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

2014-07-24 14:36:12 | BioPortfolio

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.

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.

Eligible patients begin radiotherapy 2-8 weeks postoperatively. Patients with complete resection undergo radiotherapy 5 days a week for 5.6 weeks. Patients with incomplete resection undergo radiotherapy 5 days a week for 6.6 weeks.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 66 patients will be accrued for this study within approximately 22 months.

Study Design

Primary Purpose: Treatment

Conditions

Lung Cancer

Intervention

adjuvant therapy, diagnostic thoracoscopy, therapeutic thoracoscopy, video-assisted surgery, radiation therapy

Location

CCOP - Colorado Cancer Research Program, Incorporated
Denver
Colorado
United States
80224

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:36:12-0400

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