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Pre-resection minimally invasive surgical restaging of Stage III (mediastinal node positive) non-small cell lung cancer (NSCLC)

Originating Group

CALGB 39803

Co P.I.'s: Dr. Malcolm DeCamp and Dr. Michael Jatklitsch

Participating Groups

Objectives

  1. To evaluate the feasibility of using videothoracoscopy to access and identify residual viable cancer in mediastinal lymph nodes and/or to evaluate for other conditions which render patients unresectable (pleural carcinomatosis or T4 primary tumors) following prior mediastinoscopy and a period of neoadjuvant theapy for Stage IIIa (N2) NSCLC.
  2. To evaluate the safety (morbidity and mortality) of pre-resectional thoracoscopic therapy for Stage IIIa (N2) NSCLC.
  3. To assess the accuracy (falce-negative rate) for thoracoscopic mediastinal restaging after prior mediastinoscopy and induction therapy.

Eligibility

  1. Histologic documentation of Stage IIIa NSCLC by mediastinoscopy performed prior to induction therapy. Previously treated relapsed patients are not eligible.
  2. Prior treatment: >2 cycles of platinum-based combination chemotherapy with or without radiotherapy (>=40Gy) or radiotherapy alone (>=40Gy) must be completed within 42 days of registration.
  3. No distant metastatic disease or local disease progression. Patients with stable or responding local disease are eligible. Those with local disease progression defined as a 25% increase in local tumor size or the appearance of new areas of malignant disease are ineligible.
  4. No previous intrapleural surgery on the ipsilateral side.
  5. ECOG performance status 0-2.

Schema

Comments

activated 12/15/98
target accrual 75 patients
accrual 15/75 patients as of 10/2000
open to VATS credentialled surgeons only



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