatur, Georgia, Forenede Stater, 30033
- Veterans Affairs Medical Center - Atlanta (Decatur)
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Macon, Georgia, Forenede Stater, 31208
- Medical Center of Central Georgia
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Savannah, Georgia, Forenede Stater, 31403-3089
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Valdosta, Georgia, Forenede Stater, 31603
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
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Illinois
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Chicago, Illinois, Forenede Stater, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Chicago, Illinois, Forenede Stater, 60625
- Swedish Covenant Hospital
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Chicago, Illinois, Forenede Stater, 60616
- Mercy Hospital and Medical Center
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Hinsdale, Illinois, Forenede Stater, 60521
- Hinsdale Hematology Oncology Associates
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Joliet, Illinois, Forenede Stater, 60432
- Midwest Center for Hematology/Oncology
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Moline, Illinois, Forenede Stater, 61265
- Trinity Medical Center - East
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Rockford, Illinois, Forenede Stater, 61104-2315
- Swedish-American Regional Cancer Center
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Skokie, Illinois, Forenede Stater, 60076
- Hematology/Oncology of the North Shore at Gross Point Medical Center
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Indiana
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Elkhart, Indiana, Forenede Stater, 46515
- Elkhart General Hospital
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Kokomo, Indiana, Forenede Stater, 46904
- Howard Community Hospital at Howard Regional Health System
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La Porte, Indiana, Forenede Stater, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Richmond, Indiana, Forenede Stater, 47374
- Reid Hospital & Health Care Services, Incorporated
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South Bend, Indiana, Forenede Stater, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Forenede Stater, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, Forenede Stater, 46617
- Saint Joseph Regional Medical Center
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Iowa
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Bettendorf, Iowa, Forenede Stater, 52722
- Hematology Oncology Associates of the Quad Cities
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Cedar Rapids, Iowa, Forenede Stater, 52402
- St. Luke's Hospital
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Cedar Rapids, Iowa, Forenede Stater, 52403
- Cedar Rapids Oncology Associates
-
Cedar Rapids, Iowa, Forenede Stater, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Davenport, Iowa, Forenede Stater, 52803
- Genesis Regional Cancer Center at Genesis Medical Center
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Des Moines, Iowa, Forenede Stater, 50309
- CCOP - Iowa Oncology Research Association
-
Des Moines, Iowa, Forenede Stater, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Forenede Stater, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Forenede Stater, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Forenede Stater, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Forenede Stater, 50307
- Mercy Capitol Hospital
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Des Moines, Iowa, Forenede Stater, 50316-2301
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Sioux City, Iowa, Forenede Stater, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Forenede Stater, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, Forenede Stater, 51104
- Mercy Medical Center - Sioux City
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West Des Moines, Iowa, Forenede Stater, 50266
- Medical Oncology and Hematology Associates - West Des Moines
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Kentucky
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Madisonville, Kentucky, Forenede Stater, 42431
- Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
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Maryland
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Annapolis, Maryland, Forenede Stater, 21401
- DeCesaris Cancer Institute at Anne Arundel Medical Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02111
- Tufts-NEMC Cancer Center
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Newton, Massachusetts, Forenede Stater, 02462
- Newton-Wellesley Hospital
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Springfield, Massachusetts, Forenede Stater, 01199
- Baystate Regional Cancer Program at D'Amour Center for Cancer Care
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Taunton, Massachusetts, Forenede Stater, 02780
- Morton Hospital & Medical Center
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Michigan
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Adrian, Michigan, Forenede Stater, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, Forenede Stater, 48106
- CCOP - Michigan Cancer Research Consortium
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Ann Arbor, Michigan, Forenede Stater, 48106-0995
- St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
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Dearborn, Michigan, Forenede Stater, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Escanaba, Michigan, Forenede Stater, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, Forenede Stater, 48503
- Hurley Medical Center
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Flint, Michigan, Forenede Stater, 48503
- Genesys Hurley Cancer Institute
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Grosse Pointe Woods, Michigan, Forenede Stater, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Iron Mountain, Michigan, Forenede Stater, 49801
- Green Bay Oncology, Limited - Iron Mountain
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Jackson, Michigan, Forenede Stater, 49201
- Foote Hospital
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Kalamazoo, Michigan, Forenede Stater, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Forenede Stater, 49007-3731
