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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.
Study NCT00003901   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
July 1999
 
 
 
Complete list of historical versions of study NCT00003901 on ClinicalTrials.gov Archive Site
 
 
 
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
A Prospective Study of the Prognostic Significance of Occult Metastases in the Patient With Resectable Non-Small Cell Lung Carcinoma

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.

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.

Phase III
Interventional
Diagnostic
Lung Cancer
  • Other: immunohistochemistry staining method
  • Procedure: biopsy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
1200
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00003901
 
CDR0000067072, ACOSOG-Z0040
American College of Surgeons
National Cancer Institute (NCI)
Study Chair: Robbin G. Cohen, MD USC/Norris Comprehensive Cancer Center
National Cancer Institute (NCI)
October 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP