Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Patients With Stage III Non-small Cell Lung Cancer
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)
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Arkansas
-
Ft. Smith、Arkansas、アメリカ、72903
- Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
-
-
California
-
Modesto、California、アメリカ、95355
- Memorial Medical Center Cancer Services
-
Salinas、California、アメリカ、93901
- Salinas Valley Memorial Hospital
-
Stanford、California、アメリカ、94305
- Stanford Comprehensive Cancer Center at Stanford University Medical Center
-
-
Colorado
-
Aurora、Colorado、アメリカ、80012
- Aurora Presbyterian Hospital
-
Boulder、Colorado、アメリカ、80301-9019
- Boulder Community Hospital
-
Colorado Springs、Colorado、アメリカ、80933
- Penrose Cancer Center at Penrose Hospital
-
Colorado Springs、Colorado、アメリカ、80909
- Memorial Hospital
-
Denver、Colorado、アメリカ、80210
- Porter Adventist Hospital
-
Denver、Colorado、アメリカ、80220
- Rose Medical Center
-
Denver、Colorado、アメリカ、80218
- Presbyterian - St. Luke's Medical Center
-
Denver、Colorado、アメリカ、80218
- St. Joseph Hospital
-
Denver、Colorado、アメリカ、80224-2522
- CCOP - Colorado Cancer Research Program, Incorporated
-
Englewood、Colorado、アメリカ、80110
- Swedish Medical Center
-
Grand Junction、Colorado、アメリカ、81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
-
Lone Tree、Colorado、アメリカ、80124
- Sky Ridge Medical Center
-
Longmont、Colorado、アメリカ、80502
- Hope Cancer Care Center at Longmont United Hospital
-
Pueblo、Colorado、アメリカ、81004
- St. Mary-Corwin Regional Medical Center
-
Thornton、Colorado、アメリカ、80229
- North Suburban Medical Center
-
-
Connecticut
-
Danbury、Connecticut、アメリカ、06810
- Praxair Cancer Center at Danbury Hospital
-
Norwich、Connecticut、アメリカ、06360
- William W. Backus Hospital
-
-
Florida
-
Daytona Beach、Florida、アメリカ、32115
- Halifax Medical Center - Daytona Beach
-
Jacksonville、Florida、アメリカ、32207
- Baptist Cancer Institute - Jacksonville
-
-
Georgia
-
Augusta、Georgia、アメリカ、30912
- MBCCOP - Medical College of Georgia Cancer Center
-
Augusta、Georgia、アメリカ、30904
- Veterans Affairs Medical Center - Augusta
-
Decatur、Georgia、アメリカ、30033
- Veterans Affairs Medical Center - Atlanta (Decatur)
-
Macon、Georgia、アメリカ、31208
- Medical Center of Central Georgia
-
Savannah、Georgia、アメリカ、31403-3089
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
-
Valdosta、Georgia、アメリカ、31603
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
-
-
Illinois
-
Chicago、Illinois、アメリカ、60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
-
Chicago、Illinois、アメリカ、60625
- Swedish Covenant Hospital
-
Chicago、Illinois、アメリカ、60616
- Mercy Hospital and Medical Center
-
Hinsdale、Illinois、アメリカ、60521
- Hinsdale Hematology Oncology Associates
-
Joliet、Illinois、アメリカ、60432
- Midwest Center for Hematology/Oncology
-
Moline、Illinois、アメリカ、61265
- Trinity Medical Center - East
-
Rockford、Illinois、アメリカ、61104-2315
- Swedish-American Regional Cancer Center
-
Skokie、Illinois、アメリカ、60076
- Hematology/Oncology of the North Shore at Gross Point Medical Center
-
-
Indiana
-
Elkhart、Indiana、アメリカ、46515
- Elkhart General Hospital
-
Kokomo、Indiana、アメリカ、46904
- Howard Community Hospital at Howard Regional Health System
-
La Porte、Indiana、アメリカ、46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
-
Richmond、Indiana、アメリカ、47374
