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Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Patients With Stage III Non-small Cell Lung Cancer

29 maja 2014 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Rzeczywisty)

589

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Afryka Południowa
      • Pretoria, Afryka Południowa, 0001
        • Pretoria Academic Hospital
  • Stany Zjednoczone
    • Arkansas
      • Ft. Smith, Arkansas, Stany Zjednoczone, 72903
        • Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
    • California
      • Modesto, California, Stany Zjednoczone, 95355
        • Memorial Medical Center Cancer Services
      • Salinas, California, Stany Zjednoczone, 93901
        • Salinas Valley Memorial Hospital
      • Stanford, California, Stany Zjednoczone, 94305
        • Stanford Comprehensive Cancer Center at Stanford University Medical Center
    • Colorado
      • Aurora, Colorado, Stany Zjednoczone, 80012
        • Aurora Presbyterian Hospital
      • Boulder, Colorado, Stany Zjednoczone, 80301-9019
        • Boulder Community Hospital
      • Colorado Springs, Colorado, Stany Zjednoczone, 80933
        • Penrose Cancer Center at Penrose Hospital
      • Colorado Springs, Colorado, Stany Zjednoczone, 80909
        • Memorial Hospital
      • Denver, Colorado, Stany Zjednoczone, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, Stany Zjednoczone, 80220
        • Rose Medical Center
      • Denver, Colorado, Stany Zjednoczone, 80218
        • Presbyterian - St. Luke's Medical Center
      • Denver, Colorado, Stany Zjednoczone, 80218
        • St. Joseph Hospital
      • Denver, Colorado, Stany Zjednoczone, 80224-2522
        • CCOP - Colorado Cancer Research Program, Incorporated
      • Englewood, Colorado, Stany Zjednoczone, 80110
        • Swedish Medical Center
      • Grand Junction, Colorado, Stany Zjednoczone, 81502
        • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
      • Lone Tree, Colorado, Stany Zjednoczone, 80124
        • Sky Ridge Medical Center
      • Longmont, Colorado, Stany Zjednoczone, 80502
        • Hope Cancer Care Center at Longmont United Hospital
      • Pueblo, Colorado, Stany Zjednoczone, 81004
        • St. Mary-Corwin Regional Medical Center
      • Thornton, Colorado, Stany Zjednoczone, 80229
        • North Suburban Medical Center
    • Connecticut
      • Danbury, Connecticut, Stany Zjednoczone, 06810
        • Praxair Cancer Center at Danbury Hospital
      • Norwich, Connecticut, Stany Zjednoczone, 06360
        • William W. Backus Hospital
    • Florida
      • Daytona Beach, Florida, Stany Zjednoczone, 32115
        • Halifax Medical Center - Daytona Beach
      • Jacksonville, Florida, Stany Zjednoczone, 32207
        • Baptist Cancer Institute - Jacksonville
    • Georgia
      • Augusta, Georgia, Stany Zjednoczone, 30912
        • MBCCOP - Medical College of Georgia Cancer Center
      • Augusta, Georgia, Stany Zjednoczone, 30904
        • Veterans Affairs Medical Center - Augusta
      • Decatur, Georgia, Stany Zjednoczone, 30033
        • Veterans Affairs Medical Center - Atlanta (Decatur)
      • Macon, Georgia, Stany Zjednoczone, 31208
        • Medical Center of Central Georgia
      • Savannah, Georgia, Stany Zjednoczone, 31403-3089
        • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
      • Valdosta, Georgia, Stany Zjednoczone, 31603
        • Pearlman Comprehensive Cancer Center at South Georgia Medical Center
    • Illinois
      • Chicago, Illinois, Stany Zjednoczone, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
      • Chicago, Illinois, Stany Zjednoczone, 60625
        • Swedish Covenant Hospital
      • Chicago, Illinois, Stany Zjednoczone, 60616
        • Mercy Hospital and Medical Center
      • Hinsdale, Illinois, Stany Zjednoczone, 60521
        • Hinsdale Hematology Oncology Associates
      • Joliet, Illinois, Stany Zjednoczone, 60432
        • Midwest Center for Hematology/Oncology
      • Moline, Illinois, Stany Zjednoczone, 61265
        • Trinity Medical Center - East
