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

29. mai 2014 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

589

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
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
Legemiddel: 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
Andre navn:
  • CBDCA
  • JM-8
  • Paraplatin
  • NSC 241240
Legemiddel: 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
Andre navn:
  • Taxol
  • NSC 125973
Stråling: 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
Andre navn:
  • thoracic radiotherapy
Eksperimentell: 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.
Legemiddel: 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
Andre navn:
  • CBDCA
  • JM-8
  • Paraplatin
  • NSC 241240
Legemiddel: 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
Andre navn:
  • Taxol
  • NSC 125973
Stråling: 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
Andre navn:
  • thoracic radiotherapy
Legemiddel: 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.
Andre navn:
  • Thalomid
  • (d,1)-N phthalidoglutarimide
  • NSC #66847
  • IND # 48832

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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
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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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
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
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
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Cancer Institute (NCI)

Etterforskere

  • Studiestol: Joan H. Schiller, MD, Simmons Cancer Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2000

Primær fullføring (Faktiske)

1. desember 2009

Studiet fullført (Faktiske)

1. mars 2010

Datoer for studieregistrering

Først innsendt

7. mars 2000

Først innsendt som oppfylte QC-kriteriene

26. januar 2003

Først lagt ut (Anslag)

27. januar 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

2. juni 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. mai 2014

Sist bekreftet

1. februar 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NCI-2012-02943
  • U10CA021115 (U.S. NIH-stipend/kontrakt)
  • E3598 (Annen identifikator: Eastern Cooperative Oncology Group (ECOG))
  • CDR0000067510 (Registeridentifikator: PDQ (Physician Data Query))

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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