- Reid Hospital & Health Care Services, Incorporated
-
South Bend、Indiana、アメリカ、46601
- Memorial Hospital of South Bend
-
South Bend、Indiana、アメリカ、46601
- CCOP - Northern Indiana CR Consortium
-
South Bend、Indiana、アメリカ、46617
- Saint Joseph Regional Medical Center
-
-
Iowa
-
Bettendorf、Iowa、アメリカ、52722
- Hematology Oncology Associates of the Quad Cities
-
Cedar Rapids、Iowa、アメリカ、52402
- St. Luke's Hospital
-
Cedar Rapids、Iowa、アメリカ、52403
- Cedar Rapids Oncology Associates
-
Cedar Rapids、Iowa、アメリカ、52403
- Mercy Regional Cancer Center at Mercy Medical Center
-
Davenport、Iowa、アメリカ、52803
- Genesis Regional Cancer Center at Genesis Medical Center
-
Des Moines、Iowa、アメリカ、50309
- CCOP - Iowa Oncology Research Association
-
Des Moines、Iowa、アメリカ、50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
-
Des Moines、Iowa、アメリカ、50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
-
Des Moines、Iowa、アメリカ、50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
-
Des Moines、Iowa、アメリカ、50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
-
Des Moines、Iowa、アメリカ、50307
- Mercy Capitol Hospital
-
Des Moines、Iowa、アメリカ、50316-2301
- John Stoddard Cancer Center at Iowa Lutheran Hospital
-
Sioux City、Iowa、アメリカ、51101
- Siouxland Hematology-Oncology Associates, LLP
-
Sioux City、Iowa、アメリカ、51104
- St. Luke's Regional Medical Center
-
Sioux City、Iowa、アメリカ、51104
- Mercy Medical Center - Sioux City
-
West Des Moines、Iowa、アメリカ、50266
- Medical Oncology and Hematology Associates - West Des Moines
-
-
Kentucky
-
Madisonville、Kentucky、アメリカ、42431
- Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
-
-
Maryland
-
Annapolis、Maryland、アメリカ、21401
- DeCesaris Cancer Institute at Anne Arundel Medical Center
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02111
- Tufts-NEMC Cancer Center
-
Newton、Massachusetts、アメリカ、02462
- Newton-Wellesley Hospital
-
Springfield、Massachusetts、アメリカ、01199
- Baystate Regional Cancer Program at D'Amour Center for Cancer Care
-
Taunton、Massachusetts、アメリカ、02780
- Morton Hospital & Medical Center
-
-
Michigan
-
Adrian、Michigan、アメリカ、49221
- Hickman Cancer Center at Bixby Medical Center
-
Ann Arbor、Michigan、アメリカ、48106
- CCOP - Michigan Cancer Research Consortium
-
Ann Arbor、Michigan、アメリカ、48106-0995
- St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
-
Dearborn、Michigan、アメリカ、48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
-
Escanaba、Michigan、アメリカ、49431
- Green Bay Oncology, Limited - Escanaba
-
Flint、Michigan、アメリカ、48503
- Hurley Medical Center
-
Flint、Michigan、アメリカ、48503
- Genesys Hurley Cancer Institute
-
Grosse Pointe Woods、Michigan、アメリカ、48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
-
Iron Mountain、Michigan、アメリカ、49801
- Green Bay Oncology, Limited - Iron Mountain
-
Jackson、Michigan、アメリカ、49201
- Foote Hospital
-
Kalamazoo、Michigan、アメリカ、49007
- Bronson Methodist Hospital
-
Kalamazoo、Michigan、アメリカ、49007-3731
- West Michigan Cancer Center
-
Kalamazooaa、Michigan、アメリカ、49001
- Borgess Medical Center
-
Lambertville、Michigan、アメリカ、48144
- Haematology-Oncology Associates of Ohio and Michigan, PC
-
Lansing、Michigan、アメリカ、48909
- Sparrow Regional Cancer Center
-
Monroe、Michigan、アメリカ、48162
- Mercy Memorial Hospital System
-
Saginaw、Michigan、アメリカ、48601
- Seton Cancer Institute - Saginaw
-
St. Joseph、Michigan、アメリカ、49085
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
