RATIONALE: Prognostic testing for early signs of metastases may help doctors detect metastases early and plan more effective treatment.

PURPOSE: Phase III trial to study the relationship between early signs of metastases and survival in patients who have stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery.

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 stage IIIA non-small cell lung cancer Adenocarcinoma of the Lung	Procedure: biopsies  Procedure: diagnostic test  Procedure: immunohistochemistry	Phase III

Further Study Details: 

OBJECTIVES:

• Determine the relationship between three indicators of occult metastases (cytological examination of pleural lavage, immunohistochemistry (IHC) assay of lymph nodes, and IHC assay of rib bone marrow) and survival of patients with resectable non-small cell lung cancer.
• Determine the relationship between these indicators and conventional histology.
• Model survival considering the indicators and other patient attributes that are of prime prognostic significance.
• Determine the relationships between the indicators and the site of first recurrence in these patients.
• Determine the prevalence of the indicators in these patients.
• Determine the relationships between the indicators and disease free survival in these patients.

OUTLINE: All patients undergo complete lymph node sampling or dissection. A small portion of rib is removed at this time. Some patients may have primary tumor completely removed.

Lymph nodes and bone marrow from the rib section are examined for occult metastases using immunohistochemical staining methods and standard staining methods.

Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 1200 patients will be accrued for this study over 4 years.

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven stage I, IIA, IIB, or IIIA non-small cell lung cancer (NSCLC)
• Histological confirmation may be preoperative or intraoperative
• Clinically resectable disease
• If preoperative mediastinoscopy performed, N1 or N2 disease eligible
• Squamous cell, adenocarcinoma, or large cell
• Thoracotomy with intention of complete resection planned
• Pneumonectomy, bilobectomy, lobectomy, or anatomic segmentectomy, with or without sleeve resection
• No pleural effusion

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

Pulmonary:

• See Disease Characteristics

Other:

• Medically fit for surgery
• No other malignancies within the past 5 years except curatively treated malignancies with low risk of recurrence

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for NSCLC
• Adjuvant chemotherapy allowed

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy for NSCLC
• Adjuvant radiotherapy allowed

Surgery:

• See Disease Characteristics
• At least 5 years since prior ipsilateral thoracotomy or thoracostomy

Alabama
      Mobile Infirmary Medical Center, Mobile,  Alabama,  36640-0460,  United States
      Providence Cancer Center, Mobile,  Alabama,  36608,  United States
California
      Huntington Cancer Center at Huntington Hospital, Pasadena,  California,  91105,  United States
      UCSF Comprehensive Cancer Center, San Francisco,  California,  94115,  United States
      University of California Davis Cancer Center, Sacramento,  California,  95817,  United States
      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033-0804,  United States
Colorado
      University of Colorado Health Sciences Center - Denver, Denver,  Colorado,  80262,  United States
Florida
      Bayfront Medical Center, Saint Petersburg,  Florida,  33701,  United States
      Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital, Fort Lauderdale,  Florida,  33308,  United States
Illinois
      Alexian Brothers Medical Center, Elk Grove Village,  Illinois,  60007,  United States
      Cancer Institute at St. John's Hospital, Springfield,  Illinois,  62701,  United States
      Southern Illinois University School of Medicine, Springfield,  Illinois,  62702,  United States
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States
Iowa
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1062,  United States
Kentucky
      Jewish Hospital, Louisville,  Kentucky,  40202-1886,  United States
Michigan
      Hurley Medical Center, Flint,  Michigan,  48503,  United States
      McLaren Regional Cancer Center, Flint,  Michigan,  48432,  United States
      William Beaumont Hospital - Royal Oak, Royal Oak,  Michigan,  48073,  United States
Missouri
      Siteman Cancer Center, Saint Louis,  Missouri,  63110,  United States
Nebraska
      Creighton University School of Medicine, Omaha,  Nebraska,  68131,  United States
      Veterans Affairs Medical Center - Omaha, Omaha,  Nebraska,  68105,  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,  11794-8191,  United States
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States
      University Hospital at State University of New York - Upstate Medical University, Syracuse,  New York,  13210,  United States
North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  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
      MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland,  Ohio,  44109,  United States
Oregon
      Cancer Institute at Oregon Health and Science University, Portland,  Oregon,  97239,  United States
      Providence Cancer Center at Providence Portland Medical Center, Portland,  Oregon,  97213-2967,  United States
Pennsylvania
      Abramson Cancer Center of the 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
      St. Clair Memorial Hospital, Pittsburgh,  Pennsylvania,  15243-1899,  United States
      Temple University Hospital, Philadelphia,  Pennsylvania,  19140,  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
      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-6838,  United States
      Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus, Nashville,  Tennessee,  37212,  United States
Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States
Utah
      Cottonwood Hospital Medical Center, Murray,  Utah,  84107,  United States
      LDS Hospital, Salt Lake City,  Utah,  84143,  United States
Virginia
      Cancer Center at the University of Virginia, Charlottesville,  Virginia,  22908,  United States
Washington
      Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle,  Washington,  98122-4307,  United States
      University Cancer Center at University of Washington Medical Center, Seattle,  Washington,  98195-6310,  United States
      Veterans Affairs Medical Center - Seattle, Seattle,  Washington,  98108,  United States
West Virginia
      West Virginia University Hospitals, Morgantown,  West Virginia,  26506-9300,  United States
Wisconsin
      Medical College of Wisconsin Cancer Center, Milwaukee,  Wisconsin,  53226,  United States
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-7375,  United States
      Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee,  Wisconsin,  53295,  United States
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

Robbin G. Cohen, MD,  Study Chair,  University of Southern California, Healthcare Consultation Center   

Study ID Numbers:  CDR0000067072; ACOSOG-Z0040
Record last reviewed:  November 2004
Last Updated:  November 4, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003901
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08