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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
Not Enrolling
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


- 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

- 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

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


- 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



- 18 and over

Performance status:

- ECOG 0-2 OR

- Zubrod 0-2

Life expectancy:

- Not specified


- Not specified


- Not specified


- Not specified


- See Disease Characteristics


- Medically fit for surgery

- No other malignancies within the past 5 years except curatively treated malignancies
with low risk of recurrence


Biologic therapy:

- Not specified


- No prior chemotherapy for NSCLC

- Adjuvant chemotherapy allowed

Endocrine therapy:

- Not specified


- No prior radiotherapy for NSCLC

- Adjuvant radiotherapy allowed


- See Disease Characteristics

- At least 5 years since prior ipsilateral thoracotomy or thoracostomy

Type of Study:


Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Robbin G. Cohen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center


United States: Federal Government

Study ID:




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



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