NCT00643318

CyberKnife Radiosurgical Treatment of Inoperable Early Stage Non-Small Cell Lung Cancer

A Prospective Evaluation of Outcomes of Radiosurgical Treatment of Early Stage Non-Small Cell Lung Cancer (NSCLC)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Accuray Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the short and long-term outcomes after CyberKnife stereotactic radiosurgery for early stage non-small cell lung cancer (NSCLC) in patients who are medically inoperable.

Detailed description

The objectives of this clinical evaluation are to assess the outcomes of patients who undergo stereotactic radiosurgery (SRS) to treat primary early stage non-small cell lung cancer (NSCLC) in patients (comprising of two cohorts, peripheral and central) who are not candidates for surgical resection because of high operative risks. In particular, the effect of CyberKnife SRS on clinical response rate, local control, progression-free survival, overall survival, dyspnea and QOL (for U.S. sites), and radiological findings over two years after treatment will be evaluated.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	CyberKnife Stereotactic Radiosurgery	Central tumors defined as \< 2 cm from carina and \< 2 cm from right and left mainstem bronchus and/or \< 2 cms from the right and left upper lobe bronchus, bronchus intermedius, middle lobe bronchus, and the right and left lower lobe bronchus. For central tumors, 4 fractions of 12 Gy will be delivered (12 Gy x 4 fractions = 48 Gy) Peripheral tumors are defined as being \> 2 cms from the carina and \> 2 cms from the right and left mainstem bronchus and/or \> 2 cms from the right and left upper lobe bronchus, bronchus intermedius, middle lobe bronchus and the right and left lower lobe bronchus. For peripheral tumors, 3 fractions of 20 Gy will be delivered (20 Gy x 3 fractions = 60 Gy)

Timeline

• Start date: 2006-04-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2008-03-26
• Last updated: 2021-03-05

Locations

23 sites across 2 countries: United States, China