- West Michigan Cancer Center
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Kalamazooaa, Michigan, Forenede Stater, 49001
- Borgess Medical Center
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Lambertville, Michigan, Forenede Stater, 48144
- Haematology-Oncology Associates of Ohio and Michigan, PC
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Lansing, Michigan, Forenede Stater, 48909
- Sparrow Regional Cancer Center
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Monroe, Michigan, Forenede Stater, 48162
- Mercy Memorial Hospital System
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Saginaw, Michigan, Forenede Stater, 48601
- Seton Cancer Institute - Saginaw
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St. Joseph, Michigan, Forenede Stater, 49085
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
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Warren, Michigan, Forenede Stater, 48093
- St. John Macomb Hospital
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Minnesota
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Burnsville, Minnesota, Forenede Stater, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Forenede Stater, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Forenede Stater, 55805
- CCOP - Duluth
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Duluth, Minnesota, Forenede Stater, 55805
- St. Mary's - Duluth Clinic Cancer Center
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Duluth, Minnesota, Forenede Stater, 55805
- Miller-Dwan Medical Center
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Edina, Minnesota, Forenede Stater, 55435
- Fairview Southdale Hospital
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Fergus Falls, Minnesota, Forenede Stater, 56537
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Fridley, Minnesota, Forenede Stater, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Forenede Stater, 55350
- Hutchinson Area Health Care
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Lichfield, Minnesota, Forenede Stater, 55355
- Meeker County Memorial Hospital
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Maplewood, Minnesota, Forenede Stater, 55109
- HealthEast Cancer Care at St. John's Hospital
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Minneapolis, Minnesota, Forenede Stater, 55415
- Hennepin County Medical Center - Minneapolis
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Minneapolis, Minnesota, Forenede Stater, 55407
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
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Robbinsdale, Minnesota, Forenede Stater, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- CCOP - Metro-Minnesota
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Shakopee, Minnesota, Forenede Stater, 55379
- Saint Francis Cancer Center
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St Paul, Minnesota, Forenede Stater, 55102
- St. Joseph's Hospital
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St. Cloud, Minnesota, Forenede Stater, 56303
- CentraCare Clinic - River Campus
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St. Louis Park, Minnesota, Forenede Stater, 55416
- Park Nicollet Health Services
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St. Paul, Minnesota, Forenede Stater, 55102
- United Hospital
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St. Paul, Minnesota, Forenede Stater, 55101
- Regions Hospital Cancer Care Center
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Waconia, Minnesota, Forenede Stater, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, Forenede Stater, 55125
- Woodwinds Health Campus
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Missouri
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Kansas City, Missouri, Forenede Stater, 64131
- CCOP - Kansas City
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Springfield, Missouri, Forenede Stater, 65804
- St. John's Regional Health Center
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Springfield, Missouri, Forenede Stater, 65807
- Hulston Cancer Center at Cox Medical Center South
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St. Louis, Missouri, Forenede Stater, 63131
- Missouri Baptist Cancer Center
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Montana
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Billings, Montana, Forenede Stater, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, Forenede Stater, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, Forenede Stater, 59107-7000
- Deaconess Billings Clinic - Downtown
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Great Falls, Montana, Forenede Stater, 59405
- Great Falls Clinic
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Great Falls, Montana, Forenede Stater, 59405
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Great Falls, Montana, Forenede Stater, 59405
- Big Sky Oncology
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Great Falls, Montana, Forenede Stater, 59405
- Sletten Regional Cancer Institute at Benefis Healthcare
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Nebraska
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Lincoln, Nebraska, Forenede Stater, 68510
- Cancer Resource Center - Lincoln
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Omaha, Nebraska, Forenede Stater, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Forenede Stater, 68122
- Immanuel Medical Center
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Omaha, Nebraska, Forenede Stater, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
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Omaha, Nebraska, Forenede Stater, 68131-2197
- Creighton University Medical Center
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89106
- CCOP - Nevada Cancer Research Foundation
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New Jersey
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East Orange, New Jersey, Forenede Stater, 07018-1095
- Veterans Affairs Medical Center - East Orange
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Flemington, New Jersey, Forenede Stater, 08822
- Hunterdon Regional Cancer Center at Hunterdon Medical Center
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Hamilton, New Jersey, Forenede Stater, 08690
