Stereotactic Radiation Therapy (SBRT) of Lung Metastasis

Official Title

Lung Stereotactic Radiation Therapy for Patients With Non-small Cell Lung Cancer and Other Cancers

Summary:

The purpose of this institutional protocol is to offer SBRT to selected patients in a controlled environment to refine treatment techniques (including dose/fractionation schedules) and standardize follow-up. SBRT has been in clinical use for over a decade in some institutions and the available data suggest that it can be used safely and with good results. This study will see how effective Stereotactic Body Radiation Therapy is for treating tumours in the lung and how often people have side effects. Radiation therapy is usually given once a day, often for a few weeks. In this study, study participants will receive high doses of radiation treatment to tumours in the lung for 3 to 10 treatment sessions over a total of about 1 to 2 weeks. Several reports indicate that this therapy might shrink tumours and control the cancer for extended periods of time. Although specialists started to treat patients with SBRT over 10 years ago, it is still used in relatively few cancer centres.

Trial Description

Primary Outcome:

• Determine local control in patients treated with SBRT.
• Determine pattern of relapse in patients treated with SBRT.
• Determine survival rates in patients treated with SBRT.

Secondary Outcome:

• To characterize acute and late toxicity
• Assess the use of PET/CT in aiding target definition and predicting local response
• Assess the use of Cone Beam CT for precision imaging of the target and avoidance structures at each treatment
• Assess the use of 4D-computed tomography (CT) planning to determine Internal Treatment Volume (ITV) and Planning Treatment Volume (PTV)
• Develop organ motion prediction models
• Monitor major adverse cardiac events
• Monitor all-cause mortality
• Monitor cancer specific mortality

SBRT is an adaptation of the principles and experience gained from stereotactic brain RT. SBRT was developed in the early 90s at the Karolinska Institute in Stockholm, Sweden, and is used as an accepted alternative of treatment for patients with early stage lung cancer in many centres in Japan and a number of centres in Germany,USA and elsewhere. It is also now being used for patients who have lung metastases and extra-thoracic disease (primary or metastatic). Many reports indicate excellent local control (80-90% or higher) and minimal toxicity in well selected patients treated with thoracic SBRT. SBRT has traditionally had the following features: 1. High doses of radiation, usually in a few large fractions (it is "hypofractionated" compared with standard radiation therapy schedules) 2. Multiple radiation beams coming from different directions in the same plane ('co-planar' beams) as well as from different directions and different planes relative to the patient's body ('non-coplanar' beams) 3. Stereotactic beam placement, in that it is guided by a set of coordinates These coordinates are defined in relationship to the precise location of the tumour, determined from medical imaging (e.g. CT, MRI), rather than to a set of external marks (tattoos) or anatomical landmarks (such as bony structures)

View this trial on ClinicalTrials.gov