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

29 maggio 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

589

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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
Droga: 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
Altri nomi:
  • CBDCA
  • JM-8
  • Paraplatino
  • NSC 241240
Droga: 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
Altri nomi:
  • Tassolo
  • NSC 125973
Radiazione: 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
Altri nomi:
  • thoracic radiotherapy
Sperimentale: 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.
Droga: 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
Altri nomi:
  • CBDCA
  • JM-8
  • Paraplatino
  • NSC 241240
Droga: 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
Altri nomi:
  • Tassolo
  • NSC 125973
Radiazione: 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
Altri nomi:
  • thoracic radiotherapy
Droga: 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.
Altri nomi:
  • Thalomid
  • (d,1)-N phthalidoglutarimide
  • NSC #66847
  • IND # 48832

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival Time
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to Disease Progression
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Cancer Institute (NCI)

Investigatori

  • Cattedra di studio: Joan H. Schiller, MD, Simmons Cancer Center

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2000

Completamento primario (Effettivo)

1 dicembre 2009

Completamento dello studio (Effettivo)

1 marzo 2010

Date di iscrizione allo studio

Primo inviato

7 marzo 2000

Primo inviato che soddisfa i criteri di controllo qualità

26 gennaio 2003

Primo Inserito (Stima)

27 gennaio 2003

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

2 giugno 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 maggio 2014

Ultimo verificato

1 febbraio 2013

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NCI-2012-02943
  • U10CA021115 (Sovvenzione/contratto NIH degli Stati Uniti)
  • E3598 (Altro identificatore: Eastern Cooperative Oncology Group (ECOG))
  • CDR0000067510 (Identificatore di registro: PDQ (Physician Data Query))

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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