-
Warren、Michigan、アメリカ、48093
- St. John Macomb Hospital
-
-
Minnesota
-
Burnsville、Minnesota、アメリカ、55337
- Fairview Ridges Hospital
-
Coon Rapids、Minnesota、アメリカ、55433
- Mercy and Unity Cancer Center at Mercy Hospital
-
Duluth、Minnesota、アメリカ、55805
- CCOP - Duluth
-
Duluth、Minnesota、アメリカ、55805
- St. Mary's - Duluth Clinic Cancer Center
-
Duluth、Minnesota、アメリカ、55805
- Miller-Dwan Medical Center
-
Edina、Minnesota、アメリカ、55435
- Fairview Southdale Hospital
-
Fergus Falls、Minnesota、アメリカ、56537
-
Fridley、Minnesota、アメリカ、55432
- Mercy and Unity Cancer Center at Unity Hospital
-
Hutchinson、Minnesota、アメリカ、55350
- Hutchinson Area Health Care
-
Lichfield、Minnesota、アメリカ、55355
- Meeker County Memorial Hospital
-
Maplewood、Minnesota、アメリカ、55109
- HealthEast Cancer Care at St. John's Hospital
-
Minneapolis、Minnesota、アメリカ、55415
- Hennepin County Medical Center - Minneapolis
-
Minneapolis、Minnesota、アメリカ、55407
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
-
Robbinsdale、Minnesota、アメリカ、55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
-
Saint Louis Park、Minnesota、アメリカ、55416
- CCOP - Metro-Minnesota
-
Shakopee、Minnesota、アメリカ、55379
- Saint Francis Cancer Center
-
St Paul、Minnesota、アメリカ、55102
- St. Joseph's Hospital
-
St. Cloud、Minnesota、アメリカ、56303
- CentraCare Clinic - River Campus
-
St. Louis Park、Minnesota、アメリカ、55416
- Park Nicollet Health Services
-
St. Paul、Minnesota、アメリカ、55102
- United Hospital
-
St. Paul、Minnesota、アメリカ、55101
- Regions Hospital Cancer Care Center
-
Waconia、Minnesota、アメリカ、55387
- Ridgeview Medical Center
-
Woodbury、Minnesota、アメリカ、55125
- Woodwinds Health Campus
-
-
Missouri
-
Kansas City、Missouri、アメリカ、64131
- CCOP - Kansas City
-
Springfield、Missouri、アメリカ、65804
- St. John's Regional Health Center
-
Springfield、Missouri、アメリカ、65807
- Hulston Cancer Center at Cox Medical Center South
-
St. Louis、Missouri、アメリカ、63131
- Missouri Baptist Cancer Center
-
-
Montana
-
Billings、Montana、アメリカ、59101
- CCOP - Montana Cancer Consortium
-
Billings、Montana、アメリカ、59101
- Northern Rockies Radiation Oncology Center
-
Billings、Montana、アメリカ、59107-7000
- Deaconess Billings Clinic - Downtown
-
Great Falls、Montana、アメリカ、59405
- Great Falls Clinic
-
Great Falls、Montana、アメリカ、59405
-
Great Falls、Montana、アメリカ、59405
- Big Sky Oncology
-
Great Falls、Montana、アメリカ、59405
- Sletten Regional Cancer Institute at Benefis Healthcare
-
-
Nebraska
-
Lincoln、Nebraska、アメリカ、68510
- Cancer Resource Center - Lincoln
-
Omaha、Nebraska、アメリカ、68106
- CCOP - Missouri Valley Cancer Consortium
-
Omaha、Nebraska、アメリカ、68122
- Immanuel Medical Center
-
Omaha、Nebraska、アメリカ、68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
-
Omaha、Nebraska、アメリカ、68131-2197
- Creighton University Medical Center
-
-
Nevada
-
Las Vegas、Nevada、アメリカ、89106
- CCOP - Nevada Cancer Research Foundation
-
-
New Jersey
-
East Orange、New Jersey、アメリカ、07018-1095
- Veterans Affairs Medical Center - East Orange
-
Flemington、New Jersey、アメリカ、08822
- Hunterdon Regional Cancer Center at Hunterdon Medical Center
-
Hamilton、New Jersey、アメリカ、08690
- Cancer Institute of New Jersey at Hamilton
-
Marlton、New Jersey、アメリカ、08053
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
-
Montclair、New Jersey、アメリカ、07042
- Mountainside Hospital Cancer Center
-
Morristown、New Jersey、アメリカ、07962
- Carol G. Simon Cancer Center at Morristown Memorial Hospital