- Cancer Institute of New Jersey at Hamilton
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Marlton, New Jersey, Forenede Stater, 08053
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
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Montclair, New Jersey, Forenede Stater, 07042
- Mountainside Hospital Cancer Center
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Morristown, New Jersey, Forenede Stater, 07962
- Carol G. Simon Cancer Center at Morristown Memorial Hospital
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New Brunswick, New Jersey, Forenede Stater, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Phillipsburg, New Jersey, Forenede Stater, 08865
- Warren Hospital
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Red Bank, New Jersey, Forenede Stater, 07701
- Booker Cancer Center at Riverview Medical Center
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Somers Point, New Jersey, Forenede Stater, 08244
- Shore Memorial Hospital - Somers Point
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Summit, New Jersey, Forenede Stater, 07902
- Overlook Hospital
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Voorhees, New Jersey, Forenede Stater, 08043
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
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New York
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Bronx, New York, Forenede Stater, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Bronx, New York, Forenede Stater, 10466
- Our Lady of Mercy Medical Center Comprehensive Cancer Center
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Buffalo, New York, Forenede Stater, 14215
- Veterans Affairs Medical Center - Buffalo
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Rochester, New York, Forenede Stater, 14621
- Lipson Cancer and Blood Center at Rochester General Hospital
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Syracuse, New York, Forenede Stater, 13057
- CCOP - Hematology-Oncology Associates of Central New York
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North Carolina
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Goldsboro, North Carolina, Forenede Stater, 27534
- Wayne Memorial Hospital, Incorporated
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Wilson, North Carolina, Forenede Stater, 27893-3428
- Wilson Medical Center
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North Dakota
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Bismarck, North Dakota, Forenede Stater, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, Forenede Stater, 58501
- Cancer Care Center at Medcenter One Hospital
-
Bismarck, North Dakota, Forenede Stater, 58501
- Mid Dakota Clinic, P. C.
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Bismarck, North Dakota, Forenede Stater, 58502
- St. Alexius Medical Center
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Ohio
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Akron, Ohio, Forenede Stater, 44309-2090
- Akron City Hospital
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Canton, Ohio, Forenede Stater, 44710-1799
- Aultman Hospital Cancer Center at Aultman Health Foundation
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Chillicothe, Ohio, Forenede Stater, 45601
- Adena Regional Medical Center
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Cleveland, Ohio, Forenede Stater, 44109
- MetroHealth's Cancer Care Center at MetroHealth Medical Center
-
Columbus, Ohio, Forenede Stater, 43214-3998
- Riverside Methodist Hospital Cancer Care
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Columbus, Ohio, Forenede Stater, 43222
- Mount Carmel Health - West Hospital
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Columbus, Ohio, Forenede Stater, 43215
- CCOP - Columbus
-
Columbus, Ohio, Forenede Stater, 43228
- Doctors Hospital at Ohio Health
-
Columbus, Ohio, Forenede Stater, 43215
- Grant Riverside Cancer Services
-
Dayton, Ohio, Forenede Stater, 45428
- Veterans Affairs Medical Center - Dayton
-
Dayton, Ohio, Forenede Stater, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
-
Dayton, Ohio, Forenede Stater, 45415
- Samaritan North Cancer Care Center
-
Delaware, Ohio, Forenede Stater, 43015
- Grady Memorial Hospital
-
Findlay, Ohio, Forenede Stater, 45840
- Blanchard Valley Medical Associates
-
Fremont, Ohio, Forenede Stater, 43420
- Fremont Memorial Hospital
-
Kettering, Ohio, Forenede Stater, 45429
- Charles F. Kettering Memorial Hospital
-
Lancaster, Ohio, Forenede Stater, 43130
- Fairfield Medical Center
-
Lima, Ohio, Forenede Stater, 45804
- Lima Memorial Hospital
-
Lima, Ohio, Forenede Stater, 45801
- St. Rita's Medical Center
-
Mansfield, Ohio, Forenede Stater, 44903
- MedCentral - Mansfield Hospital
-
Marietta, Ohio, Forenede Stater, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
-
Maumee, Ohio, Forenede Stater, 43537
- St. Luke's Hospital
-
Maumee, Ohio, Forenede Stater, 43623
- Northwest Ohio Oncology Center
-
Newark, Ohio, Forenede Stater, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
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Oregon, Ohio, Forenede Stater, 43616
- St. Charles Mercy Hospital
-
Sandusky, Ohio, Forenede Stater, 44870
- Firelands Regional Medical Center
-
Springfield, Ohio, Forenede Stater, 45505
- Community Hospital of Springfield and Clark County
-
Springfield, Ohio, Forenede Stater, 45504
- Mercy Medical Center
-
Sylvania, Ohio, Forenede Stater, 43560
- Flower Hospital Cancer Center
-
Tiffin, Ohio, Forenede Stater, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, Forenede Stater, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, Forenede Stater, 43606
- Toledo Hospital
-
Toledo, Ohio, Forenede Stater, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, Forenede Stater, 43623
- Toledo Clinic, Incorporated - Main Clinic
-
Toledo, Ohio, Forenede Stater, 43623
- CCOP - Toledo Community Hospital
-
Troy, Ohio, Forenede Stater, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Wauseon, Ohio, Forenede Stater, 43567
- Fulton County Health Center
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Pennsylvania
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Allentown, Pennsylvania, Forenede Stater, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
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Bryn Mawr, Pennsylvania, Forenede Stater, 19010
