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)
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Paul A. Bunn, MD
Study Chair
University of Colorado, Denver
United States: Federal Government
CDR0000067223
NCT00004011
October 1999
November 2012
Name | Location |
---|---|
Akron City Hospital | Akron, Ohio 44304 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Cancer Center of Albany Medical Center | Albany, New York 12208 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
St. Luke's Medical Center | Milwaukee, Wisconsin 53215 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Hurley Medical Center | Flint, Michigan 48503 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
Bloomington Hospital | Bloomington, Indiana 47402 |
Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction, Colorado 81502 |
Methodist Cancer Center at Methodist Hospital | Indianapolis, Indiana 46202 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
MD Anderson Cancer Center Orlando | Orlando, Florida 32806 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
Marshfield Clinic | Marshfield, Wisconsin 54449 |
Radiation Oncology Associates of West Alabama | Tuscallosa, Alabama 35401 |
Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
Mount Diablo Medical Center | Concord, California 94524-4110 |
California Cancer Center | Fresno, California 93720 |
Saint Agnes Cancer Center | Fresno, California 93720 |
Sutter Health Western Division Cancer Research Group | Greenbrae, California 94904 |
Veterans Affairs Medical Center - Long Beach | Long Beach, California 90822 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
O'Connor Hospital | San Jose, California 95128 |
CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
David Grant Medical Center | Travis Air Force Base, California 94535 |
Memorial Hospital Cancer Center | Colorado Springs, Colorado 80909 |
Halifax Medical Center | Daytona Beach, Florida 32114 |
Baptist Hospital of Miami | Miami, Florida 33176-2197 |
Florida Radiation Oncology Group | Orange Park, Florida 32073 |
Gulf Coast Cancer Treatment Center | Panama City, Florida 32405-4587 |
Sarasota Radiation and Medical Oncology Center | Sarasota, Florida 34233 |
Medical Center/John B. Amos Community Cancer Center | Columbus, Georgia 31902 |
Northwest Community Hospital | Arlington Heights, Illinois 60005 |
Ingalls Memorial Hospital | Harvey, Illinois 60426 |
Lutheran General Cancer Care Center | Park Ridge, Illinois 60068 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
Wendt Regional Cancer Center of Finley Hospital | Dubuque, Iowa 52001 |
Mary Bird Perkins Cancer Center | Baton Rouge, Louisiana 70809 |
Maine Medical Center | Portland, Maine 04102 |
Anne Arundel Oncology Center | Annapolis, Maryland 21401 |
Greater Baltimore Medical Center and Cancer Center | Baltimore, Maryland 21204 |
Harbor Hospital Center | Baltimore, Maryland 21225 |
Cape Cod Hospital | Hyannis, Massachusetts 02601 |
Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain, Massachusetts 02130 |
McLaren Regional Cancer Center | Flint, Michigan 48432 |
Marquette General Hospital | Marquette, Michigan 49855 |
Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
Elliot Regional Cancer Center | Manchester, New Hampshire 03103 |
John F. Kennedy Medical Center | Edison, New Jersey 08818 |
Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
Community Medical Center | Toms River, New Jersey 08755 |
New York Methodist Hospital | Brooklyn, New York 11215-3609 |
Champlain Valley Physicians Hospital Medical Center | Plattsburgh, New York 12901 |
Akron General Medical Center | Akron, Ohio 44302 |
University Hospitals of Cleveland | Cleveland, Ohio 44106 |
CCOP - Columbus | Columbus, Ohio 43206 |
CCOP - Dayton | Kettering, Ohio 45429 |
Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
Veterans Affairs Medical Center - Philadelphia | Philadelphia, Pennsylvania 19104 |
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
Mercy Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15219 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Mercy Hospital Cancer Center - Scranton | Scranton, Pennsylvania 18501 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
CCOP - Greenville | Greenville, South Carolina 29615 |