      • Rockford, Illinois, Stany Zjednoczone, 61104-2315
        • Swedish-American Regional Cancer Center
      • Skokie, Illinois, Stany Zjednoczone, 60076
        • Hematology/Oncology of the North Shore at Gross Point Medical Center
    • Indiana
      • Elkhart, Indiana, Stany Zjednoczone, 46515
        • Elkhart General Hospital
      • Kokomo, Indiana, Stany Zjednoczone, 46904
        • Howard Community Hospital at Howard Regional Health System
      • La Porte, Indiana, Stany Zjednoczone, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Richmond, Indiana, Stany Zjednoczone, 47374
        • Reid Hospital & Health Care Services, Incorporated
      • South Bend, Indiana, Stany Zjednoczone, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, Stany Zjednoczone, 46601
        • CCOP - Northern Indiana CR Consortium
      • South Bend, Indiana, Stany Zjednoczone, 46617
        • Saint Joseph Regional Medical Center
    • Iowa
      • Bettendorf, Iowa, Stany Zjednoczone, 52722
        • Hematology Oncology Associates of the Quad Cities
      • Cedar Rapids, Iowa, Stany Zjednoczone, 52402
        • St. Luke's Hospital
      • Cedar Rapids, Iowa, Stany Zjednoczone, 52403
        • Cedar Rapids Oncology Associates
      • Cedar Rapids, Iowa, Stany Zjednoczone, 52403
        • Mercy Regional Cancer Center at Mercy Medical Center
      • Davenport, Iowa, Stany Zjednoczone, 52803
        • Genesis Regional Cancer Center at Genesis Medical Center
      • Des Moines, Iowa, Stany Zjednoczone, 50309
        • CCOP - Iowa Oncology Research Association
      • Des Moines, Iowa, Stany Zjednoczone, 50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Des Moines, Iowa, Stany Zjednoczone, 50309
        • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
      • Des Moines, Iowa, Stany Zjednoczone, 50314
        • Medical Oncology and Hematology Associates at Mercy Cancer Center
      • Des Moines, Iowa, Stany Zjednoczone, 50314
        • Mercy Cancer Center at Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Stany Zjednoczone, 50307
        • Mercy Capitol Hospital
      • Des Moines, Iowa, Stany Zjednoczone, 50316-2301
        • John Stoddard Cancer Center at Iowa Lutheran Hospital
      • Sioux City, Iowa, Stany Zjednoczone, 51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City, Iowa, Stany Zjednoczone, 51104
        • St. Luke's Regional Medical Center
      • Sioux City, Iowa, Stany Zjednoczone, 51104
        • Mercy Medical Center - Sioux City
      • West Des Moines, Iowa, Stany Zjednoczone, 50266
        • Medical Oncology and Hematology Associates - West Des Moines
    • Kentucky
      • Madisonville, Kentucky, Stany Zjednoczone, 42431
        • Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
    • Maryland
      • Annapolis, Maryland, Stany Zjednoczone, 21401
        • DeCesaris Cancer Institute at Anne Arundel Medical Center
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02111
        • Tufts-NEMC Cancer Center
      • Newton, Massachusetts, Stany Zjednoczone, 02462
        • Newton-Wellesley Hospital
      • Springfield, Massachusetts, Stany Zjednoczone, 01199
        • Baystate Regional Cancer Program at D'Amour Center for Cancer Care
      • Taunton, Massachusetts, Stany Zjednoczone, 02780
        • Morton Hospital & Medical Center
    • Michigan
      • Adrian, Michigan, Stany Zjednoczone, 49221
        • Hickman Cancer Center at Bixby Medical Center
      • Ann Arbor, Michigan, Stany Zjednoczone, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Ann Arbor, Michigan, Stany Zjednoczone, 48106-0995
        • St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
      • Dearborn, Michigan, Stany Zjednoczone, 48123-2500
        • Oakwood Cancer Center at Oakwood Hospital and Medical Center
      • Escanaba, Michigan, Stany Zjednoczone, 49431
        • Green Bay Oncology, Limited - Escanaba
      • Flint, Michigan, Stany Zjednoczone, 48503
        • Hurley Medical Center
      • Flint, Michigan, Stany Zjednoczone, 48503
        • Genesys Hurley Cancer Institute
