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S9900: Surgery With or Without Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer

2013年1月30日 更新者：Southwest Oncology Group

A Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Paclitaxel/Carboplatin in Clinical Stage IB (T2N0), II (T1-2N1, T3N0) and Selected IIIA (T3N1) Non-Small Cell Lung Cancer (NSCLC)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if surgery plus combination chemotherapy is more effective than surgery alone for non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have non-small cell lung cancer.

研究概览

地位

完全的

条件

干预/治疗

详细说明

OBJECTIVES:

  • Compare survival of patients with previously untreated stage IB, II, or selected IIIA non-small cell lung cancer after preoperative chemotherapy comprising paclitaxel and carboplatin plus surgery vs surgery alone.
  • Compare these regimens in terms of operative mortality and other toxic effects in these patients.
  • Evaluate the response rates (confirmed and unconfirmed) and toxic effects associated with combined paclitaxel and carboplatin in these patients.
  • Obtain samples for correlation of radiologic, pathologic, molecular, and biologic factors with the outcome in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to clinical stage (IB or IIA vs IIB or IIIA).

Patients are randomized to one of two treatment arms:

  • Arm I: Patients undergo thoracotomy. All accessible hilar (level 10) lymph nodes are dissected, and complete mediastinal lymph node sampling is performed.
  • Arm II: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks of course 3, patients undergo thoracotomy and lymph node dissection as in arm I.

Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually until year 10.

PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 4 years.

研究类型

介入性

注册 (实际的)