-
New Brunswick、New Jersey、アメリカ、08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
-
Phillipsburg、New Jersey、アメリカ、08865
- Warren Hospital
-
Red Bank、New Jersey、アメリカ、07701
- Booker Cancer Center at Riverview Medical Center
-
Somers Point、New Jersey、アメリカ、08244
- Shore Memorial Hospital - Somers Point
-
Summit、New Jersey、アメリカ、07902
- Overlook Hospital
-
Voorhees、New Jersey、アメリカ、08043
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
-
-
New York
-
Bronx、New York、アメリカ、10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
-
Bronx、New York、アメリカ、10466
- Our Lady of Mercy Medical Center Comprehensive Cancer Center
-
Buffalo、New York、アメリカ、14215
- Veterans Affairs Medical Center - Buffalo
-
Rochester、New York、アメリカ、14621
- Lipson Cancer and Blood Center at Rochester General Hospital
-
Syracuse、New York、アメリカ、13057
- CCOP - Hematology-Oncology Associates of Central New York
-
-
North Carolina
-
Goldsboro、North Carolina、アメリカ、27534
- Wayne Memorial Hospital, Incorporated
-
Wilson、North Carolina、アメリカ、27893-3428
- Wilson Medical Center
-
-
North Dakota
-
Bismarck、North Dakota、アメリカ、58501
- Bismarck Cancer Center
-
Bismarck、North Dakota、アメリカ、58501
- Cancer Care Center at Medcenter One Hospital
-
Bismarck、North Dakota、アメリカ、58501
- Mid Dakota Clinic, P. C.
-
Bismarck、North Dakota、アメリカ、58502
- St. Alexius Medical Center
-
-
Ohio
-
Akron、Ohio、アメリカ、44309-2090
- Akron City Hospital
-
Canton、Ohio、アメリカ、44710-1799
- Aultman Hospital Cancer Center at Aultman Health Foundation
-
Chillicothe、Ohio、アメリカ、45601
- Adena Regional Medical Center
-
Cleveland、Ohio、アメリカ、44109
- MetroHealth's Cancer Care Center at MetroHealth Medical Center
-
Columbus、Ohio、アメリカ、43214-3998
- Riverside Methodist Hospital Cancer Care
-
Columbus、Ohio、アメリカ、43222
- Mount Carmel Health - West Hospital
-
Columbus、Ohio、アメリカ、43215
- CCOP - Columbus
-
Columbus、Ohio、アメリカ、43228
- Doctors Hospital at Ohio Health
-
Columbus、Ohio、アメリカ、43215
- Grant Riverside Cancer Services
-
Dayton、Ohio、アメリカ、45428
- Veterans Affairs Medical Center - Dayton
-
Dayton、Ohio、アメリカ、45409
- David L. Rike Cancer Center at Miami Valley Hospital
-
Dayton、Ohio、アメリカ、45415
- Samaritan North Cancer Care Center
-
Delaware、Ohio、アメリカ、43015
- Grady Memorial Hospital
-
Findlay、Ohio、アメリカ、45840
- Blanchard Valley Medical Associates
-
Fremont、Ohio、アメリカ、43420
- Fremont Memorial Hospital
-
Kettering、Ohio、アメリカ、45429
- Charles F. Kettering Memorial Hospital
-
Lancaster、Ohio、アメリカ、43130
- Fairfield Medical Center
-
Lima、Ohio、アメリカ、45804
- Lima Memorial Hospital
-
Lima、Ohio、アメリカ、45801
- St. Rita's Medical Center
-
Mansfield、Ohio、アメリカ、44903
- MedCentral - Mansfield Hospital
-
Marietta、Ohio、アメリカ、45750
- Strecker Cancer Center at Marietta Memorial Hospital
-
Maumee、Ohio、アメリカ、43537
- St. Luke's Hospital
-
Maumee、Ohio、アメリカ、43623
- Northwest Ohio Oncology Center
-
Newark、Ohio、アメリカ、43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
-
Oregon、Ohio、アメリカ、43616
- St. Charles Mercy Hospital
-
Sandusky、Ohio、アメリカ、44870
- Firelands Regional Medical Center
-
Springfield、Ohio、アメリカ、45505
- Community Hospital of Springfield and Clark County
-
Springfield、Ohio、アメリカ、45504
- Mercy Medical Center
-
Sylvania、Ohio、アメリカ、43560
- Flower Hospital Cancer Center
-
Tiffin、Ohio、アメリカ、44883
- Mercy Hospital of Tiffin
-
Toledo、Ohio、アメリカ、43608
