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Prognostic Study of Metastases in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Can Be Removed by Surgery
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsor: American College of Surgeons
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003901
  Purpose

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 Intervention Phase
Lung Cancer
 Other: immunohistochemistry staining method
Procedure: biopsy
 Phase III

Study Type: Interventional
Study Design: Diagnostic
Official Title: A Prospective Study of the Prognostic Significance of Occult Metastases in the Patient With Resectable Non-Small Cell Lung Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Surgery
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 1200
Study Start Date: July 1999
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003901

  Hide Study Locations
Locations
United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36640-0460
Providence Cancer Center
Mobile, Alabama, United States, 36608
United States, California
Huntington Cancer Center at Huntington Hospital
Pasadena, California, United States, 91105
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
University of California Davis Cancer Center
Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
United States, Colorado
University of Colorado Health Sciences Center - Denver
Denver, Colorado, United States, 80262
United States, Florida
Bayfront Medical Center
Saint Petersburg, Florida, United States, 33701
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
United States, Illinois
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States, 60007
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States, 62701
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1062
United States, Kentucky
Jewish Hospital
Louisville, Kentucky, United States, 40202-1886
United States, Michigan
Hurley Medical Center
Flint, Michigan, United States, 48503
McLaren Regional Cancer Center
Flint, Michigan, United States, 48432
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States, 48073
United States, Missouri
Siteman Cancer Center
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Creighton University School of Medicine
Omaha, Nebraska, United States, 68131
Veterans Affairs Medical Center - Omaha
Omaha, Nebraska, United States, 68105
United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, United States, 11794-8191
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
University Hospital at State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, Ohio
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267-0558
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
United States, Oregon
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104-4283
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Jameson Memorial Hospital
New Castle, Pennsylvania, United States, 16105
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212-4772
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
St. Clair Memorial Hospital
Pittsburgh, Pennsylvania, United States, 15243-1899
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
Westmoreland Regional Hospital
Greensburg, Pennsylvania, United States, 15601-2282
United States, Tennessee
Saint Thomas Hospital
Nashville, Tennessee, United States, 37205
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232-6838
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, United States, 37212
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
United States, Utah
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98122-4307
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6310
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States, 98108
United States, West Virginia
West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506-9300
United States, Wisconsin
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-7375
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States, 53295
Canada, Ontario
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
American College of Surgeons
National Cancer Institute (NCI)
Investigators
Study Chair: Robbin G. Cohen, MD USC/Norris Comprehensive Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: CDR0000067072, ACOSOG-Z0040
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00003901     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Carcinoma
Neoplasms
Neoplastic Processes
Pathologic Processes
 Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasm Metastasis
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 30, 2009



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