An Outcome Analysis for Stereotactic Body Radiation Therapy (SBRT) Treatment of Non-Small Lung Cancer Patients Using 4D PET/CT With Real-Time Position Management (RPM™) System and a Concomitant Evaluation of the Impact and Performance Characteristics of the Immobilization System

Not Applicable

Terminated

• Conditions: Non Small Cell Lung Cancer; 4D CT
• Interventions: Radiation: Stereotactic Radiosurgery

• Registration Number: NCT02067858
• Lead Sponsor: Steven Burton

Brief Summary

The goals of this clinical research are to evaluate the outcomes and tumor response for early stage non-small lung cancer (NSCLC) patients undergoing Stereotactic Body Radiation Therapy (SBRT) using four dimensional (4D) Positron Emission Tomography (PET) and Computed Tomography (CT), Cone-Beam Computed Tomography (CBCT), Real-Time Position Management (RPM™) and body immobilization system (see figure 1). Specifically, the effect of image-guided SBRT treatment on clinical tumor response rate, local control and progression-free survival will be studied. This study will examine target volumes and relevant margins determined by an assessment using 4D PET and repeated 4D CT. These data will allow us to evaluate and determine the impact of the body immobilization system on the planning target volume (PTV) margins, patient's breathing pattern, target motion, and inter-treatment targets shifts.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2014-02-14
• Study First Submitted QC: 2014-02-18
• Study First Posted: 2014-02-20
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2017-12-04
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-20
• Last Update Submitted: 2018-06-20
• Results First Posted: 2018-07-18
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic Radiosurgery	Stereotactic Radiosurgery	3 fractions x 20 Gy 4 fractions x 12 Gy Lesion dependent

Primary Outcome Measures

Name	Time	Method
Assess Clinical Response Rate and Local Control Following SBRT Treatment of Patients With Early Stage NSCLC	2 years	The Number of Patients that completed SBRT

Secondary Outcome Measures

Name	Time	Method
Assess Progression-free Survival	2 years	Number of patients with Progression Free Survival at 2 Years

Trial Locations

Locations (1)

UPMC Shadyside Radiation Oncology Department; 🇺🇸 Pittsburgh, Pennsylvania, United States