      • Grosse Pointe Woods, Michigan, Stany Zjednoczone, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Iron Mountain, Michigan, Stany Zjednoczone, 49801
        • Green Bay Oncology, Limited - Iron Mountain
      • Jackson, Michigan, Stany Zjednoczone, 49201
        • Foote Hospital
      • Kalamazoo, Michigan, Stany Zjednoczone, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, Stany Zjednoczone, 49007-3731
        • West Michigan Cancer Center
      • Kalamazooaa, Michigan, Stany Zjednoczone, 49001
        • Borgess Medical Center
      • Lambertville, Michigan, Stany Zjednoczone, 48144
        • Haematology-Oncology Associates of Ohio and Michigan, PC
      • Lansing, Michigan, Stany Zjednoczone, 48909
        • Sparrow Regional Cancer Center
      • Monroe, Michigan, Stany Zjednoczone, 48162
        • Mercy Memorial Hospital System
      • Saginaw, Michigan, Stany Zjednoczone, 48601
        • Seton Cancer Institute - Saginaw
      • St. Joseph, Michigan, Stany Zjednoczone, 49085
        • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
      • Warren, Michigan, Stany Zjednoczone, 48093
        • St. John Macomb Hospital
    • Minnesota
      • Burnsville, Minnesota, Stany Zjednoczone, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Stany Zjednoczone, 55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Duluth, Minnesota, Stany Zjednoczone, 55805
        • CCOP - Duluth
      • Duluth, Minnesota, Stany Zjednoczone, 55805
        • St. Mary's - Duluth Clinic Cancer Center
      • Duluth, Minnesota, Stany Zjednoczone, 55805
        • Miller-Dwan Medical Center
      • Edina, Minnesota, Stany Zjednoczone, 55435
        • Fairview Southdale Hospital
      • Fergus Falls, Minnesota, Stany Zjednoczone, 56537
      • Fridley, Minnesota, Stany Zjednoczone, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Hutchinson, Minnesota, Stany Zjednoczone, 55350
        • Hutchinson Area Health Care
      • Lichfield, Minnesota, Stany Zjednoczone, 55355
        • Meeker County Memorial Hospital
      • Maplewood, Minnesota, Stany Zjednoczone, 55109
        • HealthEast Cancer Care at St. John's Hospital
      • Minneapolis, Minnesota, Stany Zjednoczone, 55415
        • Hennepin County Medical Center - Minneapolis
      • Minneapolis, Minnesota, Stany Zjednoczone, 55407
        • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
      • Robbinsdale, Minnesota, Stany Zjednoczone, 55422-2900
        • Hubert H. Humphrey Cancer Center at North Memorial Medical Center
      • Saint Louis Park, Minnesota, Stany Zjednoczone, 55416
        • CCOP - Metro-Minnesota
      • Shakopee, Minnesota, Stany Zjednoczone, 55379
        • Saint Francis Cancer Center
      • St Paul, Minnesota, Stany Zjednoczone, 55102
        • St. Joseph's Hospital
      • St. Cloud, Minnesota, Stany Zjednoczone, 56303
        • CentraCare Clinic - River Campus
      • St. Louis Park, Minnesota, Stany Zjednoczone, 55416
        • Park Nicollet Health Services
      • St. Paul, Minnesota, Stany Zjednoczone, 55102
        • United Hospital
      • St. Paul, Minnesota, Stany Zjednoczone, 55101
        • Regions Hospital Cancer Care Center
      • Waconia, Minnesota, Stany Zjednoczone, 55387
        • Ridgeview Medical Center
      • Woodbury, Minnesota, Stany Zjednoczone, 55125
        • Woodwinds Health Campus
    • Missouri
      • Kansas City, Missouri, Stany Zjednoczone, 64131
        • CCOP - Kansas City
      • Springfield, Missouri, Stany Zjednoczone, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, Stany Zjednoczone, 65807
        • Hulston Cancer Center at Cox Medical Center South
      • St. Louis, Missouri, Stany Zjednoczone, 63131
        • Missouri Baptist Cancer Center
    • Montana
      • Billings, Montana, Stany Zjednoczone, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, Stany Zjednoczone, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, Stany Zjednoczone, 59107-7000
        • Deaconess Billings Clinic - Downtown
      • Great Falls, Montana, Stany Zjednoczone, 59405
        • Great Falls Clinic
      • Great Falls, Montana, Stany Zjednoczone, 59405
      • Great Falls, Montana, Stany Zjednoczone, 59405
        • Big Sky Oncology
      • Great Falls, Montana, Stany Zjednoczone, 59405
        • Sletten Regional Cancer Institute at Benefis Healthcare
    • Nebraska
      • Lincoln, Nebraska, Stany Zjednoczone, 68510
        • Cancer Resource Center - Lincoln
      • Omaha, Nebraska, Stany Zjednoczone, 68106
        • CCOP - Missouri Valley Cancer Consortium
      • Omaha, Nebraska, Stany Zjednoczone, 68122
        • Immanuel Medical Center
      • Omaha, Nebraska, Stany Zjednoczone, 68124
        • Alegant Health Cancer Center at Bergan Mercy Medical Center
      • Omaha, Nebraska, Stany Zjednoczone, 68131-2197
        • Creighton University Medical Center
    • Nevada
      • Las Vegas, Nevada, Stany Zjednoczone, 89106
        • CCOP - Nevada Cancer Research Foundation
    • New Jersey
      • East Orange, New Jersey, Stany Zjednoczone, 07018-1095
        • Veterans Affairs Medical Center - East Orange
      • Flemington, New Jersey, Stany Zjednoczone, 08822
        • Hunterdon Regional Cancer Center at Hunterdon Medical Center
      • Hamilton, New Jersey, Stany Zjednoczone, 08690
        • Cancer Institute of New Jersey At Hamilton
      • Marlton, New Jersey, Stany Zjednoczone, 08053
        • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
      • Montclair, New Jersey, Stany Zjednoczone, 07042
        • Mountainside Hospital Cancer Center
      • Morristown, New Jersey, Stany Zjednoczone, 07962
        • Carol G. Simon Cancer Center at Morristown Memorial Hospital
      • New Brunswick, New Jersey, Stany Zjednoczone, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
      • Phillipsburg, New Jersey, Stany Zjednoczone, 08865
        • Warren Hospital
      • Red Bank, New Jersey, Stany Zjednoczone, 07701
        • Booker Cancer Center at Riverview Medical Center
      • Somers Point, New Jersey, Stany Zjednoczone, 08244
        • Shore Memorial Hospital - Somers Point
      • Summit, New Jersey, Stany Zjednoczone, 07902
        • Overlook Hospital
      • Voorhees, New Jersey, Stany Zjednoczone, 08043
        • Fox Chase Virtua Health Cancer Program at Virtua West Jersey
    • New York
      • Bronx, New York, Stany Zjednoczone, 10461
        • Albert Einstein Cancer Center at Albert Einstein College of Medicine
      • Bronx, New York, Stany Zjednoczone, 10466
        • Our Lady of Mercy Medical Center Comprehensive Cancer Center
      • Buffalo, New York, Stany Zjednoczone, 14215
        • Veterans Affairs Medical Center - Buffalo
      • Rochester, New York, Stany Zjednoczone, 14621
        • Lipson Cancer and Blood Center at Rochester General Hospital
      • Syracuse, New York, Stany Zjednoczone, 13057
        • CCOP - Hematology-Oncology Associates of Central New York
    • North Carolina
      • Goldsboro, North Carolina, Stany Zjednoczone, 27534
        • Wayne Memorial Hospital, Incorporated
      • Wilson, North Carolina, Stany Zjednoczone, 27893-3428
        • Wilson Medical Center
    • North Dakota
      • Bismarck, North Dakota, Stany Zjednoczone, 58501
        • Bismarck Cancer Center
      • Bismarck, North Dakota, Stany Zjednoczone, 58501
        • Cancer Care Center at Medcenter One Hospital
      • Bismarck, North Dakota, Stany Zjednoczone, 58501
        • Mid Dakota Clinic, P. C.
      • Bismarck, North Dakota, Stany Zjednoczone, 58502
        • St. Alexius Medical Center
    • Ohio
      • Akron, Ohio, Stany Zjednoczone, 44309-2090
        • Akron City Hospital
      • Canton, Ohio, Stany Zjednoczone, 44710-1799
        • Aultman Hospital Cancer Center at Aultman Health Foundation
      • Chillicothe, Ohio, Stany Zjednoczone, 45601
        • Adena Regional Medical Center
      • Cleveland, Ohio, Stany Zjednoczone, 44109
        • MetroHealth's Cancer Care Center at MetroHealth Medical Center
      • Columbus, Ohio, Stany Zjednoczone, 43214-3998
        • Riverside Methodist Hospital Cancer Care
      • Columbus, Ohio, Stany Zjednoczone, 43222
        • Mount Carmel Health - West Hospital
      • Columbus, Ohio, Stany Zjednoczone, 43215
