RATIONALE: Surgical removal of all lymph nodes in the chest may kill cancer cells that have spread from tumors in the lung. It is not yet known whether complete removal of all lymph nodes in the chest is more effective than removal of selected lymph nodes in treating patients who have stage I or stage II non-small cell lung cancer.

PURPOSE: Randomizedphase III trial to compare the effectiveness of complete removal of all lymph nodes in the chest with that of selected removal of lymph nodes during lung cancer surgery in treating patients who have stage I or stage II non-small cell lung cancer.

Condition	Treatment or Intervention	Phase
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	Procedure: conventional surgery  Procedure: surgery	Phase III

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS: Age:

• 18 and over

Performance status:

• ECOG 0-2 OR
• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• 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

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for NSCLC

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy for NSCLC

Surgery:

• See Disease Characteristics

Alabama
      Mobile Infirmary Medical Center, Mobile,  Alabama,  36640-0460,  United States
California
      Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States
      Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center, Orange,  California,  92868,  United States
      Huntington Cancer Center at Huntington Hospital, Pasadena,  California,  91105,  United States
      Stanford University Medical Center, Stanford,  California,  94305-5408,  United States
      UCSF Comprehensive Cancer Center, San Francisco,  California,  94143-0128,  United States
Florida
      Holmes Regional Medical Center, Melbourne,  Florida,  32901,  United States
      Jackson Memorial Hospital, Miami,  Florida,  33136,  United States
      Shands Cancer Center at the University of Florida, Gainesville,  Florida,  32610-0342,  United States
      Veterans Affairs Medical Center - Gainesville, Gainesville,  Florida,  32608-1197,  United States
Georgia
      Emory University School of Medicine, Atlanta,  Georgia,  30322,  United States
      Medical Center of Central Georgia, Macon,  Georgia,  31201,  United States
Illinois
      Alexian Brothers Medical Center, Elk Grove Village,  Illinois,  60007,  United States
      Edward Hospital Cancer Center, Naperville,  Illinois,  60540,  United States
      Loyola University Medical Center, Maywood,  Illinois,  60153,  United States
      Southern Illinois University School of Medicine, Springfield,  Illinois,  62702,  United States
      St. John's Hospital, Springfield,  Illinois,  62701,  United States
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States
Kentucky
      Central Baptist Hospital, Lexington,  Kentucky,  40503,  United States
      Jewish Hospital, Louisville,  Kentucky,  40202-1886,  United States
Louisiana
      Medical Center of Southwest Louisiana, Lafayette,  Louisiana,  70506,  United States
Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114-2620,  United States
      Rhode Island Hospital, Boston,  Massachusetts,  02114-2620,  United States
Michigan
      Hurley Medical Center, Flint,  Michigan,  48503,  United States
      William Beaumont Hospital - Royal Oak, Royal Oak,  Michigan,  48073,  United States
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
      St. Luke's Hospital, Duluth,  Minnesota,  55805-2193,  United States
      Veterans Affairs Medical Center - Minneapolis, Minneapolis,  Minnesota,  55417,  United States
Missouri
      Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States
      Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia,  Missouri,  65203,  United States
Nebraska
      Creighton University School of Medicine, Omaha,  Nebraska,  68131,  United States
      Veterans Affairs Medical Center - Omaha, Omaha,  Nebraska,  68105,  United States
New Jersey
      Englewood Hospital Oncology Program, Englewood,  New Jersey,  07631,  United States
      Valley Hospital, Ridgewood,  New Jersey,  07450,  United States
New York
      James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester,  New York,  14642,  United States
      Long Island Cancer Center at Stony Brook University Hospital, Stony Brook,  New York,  11790-8191,  United States
      Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital, Cooperstown,  New York,  13326,  United States
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
      New York Weill Cornell Cancer Center at Cornell University, New York,  New York,  10021,  United States
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States
North Dakota
      Trinity Hospital, Minot,  North Dakota,  58701,  United States
Ohio
      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0558,  United States
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States
      Tri-Health Good Samaritan Hospital, Cincinnati,  Ohio,  45220,  United States
      Veterans Affairs Medical Center - Cincinnati, Cincinnati,  Ohio,  45220-2288,  United States
Oregon
      Earle A. Chiles Research Institute at Providence Portland Medical Center, Portland,  Oregon,  97213-2967,  United States
Pennsylvania
      Abramson Cancer Center at University of Pennsylvania Medical Center, Philadelphia,  Pennsylvania,  19104-4283,  United States
      Allegheny General Hospital, Pittsburgh,  Pennsylvania,  15212-4772,  United States
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111-2497,  United States
      Jameson Memorial Hospital, New Castle,  Pennsylvania,  16105,  United States
      Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia,  Pennsylvania,  19107-5541,  United States
      Lankenau Cancer Center at Lankenau Hospital, Wynnewood,  Pennsylvania,  19096,  United States
      Presbyterian-University Hospital, Pittsburgh,  Pennsylvania,  15213,  United States
      St. Clair Memorial Hospital, Pittsburgh,  Pennsylvania,  15243-1899,  United States
      Temple University Hospital, Philadelphia,  Pennsylvania,  19140,  United States
      University of Pittsburg Medical Center - Shadyside Hospital, Pittsburgh,  Pennsylvania,  15213-2582,  United States
      UPMC St. Margaret, Pittsburgh,  Pennsylvania,  15215,  United States
      Western Pennsylvania Hospital, Pittsburgh,  Pennsylvania,  15224,  United States
      Westmoreland Regional Hospital, Greensburg,  Pennsylvania,  15601-2282,  United States
Tennessee
      Saint Thomas Hospital, Nashville,  Tennessee,  37205,  United States
Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States
Utah
      LDS Hospital, Salt Lake City,  Utah,  84143,  United States
Virginia
      Cancer Center at the University of Virginia, Charlottesville,  Virginia,  22908,  United States
      Massey Cancer Center, Richmond,  Virginia,  23298-0037,  United States
Washington
      Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle,  Washington,  98104,  United States
      University of Washington Medical Center, Seattle,  Washington,  98195-6310,  United States
      Veterans Affairs Medical Center - Seattle, Seattle,  Washington,  98195-6310,  United States
West Virginia
      West Virginia University Hospitals, Morgantown,  West Virginia,  26506-9300,  United States
Wisconsin
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-7375,  United States
Australia, Victoria
      Peter MacCallum Cancer Centre, East Melbourne,  Victoria,  3002,  Australia
      St. Vincent's Hospital, Fitzroy,  Victoria,  3065,  Australia
Canada, Ontario
      Cancer Care Ontario-London Regional Cancer Centre, London,  Ontario,  N6A 4L6,  Canada
      Toronto General Hospital, Toronto,  Ontario,  M5G 2C4,  Canada

Study chairs or principal investigators

Mark S. Allen, MD,  Study Chair,  Mayo Clinic Cancer Center   

Study ID Numbers:  CDR0000066988; ACOSOG-Z0030
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003831
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08