Stereotactic Radiosurgery Followed by Wedge Resection in Treating Patients With Early Stage Peripheral Non-small Cell Lung Cancer

Recurrent Non-small Cell Lung Cancer Clinical Trial

Official title: Feasibility Study of Stereotactic Body Radiation Therapy Followed by Wedge Resection for Peripherally Located Early Stage Non-small Cell Lung Cancer

Status Withdrawn

Clinical Trial Summary

This pilot clinical trial studies the side effects and how well stereotactic radiosurgery followed by wedge resection works in treating patients with early stage non-small cell lung cancer that is located in the outer, or peripheral, areas of the lung. Stereotactic radiosurgery, also known as stereotactic body radiation therapy, is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Wedge resection is a less invasive type of surgery for removal of the tumor and a small amount of normal tissue around it. Giving stereotactic radiosurgery followed by wedge resection may be a safe treatment option for patients who cannot receive standard treatment with lobectomy.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To assess the safety and feasibility of a wedge resection following stereotactic body radiation therapy (SBRT) for early stage peripheral non-small cell lung cancer (NSCLC).

SECONDARY OBJECTIVES:

I. To assess pathologic response rates to SBRT as determined by pathologic examination of resected tumors.

II. To prospectively assess patient quality of life when treated with SBRT and wedge resection.

TERTIARY OBJECTIVES:

I. To describe the location of viable tumor and to correlate pathologic response rates with radiation dose, size of tumor, and tumor histology.

II. To correlate pathologic response rates and functional imaging with pre- and post-treatment dual-input perfusion (DP)-computed tomography (CT) and positron emission tomography (PET)-CT.

III. To correlate changes in serum levels of deoxyribonucleic acid (DNA) methylation and circulating tumor cells (CTC) with pathologic response rates.

OUTLINE:

Patients undergo stereotactic radiosurgery every other day for 3 or 5 fractions (depending on the size tumor and proximity to the chest wall). Within 4-6 weeks after completion of stereotactic radiosurgery, patients undergo wedge resection.

After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Recurrent Non-small Cell Lung Cancer
• Stage IA Non-small Cell Lung Cancer
• Stage IB Non-small Cell Lung Cancer

• NCT number: NCT02250378
• Study type: Interventional
• Source: University of Southern California
• Status: Withdrawn
• Phase: N/A
• Start date: October 2014
• Completion date: September 2015