- Bryn Mawr Hospital
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Danville, Pennsylvania, Forenede Stater, 17822-0001
- Geisinger Medical Center
-
Dubois, Pennsylvania, Forenede Stater, 15801
- Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center
-
Easton, Pennsylvania, Forenede Stater, 18042
- Easton Regional Cancer Center at Easton Hospital
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Harrisburg, Pennsylvania, Forenede Stater, 17105
- PinnacleHealth Regional Cancer Center at Polyclinic Hospital
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Hershey, Pennsylvania, Forenede Stater, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Lancaster, Pennsylvania, Forenede Stater, 17604
- Lancaster General Hospital
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Lewistown, Pennsylvania, Forenede Stater, 17044
- Lewistown Hospital
-
Paoli, Pennsylvania, Forenede Stater, 19301-1792
- Paoli Memorial Hospital
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Joan Karnell Cancer Center at Pennsylvania Hospital
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Phoenixville, Pennsylvania, Forenede Stater, 19460
- Cancer Center at Phoenixville Hospital
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Pittsburgh, Pennsylvania, Forenede Stater, 15212
- Allegheny Cancer Center at Allegheny General Hospital
-
Pittsburgh, Pennsylvania, Forenede Stater, 15232
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
-
Pottstown, Pennsylvania, Forenede Stater, 19464
- Pottstown Memorial Regional Cancer Center
-
Reading, Pennsylvania, Forenede Stater, 19612-6052
- Reading Hospital and Medical Center
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Scranton, Pennsylvania, Forenede Stater, 18501
- Mercy Hospital Cancer Center - Scranton
-
Scranton, Pennsylvania, Forenede Stater, 18510
- Hematology and Oncology Associates
-
Sellersville, Pennsylvania, Forenede Stater, 18960
- Grand View Hospital
-
State College, Pennsylvania, Forenede Stater, 16803
- Mount Nittany Medical Center
-
West Grove, Pennsylvania, Forenede Stater, 19390-9499
- Jennersville Regional Hospital
-
Wilkes-Barre, Pennsylvania, Forenede Stater, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
-
Wynnewood, Pennsylvania, Forenede Stater, 19096
- CCOP - MainLine Health
-
Wynnewood, Pennsylvania, Forenede Stater, 19096
- Lankenau Cancer Center at Lankenau Hospital
-
-
South Carolina
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Aiken, South Carolina, Forenede Stater, 29801
- Cancer Care Institute of Carolina at Aiken Regional Medical Centers
-
Greenville, South Carolina, Forenede Stater, 29615
- CCOP - Greenville
-
-
South Dakota
-
Sioux Falls, South Dakota, Forenede Stater, 57105
- Avera Cancer Institute
-
Sioux Falls, South Dakota, Forenede Stater, 57117-5039
- Sioux Valley Hospital and University of South Dakota Medical Center
-
Sioux Falls, South Dakota, Forenede Stater, 57105
- Medical X-Ray Center, PC
-
-
Tennessee
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Kingsport, Tennessee, Forenede Stater, 37662
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
-
Nashville, Tennessee, Forenede Stater, 37208-3599
- MBCCOP - Meharry Medical College - Nashville
-
-
Texas
-
Temple, Texas, Forenede Stater, 76508
- CCOP - Scott and White Hospital
-
-
Virginia
-
Charlottesville, Virginia, Forenede Stater, 22908
- University of Virginia Cancer Center at UV Health System
-
Danville, Virginia, Forenede Stater, 24541
- Danville Regional Medical Center
-
Norton, Virginia, Forenede Stater, 24273
- Southwest Virginia Regional Cancer Center
-
Richmond, Virginia, Forenede Stater, 23298-0037
- Virginia Commonwealth University Massey Cancer Center
-
-
West Virginia
-
Charleston, West Virginia, Forenede Stater, 25304
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
-
Huntington, West Virginia, Forenede Stater, 25701
- Marshall University Medical Center
-
-
Wisconsin
-
Green Bay, Wisconsin, Forenede Stater, 54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, Forenede Stater, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay, Wisconsin, Forenede Stater, 54303
- St. Mary's Hospital Medical Center - Green Bay
-
Green Bay, Wisconsin, Forenede Stater, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital
-
La Crosse, Wisconsin, Forenede Stater, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
-
Madison, Wisconsin, Forenede Stater, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
-
Madison, Wisconsin, Forenede Stater, 53717
- Dean Medical Center - Madison
-
Marinette, Wisconsin, Forenede Stater, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
-
Marshfield, Wisconsin, Forenede Stater, 54449
- Marshfield Clinic - Marshfield Center
-
Oconto Falls, Wisconsin, Forenede Stater, 54154
- Green Bay Oncology, Limited - Oconto Falls
-
Racine, Wisconsin, Forenede Stater, 53405
- All Saints Cancer Center at All Saints Healthcare
-
Sturgeon Bay, Wisconsin, Forenede Stater, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
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-
-
-
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Pretoria, Sydafrika, 0001
- Pretoria Academic Hospital
-
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv 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
Andre navne:
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
Andre navne:
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
Andre navne:
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Eksperimentel: 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
Andre navne:
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
Andre navne:
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
Andre navne:
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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Overall Survival Time
Tidsramme: 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
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Survival time is defined as time from study entry to death from any cause
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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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Time to Disease Progression
Tidsramme: 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
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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.