354

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

  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2N 4N2
        • Tom Baker Cancer Center - Calgary
      • Edmonton、Alberta、加拿大、T6G 1Z2
        • Cross Cancer Institute
    • New Brunswick
      • Moncton、New Brunswick、加拿大、E1C 8X3
        • Doctor Leon Richard Oncology Centre
      • Saint John、New Brunswick、加拿大、E2L 4L2
        • Saint John Regional Hospital
    • Newfoundland and Labrador
      • St. Johns、Newfoundland and Labrador、加拿大、A1B 3V6
        • Newfoundland Cancer Treatment and Research Foundation
    • Nova Scotia
      • Halifax、Nova Scotia、加拿大、B3H 1V7
        • Nova Scotia Cancer Centre
    • Ontario
      • Hamilton、Ontario、加拿大、L8V 5C2
        • Margaret and Charles Juravinski Cancer Centre
      • Kingston、Ontario、加拿大、K7L 5P9
        • Kingston Regional Cancer Centre
      • London、Ontario、加拿大、N6A 4L6
        • Cancer Care Ontario-London Regional Cancer Centre
      • Ottawa、Ontario、加拿大、K1H 1C4
        • Ottawa Regional Cancer Centre
      • Sudbury、Ontario、加拿大、P3E 5J1
        • Northeastern Ontario Regional Cancer Centre at Regional Hospital of Sudbury Regional Hospital
      • Thunder Bay、Ontario、加拿大、P7B 6V4
        • Northwestern Ontario Regional Cancer Care
      • Toronto、Ontario、加拿大、M4N 3M5
        • Toronto Sunnybrook Regional Cancer Centre
      • Toronto、Ontario、加拿大、M5G 2M9
        • Princess Margaret Hospital
    • Quebec
      • Fleurimont、Quebec、加拿大、J1H 5N4
        • CHUS-Hopital Fleurimont
      • Montreal、Quebec、加拿大、H2W 1S6
        • McGill University
      • Montreal、Quebec、加拿大、H2L 4MI
        • Centre Hospitalier de l'Université de Montréal
      • Quebec City、Quebec、加拿大、G1R 2J6
        • Centre Hospitalier Universitaire de Quebec
    • Saskatchewan
      • Regina、Saskatchewan、加拿大、S4T 7T1
        • Allan Blair Cancer Centre
      • Saskatoon、Saskatchewan、加拿大、S7N 4H4
        • Saskatoon Cancer Centre
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294-3300
        • University of Alabama at Birmingham Comprehensive Cancer Center
      • Huntsville、Alabama、美国、35801
        • Comprehensive Cancer Institute
      • Huntsville、Alabama、美国、35807
        • Huntsville Hospital
      • Mobile、Alabama、美国、36607
        • MBCCOP - Gulf Coast
      • Montgomery、Alabama、美国、36106-3657
        • Montgomery Cancer Center
      • Tuscaloosa、Alabama、美国、35401
        • DCH Cancer Treatment Center
      • Tuscaloosa、Alabama、美国、35401
        • Radiation Oncology Associates of West Alabama
    • Arizona
      • Phoenix、Arizona、美国、85013
        • Foundation for Cancer Research and Education
      • Scottsdale、Arizona、美国、85259-5404
        • CCOP - Mayo Clinic Scottsdale Oncology Program
    • California
      • Burbank、California、美国、91505
        • Providence Saint Joseph Medical Center - Burbank
      • Concord、California、美国、94524-4110
        • Mount Diablo Medical Center
      • Fresno、California、美国、93720
        • California Cancer Center
      • Fresno、California、美国、93720
        • Saint Agnes Cancer Center
      • Greenbrae、California、美国、94904
        • Sutter Health Western Division Cancer Research Group
      • Loma Linda、California、美国、92354
        • Loma Linda University Cancer Institute at Loma Linda University Medical Center
      • Long Beach、California、美国、90822
        • Veterans Affairs Medical Center - Long Beach
      • Los Angeles、California、美国、90033-0804
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Los Angeles、California、美国、90095-1714
        • Jonsson Comprehensive Cancer Center, UCLA
      • Oakland、California、美国、94609-3305
        • CCOP - Bay Area Tumor Institute
      • Pasadena、California、美国、91105
        • Huntington Cancer Center at Huntington Hospital
      • Pomona、California、美国、91767
        • Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
      • Sacramento、California、美国、95816
        • Radiation Oncology Centers - Sacramento
      • San Diego、California、美国、92134-3202
        • Naval Medical Center - San Diego
      • San Diego、California、美国、92101
        • Radiation Medical Group, Incorporated
      • San Francisco、California、美国、94115
        • UCSF Comprehensive Cancer Center
      • San Jose、California、美国、95128
        • O'Connor Hospital
      • Santa Rosa、California、美国、95403
        • CCOP - Santa Rosa Memorial Hospital
      • Stanford、California、美国、94305-5408
        • Stanford Cancer Center at Stanford University Medical Center
      • Torrance、California、美国、90505
        • Torrance Memorial Medical Center
      • Travis Air Force Base、California、美国、94535
        • David Grant Medical Center
    • Colorado
      • Colorado Springs、Colorado、美国、80909
        • Memorial Hospital Cancer Center
      • Denver、Colorado、美国、80010
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center
      • Denver、Colorado、美国、80224
        • CCOP - Colorado Cancer Research Program, Incorporated
      • Grand Junction、Colorado、美国、81502-1628
        • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
    • Connecticut
      • New Haven、Connecticut、美国、06511
        • Hospital of St. Raphael
      • New Haven、Connecticut、美国、06520-8040
        • Yale Comprehensive Cancer Center
    • Delaware
      • Newark、Delaware、美国、19713
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington、District of Columbia、美国、20016
        • Sibley Memorial Hospital
    • Florida
      • Daytona Beach、Florida、美国、32114
        • Halifax Medical Center
      • Fort Myers、Florida、美国、33901-8082
        • 21st Century Oncology - Fort Myers
      • Gainesville、Florida、美国、32610-0385
        • Shands Cancer Center at the University of Florida Health Science Center
      • Jacksonville、Florida、美国、32224
        • Mayo Clinic - Jacksonville
      • Jacksonville、Florida、美国、32207
        • Florida Radiation Oncology Group
      • Melbourne、Florida、美国、32901-3276
        • Holmes Regional Medical Center
      • Miami、Florida、美国、33176-2197
        • Baptist Hospital of Miami
      • Miami、Florida、美国、33136
        • University of Miami Sylvester Cancer Center
      • Miami Beach、Florida、美国、33140
        • CCOP - Mount Sinai Medical Center
      • Orlando、Florida、美国、32806-2134
        • MD Anderson Cancer Center Orlando
      • Panama City、Florida、美国、32405-4587
        • Gulf Coast Cancer Treatment Center
      • Panama City、Florida、美国、32401
        • Bay Medical Center
      • Sarasota、Florida、美国、34233
        • Sarasota Radiation and Medical Oncology Center
      • Tallahassee、Florida、美国、32308
        • Tallahassee Memorial Hospital
      • Tampa、Florida、美国、33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Atlanta、Georgia、美国、30322
        • Winship Cancer Institute of Emory University
      • Atlanta、Georgia、美国、30342-1701
        • CCOP - Atlanta Regional
      • Columbus、Georgia、美国、31901
        • Medical Center/John B. Amos Community Cancer Center
      • Decatur、Georgia、美国、30033
        • Veterans Affairs Medical Center - Atlanta (Decatur)
      • Rome、Georgia、美国、30165
        • Regional Radiation Oncology Center at Rome
    • Hawaii
      • Honolulu、Hawaii、美国、96813
        • MBCCOP - Hawaii
    • Illinois
      • Arlington Heights、Illinois、美国、60005
        • Northwest Community Hospital
      • Chicago、Illinois、美国、60611
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
      • Decatur、Illinois、美国、62526
        • CCOP - Central Illinois
      • Downers Grove、Illinois、美国、60515
        • Cancer Care Center at Advocate Good Samaritan Hospital
      • Harvey、Illinois、美国、60426
        • Ingalls Memorial Hospital
      • Maywood、Illinois、美国、60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
      • Park Ridge、Illinois、美国、60068
        • Lutheran General Cancer Care Center
      • Peoria、Illinois、美国、61636
        • Methodist Medical Center of Illinois
      • Peoria、Illinois、美国、61602
        • CCOP - Illinois Oncology Research Association
      • Peoria、Illinois、美国、61602
        • CCOP - Scott and White Hospital
      • Urbana、Illinois、美国、61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Anderson、Indiana、美国、46016
        • St. John's Cancer Center at St. John's Medical Center
      • Bloomington、Indiana、美国、47402
        • Bloomington Hospital
      • Indianapolis、Indiana、美国、46202-5289
        • Indiana University Cancer Center
      • Indianapolis、Indiana、美国、46202
        • Veterans Affairs Medical Center - Indianapolis (Roudebush)
      • Indianapolis、Indiana、美国、46206-1367
        • Methodist Cancer Center at Methodist Hospital
      • Indianapolis、Indiana、美国、46219
        • Community Regional Cancer Care
      • Muncie、Indiana、美国、47303-3499
        • Ball Memorial Hospital Cancer Center
      • South Bend、Indiana、美国、46601
        • CCOP - Northern Indiana CR Consortium
    • Iowa
      • Cedar Rapids、Iowa、美国、52403-1206
        • CCOP - Cedar Rapids Oncology Project
      • Des Moines、Iowa、美国、50309-1016
        • CCOP - Iowa Oncology Research Association
      • Dubuque、Iowa、美国、52001
        • Wendt Regional Cancer Center of Finley Hospital
      • Sioux City、Iowa、美国、51101-1733
        • Siouxland Hematology-Oncology
    • Kansas
      • Wichita、Kansas、美国、67214-3882
        • CCOP - Wichita
    • Kentucky
      • Edgewood、Kentucky、美国、41017
        • St. Elizabeth Medical Center
      • Lexington、Kentucky、美国、40503
        • Central Baptist Hospital
      • Lexington、Kentucky、美国、40536-0293
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
      • Louisville、Kentucky、美国、40202
        • James Graham Brown Cancer Center at University of Louisville
      • Louisville、Kentucky、美国、40215
        • Louisville Radiation Oncology Center at Caritas Regional Cancer Center
      • Madisonville、Kentucky、美国、42431
        • Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
    • Louisiana
      • Baton Rouge、Louisiana、美国、70809
        • Mary Bird Perkins Cancer Center
      • New Orleans、Louisiana、美国、70121
        • CCOP - Ochsner
      • New Orleans、Louisiana、美国、70112
        • MBCCOP - LSU Health Sciences Center
      • New Orleans、Louisiana、美国、70112-2699
        • Tulane Cancer Center at Tulane University Hospital and Clinic
    • Maine
      • Portland、Maine、美国、04102
        • Maine Medical Center
    • Maryland
      • Annapolis、Maryland、美国、21401
        • Anne Arundel Oncology Center
      • Baltimore、Maryland、美国、21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
      • Baltimore、Maryland、美国、21215
        • Sinai Hospital of Baltimore
      • Baltimore、Maryland、美国、21204
        • Greater Baltimore Medical Center and Cancer Center
      • Baltimore、Maryland、美国、21201
        • Greenebaum Cancer Center at University of Maryland Medical Center
      • Baltimore、Maryland、美国、21215-1290
        • Harbor Hospital Center
      • Baltimore、Maryland、美国、21229
        • St. Agnes Cancer Center
      • Salisbury、Maryland、美国、21801
        • Peninsula Regional Medical Center
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • Beth Israel Deaconess Medical Center
      • Boston、Massachusetts、美国、02118
        • Cancer Research Center at Boston Medical Center
      • Boston、Massachusetts、美国、02111
        • TUFTS - New England Medical Center
      • Boston、Massachusetts、美国、02114
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
      • Hyannis、Massachusetts、美国、02601
        • Cape Cod Hospital
      • Jamaica Plain、Massachusetts、美国、02130
        • Veterans Affairs Medical Center - Boston (Jamaica Plain)
      • Peabody、Massachusetts、美国、01960
        • NSMC Cancer Center
    • Michigan
      • Ann Arbor、Michigan、美国、48106
        • CCOP - Michigan Cancer Research Consortium
      • Ann Arbor、Michigan、美国、48109-0010
        • University of Michigan Comprehensive Cancer Center
      • Detroit、Michigan、美国、48201
        • Barbara Ann Karmanos Cancer Institute
      • Detroit、Michigan、美国、48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
      • Flint、Michigan、美国、48503
        • Hurley Medical Center
      • Flint、Michigan、美国、48532-3685
        • McLaren Regional Cancer Center
      • Kalamazoo、Michigan、美国、49007-3731
        • CCOP - Kalamazoo
      • Marquette、Michigan、美国、49855
        • Marquette General Hospital
      • Midland、Michigan、美国、48670
        • MidMichigan Medical Center - Midland
      • Royal Oak、Michigan、美国、48073
        • William Beaumont Hospital - Royal Oak
      • Royal Oak、Michigan、美国、48073-6769
        • CCOP - Beaumont
      • Troy、Michigan、美国、48085
        • William Beaumont Hospital - Troy
    • Minnesota
      • Duluth、Minnesota、美国、55805
        • CCOP - Duluth
      • Minneapolis、Minnesota、美国、55455
        • Fairview University Medical Center - University Campus
      • Minneapolis、Minnesota、美国、55417-2399
        • Veterans Affairs Medical Center - Minneapolis
      • Rochester、Minnesota、美国、55905-0001
        • Mayo Clinic Cancer Center
      • Saint Cloud、Minnesota、美国、56303
        • Coborn Cancer Center
      • Saint Louis Park、Minnesota、美国、55416
        • CCOP - Metro-Minnesota
    • Missouri
      • Columbia、Missouri、美国、65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Kansas City、Missouri、美国、64131
        • CCOP - Kansas City
      • Saint Louis、Missouri、美国、63110-0250
        • St. Louis University Hospital Cancer Center
      • Springfield、Missouri、美国、65807
        • CCOP - Cancer Research for the Ozarks
      • Springfield、Missouri、美国、65807
        • Cancer Research for the Ozarks
      • St. Louis、Missouri、美国、63110
        • Siteman Cancer Center
    • Montana
      • Billings、Montana、美国、59101
        • CCOP - Montana Cancer Consortium
    • Nebraska
      • Omaha、Nebraska、美国、68106
        • CCOP - Missouri Valley Cancer Consortium
      • Omaha、Nebraska、美国、68114-4199
        • Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
      • Omaha、Nebraska、美国、68198-7521
        • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
    • Nevada
      • Las Vegas、Nevada、美国、89106
        • CCOP - Southern Nevada Cancer Research Foundation
      • Las Vegas、Nevada、美国、89109
        • Comprehensive Cancer Centers of Nevada
    • New Hampshire
      • Lebanon、New Hampshire、美国、03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
      • Manchester、New Hampshire、美国、03103
        • Elliot Regional Cancer Center
    • New Jersey
      • East Orange、New Jersey、美国、07019
        • Veterans Affairs Medical Center - East Orange
      • Edison、New Jersey、美国、08818
        • John F. Kennedy Medical Center
      • Elizabeth、New Jersey、美国、07201
        • Trinitas Hospital - Jersey Street Campus
      • Long Branch、New Jersey、美国、07740-6395
        • Monmouth Medical Center
      • Millville、New Jersey、美国、08332
        • South Jersey Regional Cancer Center
      • Mount Holly、New Jersey、美国、08060
        • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
      • New Brunswick、New Jersey、美国、08903
        • Cancer Institute of New Jersey
      • Newark、New Jersey、美国、07112
        • Newark Beth Israel Medical Center
      • Pomona、New Jersey、美国、08240
        • Atlantic City Medical Center
      • Princeton、New Jersey、美国、08540
        • Medical Center of Princeton
      • Ridgewood、New Jersey、美国、07450
        • Valley Hospital
      • Toms River、New Jersey、美国、08755
        • Community Medical Center
      • Trenton、New Jersey、美国、08629
        • Fox Chase Cancer Center at St. Francis Medical Center
      • Warren、New Jersey、美国、07059
        • Associated Radiologists, P.A.
    • New Mexico
      • Albuquerque、New Mexico、美国、87109
        • Radiation Oncology Associates of Albuquerque
    • New York
      • Albany、New York、美国、12208
        • Cancer Center of Albany Medical Center
      • Bronx、New York、美国、10466
        • MBCCOP-Our Lady of Mercy Cancer Center
      • Brooklyn、New York、美国、11203
        • SUNY Downstate Medical Center
      • Brooklyn、New York、美国、11215
        • New York Methodist Hospital
      • Buffalo、New York、美国、14263-0001
        • Roswell Park Cancer Institute
      • Clifton Springs、New York、美国、14432
        • Finger Lakes Radiation Oncology Center
      • East Syracuse、New York、美国、13057
        • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
      • Manhasset、New York、美国、11030
        • CCOP - North Shore University Hospital
      • New York、New York、美国、10021
        • Memorial Sloan-Kettering Cancer Center
      • New York、New York、美国、10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University
      • New York、New York、美国、10003
        • Beth Israel Medical Center - Philipps Ambulatory Care Center
      • Plattsburgh、New York、美国、12901-1490
        • Champlain Valley Physicians Hospital Medical Center
      • Poughkeepsie、New York、美国、12601
        • Vassar Brothers Medical Center
      • Rochester、New York、美国、14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Yonkers、New York、美国、10701
        • Riverhill Radiation Oncology
    • North Carolina
