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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 has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003901
First received: November 1, 1999
Last updated: November 5, 2011
Last verified: October 2004
History of Changes
  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 3

Study Type: Interventional
Study Design: Primary Purpose: 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
U.S. FDA Resources

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

Estimated Enrollment: 1200
Study Start Date: July 1999
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
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

  Show 58 Study Locations
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

Publications:

ClinicalTrials.gov Identifier: NCT00003901     History of Changes
Other Study ID Numbers: CDR0000067072, ACOSOG-Z0040
Study First Received: November 1, 1999
Last Updated: November 5, 2011
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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013