        • CCOP - Columbus
      • Columbus, Ohio, Stany Zjednoczone, 43228
        • Doctors Hospital at Ohio Health
      • Columbus, Ohio, Stany Zjednoczone, 43215
        • Grant Riverside Cancer Services
      • Dayton, Ohio, Stany Zjednoczone, 45428
        • Veterans Affairs Medical Center - Dayton
      • Dayton, Ohio, Stany Zjednoczone, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Dayton, Ohio, Stany Zjednoczone, 45415
        • Samaritan North Cancer Care Center
      • Delaware, Ohio, Stany Zjednoczone, 43015
        • Grady Memorial Hospital
      • Findlay, Ohio, Stany Zjednoczone, 45840
        • Blanchard Valley Medical Associates
      • Fremont, Ohio, Stany Zjednoczone, 43420
        • Fremont Memorial Hospital
      • Kettering, Ohio, Stany Zjednoczone, 45429
        • Charles F. Kettering Memorial Hospital
      • Lancaster, Ohio, Stany Zjednoczone, 43130
        • Fairfield Medical Center
      • Lima, Ohio, Stany Zjednoczone, 45804
        • Lima Memorial Hospital
      • Lima, Ohio, Stany Zjednoczone, 45801
        • St. Rita's Medical Center
      • Mansfield, Ohio, Stany Zjednoczone, 44903
        • MedCentral - Mansfield Hospital
      • Marietta, Ohio, Stany Zjednoczone, 45750
        • Strecker Cancer Center at Marietta Memorial Hospital
      • Maumee, Ohio, Stany Zjednoczone, 43537
        • St. Luke's Hospital
      • Maumee, Ohio, Stany Zjednoczone, 43623
        • Northwest Ohio Oncology Center
      • Newark, Ohio, Stany Zjednoczone, 43055
        • Licking Memorial Cancer Care Program at Licking Memorial Hospital
      • Oregon, Ohio, Stany Zjednoczone, 43616
        • St. Charles Mercy Hospital
      • Sandusky, Ohio, Stany Zjednoczone, 44870
        • Firelands Regional Medical Center
      • Springfield, Ohio, Stany Zjednoczone, 45505
        • Community Hospital of Springfield and Clark County
      • Springfield, Ohio, Stany Zjednoczone, 45504
        • Mercy Medical Center
      • Sylvania, Ohio, Stany Zjednoczone, 43560
        • Flower Hospital Cancer Center
      • Tiffin, Ohio, Stany Zjednoczone, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, Stany Zjednoczone, 43608
        • St. Vincent Mercy Medical Center
      • Toledo, Ohio, Stany Zjednoczone, 43606
        • Toledo Hospital
      • Toledo, Ohio, Stany Zjednoczone, 43614
        • Medical University of Ohio Cancer Center
      • Toledo, Ohio, Stany Zjednoczone, 43623
        • Toledo Clinic, Incorporated - Main Clinic
      • Toledo, Ohio, Stany Zjednoczone, 43623
        • CCOP - Toledo Community Hospital
      • Troy, Ohio, Stany Zjednoczone, 45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Wauseon, Ohio, Stany Zjednoczone, 43567
        • Fulton County Health Center
    • Pennsylvania
      • Allentown, Pennsylvania, Stany Zjednoczone, 18105
        • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
      • Bryn Mawr, Pennsylvania, Stany Zjednoczone, 19010
        • Bryn Mawr Hospital
      • Danville, Pennsylvania, Stany Zjednoczone, 17822-0001
        • Geisinger Medical Center
      • Dubois, Pennsylvania, Stany Zjednoczone, 15801
        • Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center
      • Easton, Pennsylvania, Stany Zjednoczone, 18042
        • Easton Regional Cancer Center at Easton Hospital
      • Harrisburg, Pennsylvania, Stany Zjednoczone, 17105
        • PinnacleHealth Regional Cancer Center at Polyclinic Hospital
      • Hershey, Pennsylvania, Stany Zjednoczone, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Lancaster, Pennsylvania, Stany Zjednoczone, 17604
        • Lancaster General Hospital
      • Lewistown, Pennsylvania, Stany Zjednoczone, 17044
        • Lewistown Hospital
      • Paoli, Pennsylvania, Stany Zjednoczone, 19301-1792
        • Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19107
        • Joan Karnell Cancer Center at Pennsylvania Hospital
      • Phoenixville, Pennsylvania, Stany Zjednoczone, 19460
        • Cancer Center at Phoenixville Hospital
      • Pittsburgh, Pennsylvania, Stany Zjednoczone, 15212
        • Allegheny Cancer Center at Allegheny General Hospital
