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A Prospective Study of the Prognostic Significance of Occult Metastases in the Patient With Resectable Non-Small Cell Lung Carcinoma

Phase 3
18 Years
Not Enrolling
Lung Cancer

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Trial Information

A Prospective Study of the Prognostic Significance of Occult Metastases in the Patient With Resectable Non-Small Cell Lung Carcinoma


- 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

- 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

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.

Inclusion Criteria


- 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



- 18 and over

Performance status:

- ECOG 0-2 OR

- Zubrod 0-2

Life expectancy:

- Not specified


- Not specified


- Not specified


- Not specified


- See Disease Characteristics


- Medically fit for surgery

- No other malignancies within the past 5 years except curatively treated malignancies
with low risk of recurrence


Biologic therapy:

- Not specified


- No prior chemotherapy for NSCLC

- Adjuvant chemotherapy allowed

Endocrine therapy:

- Not specified


- No prior radiotherapy for NSCLC

- Adjuvant radiotherapy allowed


- See Disease Characteristics

- At least 5 years since prior ipsilateral thoracotomy or thoracostomy

Type of Study:


Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Robbin G. Cohen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center


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
  • stage IIIA non-small cell lung cancer
  • adenocarcinoma of the lung
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis



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 Chicago Cancer Research Center Chicago, Illinois  60637
Ireland Cancer Center Cleveland, Ohio  44106-5065
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Hurley Medical Center Flint, Michigan  48503
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Cancer Center at the University of Virginia Charlottesville, Virginia  22908
Bayfront Medical Center Saint Petersburg, Florida  33701
McLaren Regional Cancer Center Flint, Michigan  48432
Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224
LDS Hospital Salt Lake City, Utah  84143
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee, Wisconsin  53295
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
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
MetroHealth's Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44106
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center Nashville, Tennessee  37232-2516
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Veterans Affairs Medical Center - Seattle Seattle, Washington  98108
Allegheny General Hospital Pittsburgh, Pennsylvania  15212-4772
University of California Davis Cancer Center Sacramento, California  95817
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
Southern Illinois University School of Medicine Springfield, Illinois  62794-9658
Cancer Institute at Oregon Health and Science University Portland, Oregon  97201-3098
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus Nashville, Tennessee  37212
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Cottonwood Hospital Medical Center Murray, Utah  84107
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
William Beaumont Hospital - Royal Oak Royal Oak, Michigan  48073-6769
University Hospital at State University of New York - Upstate Medical University Syracuse, New York  13210
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Fort Lauderdale, Florida  33308
Providence Cancer Center at Providence Portland Medical Center Portland, Oregon  97213-2967
Lankenau Cancer Center at Lankenau Hospital Wynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - Omaha Omaha, Nebraska  68105
Huntington Cancer Center at Huntington Hospital Pasadena, California  91105
Alexian Brothers Medical Center Elk Grove Village, Illinois  60007
Jewish Hospital Louisville, Kentucky  40202-1886
Creighton University School of Medicine Omaha, Nebraska  68131
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
Saint Thomas Hospital Nashville, Tennessee  37205
Providence Cancer Center Mobile, Alabama  36608
University of Colorado Health Sciences Center - Denver Denver, Colorado  80262
Cancer Institute at St. John's Hospital Springfield, Illinois  62701
Siteman Cancer Center Saint Louis, Missouri  63110
Abramson Cancer Center of the University of Pennsylvania Medical Center Philadelphia, Pennsylvania  19104-4283