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

2014年5月29日更新者：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.

研究概览

地位

终止

条件

肺癌

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

589

阶段

第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
有源比较器：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	药品：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 其他名称： CBDCA JM-8 副铂国家安全委员会 241240 药品：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 其他名称：紫杉醇国家安全委员会 125973 辐射：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 其他名称： thoracic radiotherapy
实验性的：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.	药品：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 其他名称： CBDCA JM-8 副铂国家安全委员会 241240 药品：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 其他名称：紫杉醇国家安全委员会 125973 辐射：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 其他名称： thoracic radiotherapy 药品：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. 其他名称：沙洛米 (d,1)-N phthalidoglutarimide NSC #66847 IND # 48832

参与者组/臂

干预/治疗

有源比较器：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

药品：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

其他名称：

CBDCA
JM-8
副铂
国家安全委员会 241240

药品：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

其他名称：

紫杉醇
国家安全委员会 125973

辐射：radiation therapy

其他名称：

thoracic radiotherapy

实验性的：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.

药品：carboplatin

其他名称：

CBDCA
JM-8
副铂
国家安全委员会 241240

药品：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

其他名称：

紫杉醇
国家安全委员会 125973

辐射：radiation therapy

其他名称：

thoracic radiotherapy

药品：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.

其他名称：

沙洛米
(d,1)-N phthalidoglutarimide
NSC #66847
IND # 48832

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Overall Survival Time 大体时间：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

次要结果测量

结果测量	措施说明	大体时间
Time to Disease Progression 大体时间：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 大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National Cancer Institute (NCI)

调查人员

学习椅：Joan H. Schiller, MD、Simmons Cancer Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2000年1月1日

初级完成 (实际的)

2009年12月1日

研究完成 (实际的)

2010年3月1日

研究注册日期

首次提交

2000年3月7日

首先提交符合 QC 标准的

2003年1月26日

首次发布 (估计)

2003年1月27日

研究记录更新

最后更新发布 (估计)

2014年6月2日

上次提交的符合 QC 标准的更新

2014年5月29日

最后验证

2013年2月1日

carboplatin的临床试验

IO Biotech
Merck Sharp & Dohme LLC

完全的

IO102 联合派姆单抗，联合或不联合化疗，作为转移性非小细胞肺癌的一线治疗

非小细胞肺癌

英国, 德国, 荷兰, 西班牙
Virginia Commonwealth University
National Cancer Institute (NCI)

撤销

Phase I IGART Study Using Active Breathing Control and Simultaneous Boost for Patients With NSCLC

IIIA期非小细胞肺癌 | IIIB 期非小细胞肺癌 | 鳞状细胞肺癌 | 肺腺癌 | 大细胞肺癌 | IIA期非小细胞肺癌 | IIB 期非小细胞肺癌
Children's Oncology Group
National Cancer Institute (NCI)

完全的

接受室管膜瘤手术的儿童的观察或放射治疗和/或化疗和二次手术

脑肿瘤 | 中枢神经系统肿瘤

美国, 加拿大, 澳大利亚, 瑞士, 荷兰, 新西兰

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)

研究概览

地位

条件

干预/治疗

详细说明

研究类型

注册 (实际的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

有资格学习的性别

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

调查人员

出版物和有用的链接

一般刊物

研究记录日期

研究主要日期

学习开始

初级完成 (实际的)

研究完成 (实际的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (估计)

研究记录更新

最后更新发布 (估计)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

carboplatin的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Poland

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点