      • Pittsburgh, Pennsylvania, Stany Zjednoczone, 15232
        • Hillman Cancer Center at University of Pittsburgh Cancer Institute
      • Pottstown, Pennsylvania, Stany Zjednoczone, 19464
        • Pottstown Memorial Regional Cancer Center
      • Reading, Pennsylvania, Stany Zjednoczone, 19612-6052
        • Reading Hospital and Medical Center
      • Scranton, Pennsylvania, Stany Zjednoczone, 18501
        • Mercy Hospital Cancer Center - Scranton
      • Scranton, Pennsylvania, Stany Zjednoczone, 18510
        • Hematology and Oncology Associates
      • Sellersville, Pennsylvania, Stany Zjednoczone, 18960
        • Grand View Hospital
      • State College, Pennsylvania, Stany Zjednoczone, 16803
        • Mount Nittany Medical Center
      • West Grove, Pennsylvania, Stany Zjednoczone, 19390-9499
        • Jennersville Regional Hospital
      • Wilkes-Barre, Pennsylvania, Stany Zjednoczone, 18711
        • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
      • Wynnewood, Pennsylvania, Stany Zjednoczone, 19096
        • CCOP - MainLine Health
      • Wynnewood, Pennsylvania, Stany Zjednoczone, 19096
        • Lankenau Cancer Center at Lankenau Hospital
    • South Carolina
      • Aiken, South Carolina, Stany Zjednoczone, 29801
        • Cancer Care Institute of Carolina at Aiken Regional Medical Centers
      • Greenville, South Carolina, Stany Zjednoczone, 29615
        • CCOP - Greenville
    • South Dakota
      • Sioux Falls, South Dakota, Stany Zjednoczone, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, Stany Zjednoczone, 57117-5039
        • Sioux Valley Hospital and University of South Dakota Medical Center
      • Sioux Falls, South Dakota, Stany Zjednoczone, 57105
        • Medical X-Ray Center, PC
    • Tennessee
      • Kingsport, Tennessee, Stany Zjednoczone, 37662
        • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
      • Nashville, Tennessee, Stany Zjednoczone, 37208-3599
        • MBCCOP - Meharry Medical College - Nashville
    • Texas
      • Temple, Texas, Stany Zjednoczone, 76508
        • CCOP - Scott and White Hospital
    • Virginia
      • Charlottesville, Virginia, Stany Zjednoczone, 22908
        • University of Virginia Cancer Center at UV Health System
      • Danville, Virginia, Stany Zjednoczone, 24541
        • Danville Regional Medical Center
      • Norton, Virginia, Stany Zjednoczone, 24273
        • Southwest Virginia Regional Cancer Center
      • Richmond, Virginia, Stany Zjednoczone, 23298-0037
        • Virginia Commonwealth University Massey Cancer Center
    • West Virginia
      • Charleston, West Virginia, Stany Zjednoczone, 25304
        • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
      • Huntington, West Virginia, Stany Zjednoczone, 25701
        • Marshall University Medical Center
    • Wisconsin
      • Green Bay, Wisconsin, Stany Zjednoczone, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, Stany Zjednoczone, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, Stany Zjednoczone, 54303
        • St. Mary's Hospital Medical Center - Green Bay
      • Green Bay, Wisconsin, Stany Zjednoczone, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital
      • La Crosse, Wisconsin, Stany Zjednoczone, 54601
        • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
      • Madison, Wisconsin, Stany Zjednoczone, 53792-6164
        • University of Wisconsin Comprehensive Cancer Center
      • Madison, Wisconsin, Stany Zjednoczone, 53717
        • Dean Medical Center - Madison
      • Marinette, Wisconsin, Stany Zjednoczone, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Marshfield, Wisconsin, Stany Zjednoczone, 54449
        • Marshfield Clinic - Marshfield Center
      • Oconto Falls, Wisconsin, Stany Zjednoczone, 54154
        • Green Bay Oncology, Limited - Oconto Falls
      • Racine, Wisconsin, Stany Zjednoczone, 53405
        • All Saints Cancer Center at All Saints Healthcare
      • Sturgeon Bay, Wisconsin, Stany Zjednoczone, 54235
        • Green Bay Oncology, Limited - Sturgeon Bay

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny 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
Lek: carboplatin
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
Inne nazwy:
  • CBDCA
  • JM-8
  • Paraplatyna
  • NSC 241240
Lek: paclitaxel
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
Inne nazwy:
  • Taksol
  • NSC 125973
Promieniowanie: radiation therapy
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
Inne nazwy:
  • thoracic radiotherapy
Eksperymentalny: 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.
Lek: carboplatin
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
Inne nazwy:
  • CBDCA
  • JM-8
  • Paraplatyna
  • NSC 241240
Lek: paclitaxel
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
Inne nazwy:
  • Taksol
  • NSC 125973
Promieniowanie: radiation therapy
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
Inne nazwy:
  • thoracic radiotherapy
Lek: 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.
Inne nazwy:
  • Talomid
  • (d,1)-N phthalidoglutarimide
  • NSC #66847
  • IND # 48832

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Overall Survival Time
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Time to Disease Progression
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

National Cancer Institute (NCI)

Śledczy

  • Krzesło do nauki: Joan H. Schiller, MD, Simmons Cancer Center

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 stycznia 2000

Zakończenie podstawowe (Rzeczywisty)

1 grudnia 2009

Ukończenie studiów (Rzeczywisty)

1 marca 2010

Daty rejestracji na studia

Pierwszy przesłany

7 marca 2000

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 stycznia 2003

Pierwszy wysłany (Oszacować)

27 stycznia 2003

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

2 czerwca 2014

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 maja 2014

Ostatnia weryfikacja

1 lutego 2013

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • NCI-2012-02943
  • U10CA021115 (Grant/umowa NIH USA)
  • E3598 (Inny identyfikator: Eastern Cooperative Oncology Group (ECOG))
  • CDR0000067510 (Identyfikator rejestru: PDQ (Physician Data Query))

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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