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

29 mei 2014 bijgewerkt door: 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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

589

Fase

  • Fase 3

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Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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
Geneesmiddel: 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
Andere namen:
  • CBDCA
  • JM-8
  • Paraplatine
  • NSC 241240
Geneesmiddel: 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
Andere namen:
  • Taxol
  • NSC 125973
Straling: 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
Andere namen:
  • thoracic radiotherapy
Experimenteel: 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.
Geneesmiddel: 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
Andere namen:
  • CBDCA
  • JM-8
  • Paraplatine
  • NSC 241240
Geneesmiddel: 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
Andere namen:
  • Taxol
  • NSC 125973
Straling: 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
Andere namen:
  • thoracic radiotherapy
Geneesmiddel: 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.
Andere namen:
  • Thalomide
  • (d,1)-N phthalidoglutarimide
  • NSC #66847
  • IND # 48832

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Survival Time
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to Disease Progression
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Cancer Institute (NCI)

Onderzoekers

  • Studie stoel: Joan H. Schiller, MD, Simmons Cancer Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2000

Primaire voltooiing (Werkelijk)

1 december 2009

Studie voltooiing (Werkelijk)

1 maart 2010

Studieregistratiedata

Eerst ingediend

7 maart 2000

Eerst ingediend dat voldeed aan de QC-criteria

26 januari 2003

Eerst geplaatst (Schatting)

27 januari 2003

Updates van studierecords

Laatste update geplaatst (Schatting)

2 juni 2014

Laatste update ingediend die voldeed aan QC-criteria

29 mei 2014

Laatst geverifieerd

1 februari 2013

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NCI-2012-02943
  • U10CA021115 (Subsidie/contract van de Amerikaanse NIH)
  • E3598 (Andere identificatie: Eastern Cooperative Oncology Group (ECOG))
  • CDR0000067510 (Register-ID: PDQ (Physician Data Query))

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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