Lung Cancer Clinical Trial
Official title:
VIDEO ASSISTED WEDGE RESECTION (VAR) AND RADIOTHERAPY FOR HIGH RISK T1 NON-SMALL CELL LUNG CANCER: A PHASE II STUDY
RATIONALE: Video-assisted surgery followed by radiation therapy may be an effective
treatment in patients whose poor heart and lung function make them high risk for standard
surgery.
PURPOSE: Phase II trial to study the effectiveness of video-assisted surgery followed by
radiation therapy in treating patients with stage I non-small cell lung cancer and poor
heart and lung function.
OBJECTIVES:
- Determine the feasibility of video-assisted thoracoscopic wedge resection (VAR)
followed by radiotherapy in patients with stage I non-small cell lung cancer and
cardiopulmonary dysfunction.
- Determine the incidence of locoregional recurrence in patients treated with this
regimen.
- Determine the overall and disease-free survival in patients treated with this regimen.
- Determine the technical feasibility of ipsilateral lymph node sampling and complete
resection with VAR in these patients.
- Determine the incidence of conversion to open thoracotomy in these patients.
- Determine the short- and long-term complications associated with VAR in these patients.
- Determine the toxicity of adjuvant radiotherapy after VAR in these patients.
OUTLINE: This is a multicenter study.
Patients undergo video-assisted thoracoscopic wedge resection. Surgeons attempt sampling and
identification of all ipsilateral, mediastinal, and hilar lymph nodes. When accessible,
lobar lymph nodes must also be sampled. If the tumor margins are positive, further resection
of the margins must be attempted. Open thoracotomy may be required for technical reasons.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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