      • Chapel Hill、North Carolina、美国、27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Concord、North Carolina、美国、28025
        • Batte Cancer Center at Northeast Medical Center
      • Greenville、North Carolina、美国、27835-6028
        • Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
      • Winston-Salem、North Carolina、美国、27104-4241
        • CCOP - Southeast Cancer Control Consortium
      • Winston-Salem、North Carolina、美国、27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • North Dakota
      • Bismarck、North Dakota、美国、58501-5505
        • Medcenter One Health System
      • Fargo、North Dakota、美国、58122
        • CCOP - Merit Care Hospital
      • Grand Forks、North Dakota、美国、58201
        • Altru Cancer Center
      • Minot、North Dakota、美国、58701
        • Trinity Cancer Care Center
    • Ohio
      • Akron、Ohio、美国、44302
        • Akron General Medical Center
      • Akron、Ohio、美国、44304
        • Akron City Hospital
      • Cincinnati、Ohio、美国、45219
        • Cancer Center at Christ Hospital
      • Cincinnati、Ohio、美国、45219
        • Charles M. Barrett Cancer Center at University Hospital
      • Cleveland、Ohio、美国、44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland、Ohio、美国、44106
        • University Hospitals of Cleveland
      • Cleveland、Ohio、美国、44106-5065
        • MetroHealth's Cancer Care Center at MetroHealth Medical Center
      • Columbus、Ohio、美国、43210-1240
        • Arthur G. James Cancer Hospital - Ohio State University
      • Columbus、Ohio、美国、43206
        • CCOP - Columbus
      • Dayton、Ohio、美国、45429
        • CCOP - Dayton
      • Parma、Ohio、美国、44129
        • Parma Community General Hospital
      • Toledo、Ohio、美国、43623-3456
        • CCOP - Toledo Community Hospital
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73104
        • Oklahoma University Medical Center
      • Oklahoma City、Oklahoma、美国、73102
        • Frank C. Love Cancer Institute at St. Anthony Hospital
      • Tulsa、Oklahoma、美国、74136
        • CCOP - Oklahoma
      • Tulsa、Oklahoma、美国、74104
        • St. John Health System
    • Oregon
      • Portland、Oregon、美国、97225
        • CCOP - Columbia River Oncology Program
    • Pennsylvania
      • Abington、Pennsylvania、美国、19001
        • Abington Memorial Hospital
      • Allentown、Pennsylvania、美国、18105
        • John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
      • Bethlehem、Pennsylvania、美国、18015
        • St. Luke's Hospital Cancer Center
      • Danville、Pennsylvania、美国、17822-2001
        • CCOP - Geisinger Clinic and Medical Center
      • Danville、Pennsylvania、美国、17822-2001
        • Geisinger Medical Center
      • Darby、Pennsylvania、美国、19023
        • Mercy Fitzgerald Hospital
      • Drexel Hill、Pennsylvania、美国、19026
        • Delaware County Memorial Hospital
      • East Stroudsburg、Pennsylvania、美国、18301
        • Dale and Frances Hughes Cancer Center
      • Hershey、Pennsylvania、美国、17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Philadelphia、Pennsylvania、美国、19111
        • Fox Chase Cancer Center
      • Philadelphia、Pennsylvania、美国、19104
        • Veterans Affairs Medical Center - Philadelphia
      • Philadelphia、Pennsylvania、美国、19107-5541
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Philadelphia、Pennsylvania、美国、19141-3098
        • Albert Einstein Cancer Center
      • Philadelphia、Pennsylvania、美国、19104
        • Abramson Cancer Center at University of Pennsylvania Medical Center
      • Pittsburgh、Pennsylvania、美国、15212
        • Allegheny General Hospital
      • Pittsburgh、Pennsylvania、美国、15224
        • Western Pennsylvania Hospital
      • Pittsburgh、Pennsylvania、美国、15219
        • Mercy Hospital of Pittsburgh
      • Pittsburgh、Pennsylvania、美国、15236
        • Hillman Cancer Center at University of Pittsburgh Cancer Institute
      • Reading、Pennsylvania、美国、19612-6052
        • Reading Hospital and Medical Center
      • Scranton、Pennsylvania、美国、18501
        • Mercy Hospital Cancer Center - Scranton
      • Wilkes-Barre、Pennsylvania、美国、18764-0001
        • Wilkes-Barre General Hospital
      • Wynnewood、Pennsylvania、美国、19096
        • CCOP - MainLine Health
      • York、Pennsylvania、美国、17403
        • Wellspan Health - York Cancer Center
    • Rhode Island
      • Providence、Rhode Island、美国、02908-4735
        • Roger Williams Medical Center
    • South Carolina
      • Greenville、South Carolina、美国、29615
        • CCOP - Greenville
      • Spartanburg、South Carolina、美国、29303
        • CCOP - Upstate Carolina
    • South Dakota
      • Rapid City、South Dakota、美国、57709
        • Rapid City Regional Hospital
      • Sioux Falls、South Dakota、美国、57104
        • CCOP - Sioux Community Cancer Consortium
    • Tennessee
      • Jackson、Tennessee、美国、38301
        • West Tennessee Cancer Center at Jackson-Madison County General Hospital
      • Nashville、Tennessee、美国、37232-5671
        • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
    • Texas
      • Amarillo、Texas、美国、79106
        • Harrington Cancer Center
      • Arlington、Texas、美国、76012
        • Arlington Cancer Center
      • Galveston、Texas、美国、77555-0209
        • University of Texas Medical Branch
      • Houston、Texas、美国、77030-4009
        • University of Texas - MD Anderson Cancer Center
      • Lackland Air Force Base、Texas、美国、78236-5300
        • Wilford Hall Medical Center
      • Lubbock、Texas、美国、79410-1894
        • Joe Arrington Cancer Research and Treatment Center
      • Pasadena、Texas、美国、77504
        • Bayshore Medical Center
      • San Antonio、Texas、美国、78284-7811
        • University of Texas Health Science Center at San Antonio
    • Utah
      • Murray、Utah、美国、84107
        • Cottonwood Hospital Medical Center
      • Provo、Utah、美国、84604
        • Utah Valley Regional Medical Center - Provo
      • Saint George、Utah、美国、84770
        • Dixie Regional Medical Center
      • Salt Lake City、Utah、美国、84132
        • University of Utah Health Sciences Center
      • Salt Lake City、Utah、美国、84143
        • LDS Hospital
    • Vermont
      • Bennington、Vermont、美国、05201
        • Green Mountain Oncology Group
      • Burlington、Vermont、美国、05405-0075
        • Vermont Cancer Center at University of Vermont
    • Virginia
      • Charlottesville、Virginia、美国、22908
        • Cancer Center at the University of Virginia
      • Harrisonburg、Virginia、美国、22801
        • RMH Regional Cancer Center
      • Portsmouth、Virginia、美国、23708-2197
        • Naval Medical Center, Portsmouth
      • Richmond、Virginia、美国、23226
        • Bon Secours - St. Mary's Hospital
      • Richmond、Virginia、美国、23298-0124
        • Massey Cancer Center at Virginia Commonwealth University
    • Washington
      • Seattle、Washington、美国、98195-6043
        • University Cancer Center at University of Washington Medical Center
      • Seattle、Washington、美国、98111
        • Cancer Institute at Virginia Mason Medical Center
      • Spokane、Washington、美国、99204
        • Deaconess Medical Center
      • Yakima、Washington、美国、98902
        • Yakima Valley Memorial Hospital
    • West Virginia
      • Wheeling、West Virginia、美国、26003
        • Schiffler Cancer Center at Wheeling Hospital
    • Wisconsin
      • Green Bay、Wisconsin、美国、54307-3508
        • St. Vincent Hospital
      • Green Bay、Wisconsin、美国、54307-3453
        • CCOP - St. Vincent Hospital Cancer Center, Green Bay
      • La Crosse、Wisconsin、美国、54601
        • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
      • Madison、Wisconsin、美国、53705
        • Veterans Affairs Medical Center - Madison
      • Madison、Wisconsin、美国、53713
        • Southern Wisconsin Radiotherapy Center
      • Madison、Wisconsin、美国、53792-0001
        • University of Wisconsin Comprehensive Cancer Center
      • Marshfield、Wisconsin、美国、54449
        • Marshfield Clinic
      • Marshfield、Wisconsin、美国、54449
        • CCOP - Marshfield Clinic Research Foundation
      • Menomonee Falls、Wisconsin、美国、53051
        • Community Memorial Hospital
      • Milwaukee、Wisconsin、美国、53211
        • Columbia Hospital
      • Milwaukee、Wisconsin、美国、53215
        • St. Luke's Medical Center
      • Milwaukee、Wisconsin、美国、53295
        • Veterans Affairs Medical Center - Milwaukee (Zablocki)
      • Milwaukee、Wisconsin、美国、53226
        • Medical College of Wisconsin Cancer Center
      • Racine、Wisconsin、美国、53405
        • All Saints Cancer Center at All Saints Healthcare
      • Waukesha、Wisconsin、美国、53188
        • Waukesha Memorial Hospital Regional Cancer Center