- St. Vincent Mercy Medical Center
-
Toledo、Ohio、アメリカ、43606
- Toledo Hospital
-
Toledo、Ohio、アメリカ、43614
- Medical University of Ohio Cancer Center
-
Toledo、Ohio、アメリカ、43623
- Toledo Clinic, Incorporated - Main Clinic
-
Toledo、Ohio、アメリカ、43623
- CCOP - Toledo Community Hospital
-
Troy、Ohio、アメリカ、45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Wauseon、Ohio、アメリカ、43567
- Fulton County Health Center
-
-
Pennsylvania
-
Allentown、Pennsylvania、アメリカ、18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
-
Bryn Mawr、Pennsylvania、アメリカ、19010
- Bryn Mawr Hospital
-
Danville、Pennsylvania、アメリカ、17822-0001
- Geisinger Medical Center
-
Dubois、Pennsylvania、アメリカ、15801
- Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center
-
Easton、Pennsylvania、アメリカ、18042
- Easton Regional Cancer Center at Easton Hospital
-
Harrisburg、Pennsylvania、アメリカ、17105
- PinnacleHealth Regional Cancer Center at Polyclinic Hospital
-
Hershey、Pennsylvania、アメリカ、17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
-
Lancaster、Pennsylvania、アメリカ、17604
- Lancaster General Hospital
-
Lewistown、Pennsylvania、アメリカ、17044
- Lewistown Hospital
-
Paoli、Pennsylvania、アメリカ、19301-1792
- Paoli Memorial Hospital
-
Philadelphia、Pennsylvania、アメリカ、19107
- Joan Karnell Cancer Center at Pennsylvania Hospital
-
Phoenixville、Pennsylvania、アメリカ、19460
- Cancer Center at Phoenixville Hospital
-
Pittsburgh、Pennsylvania、アメリカ、15212
- Allegheny Cancer Center at Allegheny General Hospital
-
Pittsburgh、Pennsylvania、アメリカ、15232
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
-
Pottstown、Pennsylvania、アメリカ、19464
- Pottstown Memorial Regional Cancer Center
-
Reading、Pennsylvania、アメリカ、19612-6052
- Reading Hospital and Medical Center
-
Scranton、Pennsylvania、アメリカ、18501
- Mercy Hospital Cancer Center - Scranton
-
Scranton、Pennsylvania、アメリカ、18510
- Hematology and Oncology Associates
-
Sellersville、Pennsylvania、アメリカ、18960
- Grand View Hospital
-
State College、Pennsylvania、アメリカ、16803
- Mount Nittany Medical Center
-
West Grove、Pennsylvania、アメリカ、19390-9499
- Jennersville Regional Hospital
-
Wilkes-Barre、Pennsylvania、アメリカ、18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
-
Wynnewood、Pennsylvania、アメリカ、19096
- CCOP - MainLine Health
-
Wynnewood、Pennsylvania、アメリカ、19096
- Lankenau Cancer Center at Lankenau Hospital
-
-
South Carolina
-
Aiken、South Carolina、アメリカ、29801
- Cancer Care Institute of Carolina at Aiken Regional Medical Centers
-
Greenville、South Carolina、アメリカ、29615
- CCOP - Greenville
-
-
South Dakota
-
Sioux Falls、South Dakota、アメリカ、57105
- Avera Cancer Institute
-
Sioux Falls、South Dakota、アメリカ、57117-5039
- Sioux Valley Hospital and University of South Dakota Medical Center
-
Sioux Falls、South Dakota、アメリカ、57105
- Medical X-Ray Center, PC
-
-
Tennessee
-
Kingsport、Tennessee、アメリカ、37662
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
-
Nashville、Tennessee、アメリカ、37208-3599
- MBCCOP - Meharry Medical College - Nashville
-
-
Texas
-
Temple、Texas、アメリカ、76508
- CCOP - Scott and White Hospital
-
-
Virginia
-
Charlottesville、Virginia、アメリカ、22908
- University of Virginia Cancer Center at UV Health System
-
Danville、Virginia、アメリカ、24541
- Danville Regional Medical Center
-
Norton、Virginia、アメリカ、24273
- Southwest Virginia Regional Cancer Center
-
Richmond、Virginia、アメリカ、23298-0037
- Virginia Commonwealth University Massey Cancer Center
