A Prospective Study of the Prognostic Significance of Occult Metastases in the Patient With Resectable Non-Small Cell Lung Carcinoma
18 Years
N/A
Both
Lung Cancer
Trial Information
A Prospective Study of the Prognostic Significance of Occult Metastases in the Patient With Resectable Non-Small Cell Lung Carcinoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Diagnostic
Principal Investigator
Robbin G. Cohen, MD
Investigator Role:
Study Chair
Investigator Affiliation:
USC/Norris Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000067072
NCT ID:
NCT00003901
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
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 |
| 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 |