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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
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Response Rate at Best Response to Treatment
Tidsramme: 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
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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.
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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
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Joan H. Schiller, MD, Simmons Cancer Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2000
Primær færdiggørelse (Faktiske)
1. december 2009
Studieafslutning (Faktiske)
1. marts 2010
Datoer for studieregistrering
Først indsendt
7. marts 2000
Først indsendt, der opfyldte QC-kriterier
26. januar 2003
Først opslået (Skøn)
27. januar 2003
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
2. juni 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. maj 2014
Sidst verificeret
1. februar 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Antibakterielle midler
- Leprostatiske midler
- Carboplatin
- Paclitaxel
- Thalidomid
Andre undersøgelses-id-numre
- NCI-2012-02943
- U10CA021115 (U.S. NIH-bevilling/kontrakt)
- E3598 (Anden identifikator: Eastern Cooperative Oncology Group (ECOG))
- CDR0000067510 (Registry Identifier: PDQ (Physician Data Query))
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Lungekræft
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Mansoura UniversityRekrutteringOne Lung VentilationEgypten
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Chinese Chronic Respiratory Disease Research NetworkRekruttering
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Dokuz Eylul UniversityAfsluttetOne Lung VentilationKalkun
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Seoul National University HospitalAfsluttet
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Seoul National University HospitalAfsluttet
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Yonsei UniversityAfsluttetOne Lung VentilationKorea, Republikken
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Sichuan UniversityWest China HospitalMidlertidigt ikke tilgængeligOne Lung Ventilation
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Joseph D. TobiasAfsluttetOne-lung Ventilation (OLV)Forenede Stater
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University Health Network, TorontoAktiv, ikke rekrutterende
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Papa Giovanni XXIII HospitalAfsluttetLungetransplantation | Ex Vivo Lung PerfusionItalien
Kliniske forsøg med carboplatin
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Eisai Inc.AfsluttetKræftForenede Stater, Østrig, Indien
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Samyang Biopharmaceuticals CorporationAfsluttet
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NHS Greater Glasgow and ClydeAfsluttetLivmoderhalskræft | Æggelederkræft | Primær peritoneal kræftDet Forenede Kongerige, Australien, New Zealand
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Duke UniversityAfsluttetTumorer i hjernen og centralnervesystemetForenede Stater, Canada
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National Cancer Institute (NCI)AfsluttetBrystkræft | LivmoderhalskræftForenede Stater
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Medical Research CouncilEuropean Organisation for Research and Treatment of Cancer - EORTCAfsluttetTestikulær kimcelletumorDet Forenede Kongerige, Canada, Norge, Holland, Sydafrika, Brasilien, Finland
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National Cancer Institute (NCI)Children's Oncology GroupAfsluttetTumorer i hjernen og centralnervesystemetForenede Stater, Canada, Puerto Rico, Australien, Holland, New Zealand, Schweiz
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All India Institute of Medical Sciences, New DelhiCouncil of Scientific and Industrial Research, IndiaUkendtIntraokulært retinoblastomIndien
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H. Lee Moffitt Cancer Center and Research InstituteNational Cancer Institute (NCI)AfsluttetUspecificeret fast tumor hos voksne, protokolspecifikForenede Stater
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Eli Lilly and CompanyAfsluttetLungeneoplasmerForenede Stater