Randomized Trial of Mediastinal Lymph Node Sampling Versus Complete Lymphadenectomy During Pulmonary Resection in the Patient With N0 and N1 (Less Than Hilar) Non-Small Cell Carcinoma
OBJECTIVES:
- Compare whether a complete mediastinal lymph node dissection versus mediastinal lymph
node sampling improves overall survival of patients with N0 or non-hilar N1 non-small
cell lung cancer undergoing resection.
- Compare these two methods with reference to identification of occult mediastinal lymph
node involvement.
- Compare the effect of these two methods on operative time and duration of postoperative
complications, including chest tube drainage and length of hospitalization for these
patients.
- Compare the effect of these two methods on local recurrence free survival and local
regional recurrence free survival of these patients.
OUTLINE: This is a randomized study.
Patients undergo lymph node sampling from multiple sites inside the chest. Patients with
negative lymph nodes are randomized to 1 of 2 treatment arms.
- Arm I (Mediastinal Lymph Node Sampling): No more lymph nodes are removed. Patients
undergo pulmonary resection.
- Arm II (Mediastinal Lymph Node Dissection): Patients undergo removal of nearly all of
the lymph nodes from the central part of the chest between the lungs, followed by
pulmonary resection.
Patients are followed at 4, 6, 8, 12, 18, 24, and 36 months and then annually thereafter
until death.
PROJECTED ACCRUAL: A total of 1,000 patients (500 per arm) will be accrued for this study
over 5 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Mark S. Allen, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000066988
NCT00003831
July 1999
Name | Location |
---|---|
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 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Stanford University Medical Center | Stanford, California 94305-5408 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Hurley Medical Center | Flint, Michigan 48503 |
Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
LDS Hospital | Salt Lake City, Utah 84143 |
Massey Cancer Center | Richmond, Virginia 23298-0037 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center | Orange, California 92868 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
Long Island Cancer Center at Stony Brook University Hospital | Stony Brook, New York 11790-7775 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
Veterans Affairs Medical Center - Cincinnati | Cincinnati, Ohio 45220-2288 |
Veterans Affairs Medical Center - Seattle | Seattle, Washington 98108 |
Allegheny General Hospital | Pittsburgh, Pennsylvania 15212-4772 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
West Virginia University Hospitals | Morgantown, West Virginia 26506-9300 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Mobile Infirmary Medical Center | Mobile, Alabama 36640-0460 |
Medical Center of Central Georgia | Macon, Georgia 31201 |
Southern Illinois University School of Medicine | Springfield, Illinois 62794-9658 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Holmes Regional Medical Center | Melbourne, Florida 32901-3276 |
Central Baptist Hospital | Lexington, Kentucky 40503 |
Valley Hospital | Ridgewood, New Jersey 07450 |
Emory University School of Medicine | Atlanta, Georgia 30322 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center | Los Angeles, California 90048 |
Jackson Memorial Hospital | Miami, Florida 33136 |
William Beaumont Hospital - Royal Oak | Royal Oak, Michigan 48073-6769 |
Earle A. Chiles Research Institute at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Abramson Cancer Center at University of Pennsylvania Medical Center | Philadelphia, Pennsylvania 19104 |
Veterans Affairs Medical Center - Gainesville | Gainesville, Florida 32608-1197 |
Edward Hospital Cancer Center | Naperville, Illinois 60540 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
UPMC St. Margaret | Pittsburgh, Pennsylvania 15215 |
Veterans Affairs Medical Center - Omaha | Omaha, Nebraska 68105 |
Presbyterian-University Hospital | Pittsburgh, Pennsylvania 15213 |
Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital | Cooperstown, New York 13326 |
Huntington Cancer Center at Huntington Hospital | Pasadena, California 91105 |
Shands Cancer Center at the University of Florida | Gainesville, Florida 32610-0342 |
Alexian Brothers Medical Center | Elk Grove Village, Illinois 60007 |
St. John's Hospital | Springfield, Illinois 62701 |
Jewish Hospital | Louisville, Kentucky 40202-1886 |
Medical Center of Southwest Louisiana | Lafayette, Louisiana 70506 |
Rhode Island Hospital | Boston, Massachusetts 02114-2620 |
St. Luke's Hospital | Duluth, Minnesota 55805-2193 |
Creighton University School of Medicine | Omaha, Nebraska 68131 |
Englewood Hospital Oncology Program | Englewood, New Jersey 07631 |
Trinity Hospital | Minot, North Dakota 58701 |
Tri-Health Good Samaritan Hospital | Cincinnati, Ohio 45220 |
Westmoreland Regional Hospital | Greensburg, Pennsylvania 15601-2282 |
Jameson Memorial Hospital | New Castle, Pennsylvania 16105 |
Temple University Hospital | Philadelphia, Pennsylvania 19140 |
St. Clair Memorial Hospital | Pittsburgh, Pennsylvania 15243-1899 |
University of Pittsburg Medical Center - Shadyside Hospital | Pittsburgh, Pennsylvania 15213-2582 |
Saint Thomas Hospital | Nashville, Tennessee 37205 |