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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
N/A
Not Enrolling
Both
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


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 InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Chicago Cancer Research CenterChicago, Illinois  60637
Ireland Cancer CenterCleveland, Ohio  44106-5065
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Hurley Medical CenterFlint, Michigan  48503
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Bayfront Medical CenterSaint Petersburg, Florida  33701
McLaren Regional Cancer CenterFlint, Michigan  48432
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
LDS HospitalSalt Lake City, Utah  84143
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Long Island Cancer Center at Stony Brook University HospitalStony Brook, New York  11790-7775
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
MetroHealth's Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44106
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
University of California Davis Cancer CenterSacramento, California  95817
West Virginia University HospitalsMorgantown, West Virginia  26506-9300
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
Southern Illinois University School of MedicineSpringfield, Illinois  62794-9658
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville CampusNashville, Tennessee  37212
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Cottonwood Hospital Medical CenterMurray, Utah  84107
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
William Beaumont Hospital - Royal OakRoyal Oak, Michigan  48073-6769
University Hospital at State University of New York - Upstate Medical UniversitySyracuse, New York  13210
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - OmahaOmaha, Nebraska  68105
Huntington Cancer Center at Huntington HospitalPasadena, California  91105
Alexian Brothers Medical CenterElk Grove Village, Illinois  60007
Jewish HospitalLouisville, Kentucky  40202-1886
Creighton University School of MedicineOmaha, Nebraska  68131
Westmoreland Regional HospitalGreensburg, Pennsylvania  15601-2282
Jameson Memorial HospitalNew Castle, Pennsylvania  16105
Temple University HospitalPhiladelphia, Pennsylvania  19140
St. Clair Memorial HospitalPittsburgh, Pennsylvania  15243-1899
Saint Thomas HospitalNashville, Tennessee  37205
Providence Cancer CenterMobile, Alabama  36608
University of Colorado Health Sciences Center - DenverDenver, Colorado  80262
Cancer Institute at St. John's HospitalSpringfield, Illinois  62701
Siteman Cancer CenterSaint Louis, Missouri  63110
Abramson Cancer Center of the University of Pennsylvania Medical CenterPhiladelphia, Pennsylvania  19104-4283