NCT00002624

Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function

VIDEO ASSISTED WEDGE RESECTION (VAR) AND RADIOTHERAPY FOR HIGH RISK T1 NON-SMALL CELL LUNG CANCER: A PHASE II STUDY

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	adjuvant therapy
PROCEDURE	diagnostic thoracoscopy
PROCEDURE	therapeutic thoracoscopy
PROCEDURE	video-assisted surgery
RADIATION	radiation therapy

Timeline

• Start date: 1994-12-01
• Primary completion: 2005-04-01
• Completion: 2005-08-01
• First posted: 2003-01-27
• Last updated: 2016-07-14

Locations

16 sites across 4 countries: United States, Australia, Peru, Puerto Rico