-
-
West Virginia
-
Charleston、West Virginia、アメリカ、25304
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
-
Huntington、West Virginia、アメリカ、25701
- Marshall University Medical Center
-
-
Wisconsin
-
Green Bay、Wisconsin、アメリカ、54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Green Bay、Wisconsin、アメリカ、54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay、Wisconsin、アメリカ、54303
- St. Mary's Hospital Medical Center - Green Bay
-
Green Bay、Wisconsin、アメリカ、54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital
-
La Crosse、Wisconsin、アメリカ、54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
-
Madison、Wisconsin、アメリカ、53792-6164
- University of Wisconsin Comprehensive Cancer Center
-
Madison、Wisconsin、アメリカ、53717
- Dean Medical Center - Madison
-
Marinette、Wisconsin、アメリカ、54143
- Bay Area Cancer Care Center at Bay Area Medical Center
-
Marshfield、Wisconsin、アメリカ、54449
- Marshfield Clinic - Marshfield Center
-
Oconto Falls、Wisconsin、アメリカ、54154
- Green Bay Oncology, Limited - Oconto Falls
-
Racine、Wisconsin、アメリカ、53405
- All Saints Cancer Center at All Saints Healthcare
-
Sturgeon Bay、Wisconsin、アメリカ、54235
- Green Bay Oncology, Limited - Sturgeon Bay
-
-
-
-
-
Pretoria、南アフリカ、0001
- Pretoria Academic Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ: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 |
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
他の名前:
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
他の名前:
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
他の名前:
|
実験的: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. |
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
他の名前:
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
他の名前:
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
他の名前:
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.
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Overall Survival Time
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Time to Disease Progression
時間枠: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
時間枠: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
|
協力者と研究者
捜査官
- スタディチェア:Joan H. Schiller, MD、Simmons Cancer Center
出版物と役立つリンク
一般刊行物
- Belinsky SA, Grimes MJ, Casas E, Stidley CA, Franklin WA, Bocklage TJ, Johnson DH, Schiller JH. Predicting gene promoter methylation in non-small-cell lung cancer by evaluating sputum and serum. Br J Cancer. 2007 Apr 23;96(8):1278-83. doi: 10.1038/sj.bjc.6603721. Epub 2007 Apr 3.
- Belinsky SA, Grimes M, Johnson D, et al.: Predicting gene promoter methylation in lung tumors through examination of sputum and serum. [Abstract] J Clin Oncol 24 (Suppl 18): A-7208, 416s, 2006.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NCI-2012-02943
- U10CA021115 (米国 NIH グラント/契約)
- E3598 (その他の識別子:Eastern Cooperative Oncology Group (ECOG))
- CDR0000067510 (レジストリ識別子:PDQ (Physician Data Query))
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
肺癌の臨床試験
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
carboplatinの臨床試験
-
Virginia Commonwealth UniversityNational Cancer Institute (NCI)引きこもったステージ IIIA 非小細胞肺がん | ステージ IIIB 非小細胞肺がん | 扁平上皮肺がん | 肺の腺癌 | 大細胞肺がん | ステージ IIA 非小細胞肺がん | ステージ IIB 非小細胞肺がん
-
Children's Oncology GroupNational Cancer Institute (NCI)完了脳腫瘍 | 中枢神経系腫瘍アメリカ, カナダ, オーストラリア, スイス, オランダ, ニュージーランド