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Pre-Resection Minimally Invasive Surgical Restaging of Stage III (Mediastinal Node Positive) Non-Small Cell Lung Cancer (NSCLC)

18 Years
Not Enrolling
Lung Cancer

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Trial Information

Pre-Resection Minimally Invasive Surgical Restaging of Stage III (Mediastinal Node Positive) Non-Small Cell Lung Cancer (NSCLC)


- Evaluate the feasibility of using videothoracoscopy to access and identify residual
viable cancer in mediastinal lymph nodes and/or evaluate for other conditions that
render patients unresectable (pleural carcinomatosis or T4 primary tumors) following
prior mediastinoscopy and a period of neoadjuvant therapy in patients with stage IIIA
non-small cell lung cancer.

- Evaluate the safety (morbidity and mortality) of preresectional thoracoscopic restaging
of these patients.

- Assess the accuracy (false-negative rate) of thoracoscopic mediastinal node restaging
in these patients.

OUTLINE: Patients undergo ipsilateral videothoracoscopic evaluation for restaging their
disease after prior mediastinoscopy and induction therapy.

Patients with negative restaging procedures are strongly encouraged to undergo anatomic
resection (lobectomy, bilobectomy, or pneumonectomy) with complete mediastinal

Patients with a positive restaging procedure may still undergo resection at the discretion
of the surgeon and other treating physicians.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 30 months.

Inclusion Criteria


- Histologically confirmed stage IIIA non-small lung cancer from a documented
mediastinoscopy prior to induction therapy

- Must have been previously treated with at least 2 courses of chemotherapy and/or
radiotherapy (at least 40 Gy) within 60 days of registration

- No evidence of distant metastases or local disease progression



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified


- Not specified


- Not specified


- Not specified


Biologic therapy:

- Not specified


- See Disease Characteristics

Endocrine therapy:

- Not specified


- See Disease Characteristics


- No prior intrapleural surgery on the ipsilateral side

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Primary Purpose: Diagnostic

Principal Investigator

Michael T. Jaklitsch, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber/Brigham and Women's Cancer Center


United States: Federal Government

Study ID:




Start Date:

September 1998

Completion Date:

March 2006

Related Keywords:

  • Lung Cancer
  • stage IIIA non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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