Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

29 de mayo de 2014 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Actual)

589

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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
Otros nombres:
  • 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
Otros nombres:
  • Taxol
  • NSC 125973
Radiación: 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
Otros nombres:
  • thoracic radiotherapy
Experimental: 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
Otros nombres:
  • 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
Otros nombres:
  • Taxol
  • NSC 125973
Radiación: 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
Otros nombres:
  • 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.
Otros nombres:
  • Talomida
  • (d,1)-N phthalidoglutarimide
  • NSC #66847
  • IND # 48832

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival Time
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to Disease Progression
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

National Cancer Institute (NCI)

Investigadores

  • Silla de estudio: Joan H. Schiller, MD, Simmons Cancer Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2000

Finalización primaria (Actual)

1 de diciembre de 2009

Finalización del estudio (Actual)

1 de marzo de 2010

Fechas de registro del estudio

Enviado por primera vez

7 de marzo de 2000

Primero enviado que cumplió con los criterios de control de calidad

26 de enero de 2003

Publicado por primera vez (Estimar)

27 de enero de 2003

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

2 de junio de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

29 de mayo de 2014

Última verificación

1 de febrero de 2013

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NCI-2012-02943
  • U10CA021115 (Subvención/contrato del NIH de EE. UU.)
  • E3598 (Otro identificador: Eastern Cooperative Oncology Group (ECOG))
  • CDR0000067510 (Identificador de registro: PDQ (Physician Data Query))

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir