Video-assisted wedge resection (VAR) and radiotherapy for high risk T1 non-small cell lung cancer: A phase II study

Originating Group

CALGB 9335

P.I.: Dr. Hani Shennib

Participating Groups

ECOG #C9335 Dr. R. Keenan

Objectives

  1. To determine the feasibility of treating patients with cardiopulmonary dysfunction and T1 peripheral NSCLC by video-assisted throacoscopic resection (VAR) and radiotherapy
  2. To describe the incidence of locoregional recurrence among high risk patients with T1 peripheral non-small cell lung cancer treated by video-assisted wedge resection (VAR) and radiotherapy
  3. To describe survival and disease-free survival in this patient group
  4. To determine the technical feasibility of achieving a complete resection with VAR
  5. To describe the rate of conversion to open thoracotomy
  6. To describe the short-term and long-term complications associated with VAR
  7. To describe the toxicity associated with adjuvant radiotherapy after VAR

Eligibility

  1. Single, peripheral T1 lung cancer or suspected cancer
  2. Pulmonary dysfunction (FEV1.0 <40% predicted, DLCO<50% predicted, VO2 max <15ml/kg/min., PaCO2 >45mm Hg., O2 requirement)
  3. Lesions accessible for VAR resection
  4. No metastatic or N2 disease (by CT scan, >1cm.)
  5. No concomitant malignancy
  6. No prior chest radiotherapy
  7. Performance status 0-2
  8. Weight loss <= 10% in past 6 months
  9. Bronchoscopy: negative

Schema

Comments

activated 11/94
accrual goal 65 patients
current accrual 66/65 as of 9/30/99
closure date 9/30/99