Harrington Cancer Center | Amarillo, Texas 79106 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
Bayshore Medical Center | Pasadena, Texas 77504 |
Dixie Regional Medical Center | Saint George, Utah 84770 |
LDS Hospital | Salt Lake City, Utah 84143 |
Green Mountain Oncology Group | Rutland, Vermont 05701 |
Naval Medical Center, Portsmouth | Portsmouth, Virginia 23708-2197 |
Deaconess Medical Center | Spokane, Washington 99210-0248 |
Yakima Valley Memorial Hospital | Yakima, Washington 98902 |
St. Vincent Hospital | Green Bay, Wisconsin 54307-3508 |
Veterans Affairs Medical Center - Madison | Madison, Wisconsin 53705 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Southern Wisconsin Radiotherapy Center | Madison, Wisconsin 53713 |
Community Memorial Hospital | Menomonee Falls, Wisconsin 53051 |
Columbia Hospital | Milwaukee, Wisconsin 53211 |
Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44106 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville, Tennessee 37232-2516 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
Naval Medical Center - San Diego | San Diego, California 92134-3202 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
CCOP - Oklahoma | Tulsa, Oklahoma 74136 |
Allegheny General Hospital | Pittsburgh, Pennsylvania 15212-4772 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
Foundation for Cancer Research and Education | Phoenix, Arizona 85013 |
Bay Medical Center | Panama City, Florida 32401 |
Peninsula Regional Medical Center | Salisbury, Maryland 21801 |
MidMichigan Medical Center - Midland | Midland, Michigan 48670 |
Trinitas Hospital - Jersey Street Campus | Elizabeth, New Jersey 07201 |
Monmouth Medical Center | Long Branch, New Jersey 07740-6395 |
South Jersey Regional Cancer Center | Millville, New Jersey 08332 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Atlantic City Medical Center | Pomona, New Jersey 08240 |
Associated Radiologists, P.A. | Warren, New Jersey 07059 |
St. John Health System | Tulsa, Oklahoma 74104 |
University of Utah Health Sciences Center | Salt Lake City, Utah 84132 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
CCOP - Beaumont | Royal Oak, Michigan 48073-6769 |
CCOP - Colorado Cancer Research Program, Incorporated | Denver, Colorado 80224 |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15236 |
Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
Tulane Cancer Center at Tulane University Hospital and Clinic | New Orleans, Louisiana 70112 |
Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
St. Louis University Hospital Cancer Center | Saint Louis, Missouri 63110 |
Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
James Graham Brown Cancer Center at University of Louisville | Louisville, Kentucky 40202 |
Tufts - New England Medical Center | Boston, Massachusetts 02111 |
Roger Williams Medical Center | Providence, Rhode Island 02908-4735 |
Fairview University Medical Center - University Campus | Minneapolis, Minnesota 55455 |
SUNY Downstate Medical Center | Brooklyn, New York 11203 |
Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
Stanford Cancer Center at Stanford University Medical Center | Stanford, California 94305 |
DCH Cancer Treatment Center | Tuscaloosa, Alabama 35401 |
Radiation Medical Group, Incorporated | San Diego, California 92101 |
Hospital of St. Raphael | New Haven, Connecticut 06511 |
Holmes Regional Medical Center | Melbourne, Florida 32901-3276 |
Regional Radiation Oncology Center at Rome | Rome, Georgia 30165 |
Community Regional Cancer Care | Indianapolis, Indiana 46219 |
Central Baptist Hospital | Lexington, Kentucky 40503 |
William Beaumont Hospital - Troy | Troy, Michigan 48098 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital | Mount Holly, New Jersey 08060 |
Valley Hospital | Ridgewood, New Jersey 07450 |
Radiation Oncology Associates of Albuquerque | Albuquerque, New Mexico 87109 |
Finger Lakes Radiation Oncology Center | Clifton Springs, New York 14432 |
Vassar Brothers Medical Center | Poughkeepsie, New York 12601 |
Riverhill Radiation Oncology | Yonkers, New York 10701 |
Trinity Cancer Care Center | Minot, North Dakota 58701 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
St. Luke's Hospital Cancer Center | Bethlehem, Pennsylvania 18015 |
Mercy Fitzgerald Hospital | Darby, Pennsylvania 19023 |
Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
RMH Regional Cancer Center | Harrisonburg, Virginia 22801 |
Bon Secours - St. Mary's Hospital | Richmond, Virginia 23226 |
Waukesha Memorial Hospital Regional Cancer Center | Waukesha, Wisconsin 53188 |
Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California 92354 |
Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
Massey Cancer Center at Virginia Commonwealth University | Richmond, Virginia 23298-0037 |
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | Omaha, Nebraska 68114-4199 |
Wellspan Health - York Cancer Center | York, Pennsylvania 17403 |
CCOP - Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Comprehensive Cancer Institute | Huntsville, Alabama 35801 |
Torrance Memorial Medical Center | Torrance, California 90505 |
Sibley Memorial Hospital | Washington, District of Columbia 20016 |
21st Century Oncology - Fort Myers | Fort Myers, Florida 33901-8082 |
Tallahassee Memorial Hospital | Tallahassee, Florida 32308 |
CCOP - Scott and White Hospital | Peoria, Illinois 61602 |
St. Elizabeth Medical Center | Edgewood, Kentucky 41017 |
St. Agnes Cancer Center | Baltimore, Maryland 21229 |
NSMC Cancer Center | Peabody, Massachusetts 01960 |
Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
Medical Center of Princeton | Princeton, New Jersey 08540 |
Batte Cancer Center at Northeast Medical Center | Concord, North Carolina 28025 |
Cancer Center at Christ Hospital | Cincinnati, Ohio 45219 |
Parma Community General Hospital | Parma, Ohio 44129 |
Arlington Cancer Center | Arlington, Texas 76012 |
Vermont Cancer Center at University of Vermont | Burlington, Vermont 05405-0075 |
Cancer Institute at Virginia Mason Medical Center | Seattle, Washington 98111 |
Cottonwood Hospital Medical Center | Murray, Utah 84107 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |
Shands Cancer Center at the University of Florida Health Science Center | Gainesville, Florida 32610-0296 |
William Beaumont Hospital - Royal Oak | Royal Oak, Michigan 48073-6769 |
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina | Greenville, North Carolina 27858-4354 |
Medcenter One Health System | Bismarck, North Dakota 58501 |
MBCCOP-Our Lady of Mercy Cancer Center | Bronx, New York 10466 |
Abramson Cancer Center at University of Pennsylvania Medical Center | Philadelphia, Pennsylvania 19104 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Coborn Cancer Center | Saint Cloud, Minnesota 56303 |
Fox Chase Cancer Center at St. Francis Medical Center | Trenton, New Jersey 08629 |
Altru Cancer Center | Grand Forks, North Dakota 58206 |
CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale, Arizona 85259 |
Cancer Care Center at Advocate Good Samaritan Hospital | Downers Grove, Illinois 60515 |
Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County | Madisonville, Kentucky 42431 |
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital | Allentown, Pennsylvania 18105 |
All Saints Cancer Center at All Saints Healthcare | Racine, Wisconsin 53405 |
Schiffler Cancer Center at Wheeling Hospital | Wheeling, West Virginia 26003 |
University of Miami Sylvester Cancer Center | Miami, Florida 33136 |
Huntington Cancer Center at Huntington Hospital | Pasadena, California 91105 |
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center | Pomona, California 91767 |
St. John's Cancer Center at St. John's Medical Center | Anderson, Indiana 46016 |
Ball Memorial Hospital Cancer Center | Muncie, Indiana 47303-3499 |
Siteman Cancer Center | Saint Louis, Missouri 63110 |
Frank C. Love Cancer Institute at St. Anthony Hospital | Oklahoma City, Oklahoma 73101 |
Huntsville Hospital | Huntsville, Alabama 35807 |
Montgomery Cancer Center | Montgomery, Alabama 36106-3657 |
Radiation Oncology Centers - Sacramento | Sacramento, California 95816 |
Louisville Radiation Oncology Center at Caritas Regional Cancer Center | Louisville, Kentucky 40215 |
Beth Israel Medical Center - Philipps Ambulatory Care Center | New York, New York 10003 |
Dale and Frances Hughes Cancer Center | East Stroudsburg, Pennsylvania 18301 |
Wilkes-Barre General Hospital | Wilkes-Barre, Pennsylvania 18764-0001 |
West Tennessee Cancer Center at Jackson-Madison County General Hospital | Jackson, Tennessee 38301 |