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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

Phase 3
18 Years
Open (Enrolling)
Lung Cancer

Thank you

Trial Information

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


- 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

- 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.

Inclusion Criteria


- Biopsy proven or suspected, clinically resectable stage I or II (T1 or T2, N0 or
non-hilar N1, M0) non-small cell carcinoma of the lung (NSCLC)

- Squamous cell carcinoma, adenocarcinoma, or large cell carcinoma

- If tissue diagnosis not established preoperatively, must be established
intraoperatively prior to registration/randomization

- If preoperative mediastinoscopy has been performed, hilar lymph nodes must be
certified to be less than 1 cm in the short axis diameter by preoperative CT scan,
and no N2 disease found at mediastinoscopy

- If preoperative mediastinoscopy has not been performed, all lymph nodes in the hilum
and mediastinum must measure less than 1 cm in the short axis diameter on
preoperative CT scan

- Candidate for complete resection via pneumonectomy, bilobectomy, lobectomy, or
anatomic segmentectomy with or without sleeve resection

- Planned wedge resection only not eligible

- All sampled nodes must be negative by frozen section assessment



- 18 and over

Performance status:

- ECOG 0-2 OR

- Zubrod 0-2

Life expectancy:

- Not specified


- Not specified


- Not specified


- Not specified


- Medically fit for surgery

- 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, and deemed to be at low
risk for recurrence from prior curatively treated malignancies


Biologic therapy:

- Not specified


- No prior chemotherapy for NSCLC

Endocrine therapy:

- Not specified


- No prior radiotherapy for NSCLC


- See Disease Characteristics

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Mark S. Allen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

July 1999

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • squamous cell lung cancer
  • large cell lung cancer
  • adenocarcinoma of the lung
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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