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically proven non-small cell lung cancer (NSCLC), meeting 1 of the following staging criteria:

    • Stage IB (T2, N0)

    • Stage II

      • T1-2, N1 with negative mediastinoscopy OR
      • T3, N0

    • Selected stage IIIA with negative mediastinoscopies

      • T3, N1, excluding superior sulcus
      • Positive level 10 hilar nodes allowed if mediastinoscopy negative
  • Apical tumors with no clinical symptoms allowed

  • No symptomatic tumors (T3, N0 or T3, N1) involving the superior sulcus

    • No Pancoast's tumors
  • Negative mediastinoscopy required in all patients with clinically positive mediastinal or hilar lymph nodes to ensure no N2 disease

  • Bidimensionally measurable or evaluable disease by chest x-ray or contrast-enhanced CT scan

    • T3, N0 disease assessable only by bronchoscopy must be affirmed by 2 observers and documented by photograph that includes main carina

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0 or 1

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • WBC at least 4,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT no greater than 2 times ULN
  • Alkaline phosphatase no greater than 2 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN
  • Creatinine clearance at least 50 mL/min

Pulmonary:

  • See Disease Characteristics
  • Preresection FEV_1 greater than 2.0 L OR
  • Predicted postresection FEV_1 greater than 1.0 L
  • No postobstructive pneumonia

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No serious infection
  • No other serious medical condition that would preclude study compliance
  • No prior allergic reactions to drugs containing Cremophor
  • No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior systemic chemotherapy for NSCLC
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior systemic radiotherapy for NSCLC
  • No concurrent radiotherapy

Surgery:

  • At least 5 years since prior resection of lung disease

Other:

  • No other concurrent investigational therapy
  • No other concurrent anticancer therapy

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）

武器和干预

参与者组/臂
干预/治疗
实验性的：preooperative chemo followed by surgery
carboplatin paclitaxel conventional surgery
药品：卡铂
程序：常规手术
药品：紫杉醇
有源比较器：Surgery alone
conventional surgery
程序：常规手术

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

Southwest Oncology Group

合作者

National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Radiation Therapy Oncology Group
North Central Cancer Treatment Group

调查人员

  • 学习椅：Corey J. Langer, MD、Fox Chase Cancer Center
  • 学习椅：Joseph A. Treat, MD、Fox Chase 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

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

1999年10月1日

初级完成 (实际的)

2005年5月1日

研究完成 (实际的)

2012年11月1日

研究注册日期

首次提交

1999年11月1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)

2013年1月31日

上次提交的符合 QC 标准的更新

2013年1月30日

最后验证

2013年1月1日

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

  • CDR0000067223
  • U10CA032102 (美国 NIH 拨款/合同)
  • S9900 (其他标识符：NCCTG)
  • RTOG-L0015 (其他标识符：RTOG)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

卡铂的临床试验

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 Djibouti

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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