A Phase II Multi-institutional Study Assessing Simultaneous In-field Boost Helical Tomotherapy for 1-3 Brain Metastases

Official Title

A Phase II Multi-institutional Study Assessing Simultaneous In-Field Boost Helical Tomotherapy for 1-3 Brain Metastases

Summary:

Helical tomotherapy is a novel radiation treatment machine that combines two existing technologies: spiral radiation therapy treatments combined with simultaneous computed tomotherapy imaging of the body. This new machine can potentially allow radiation treatments to be focused more precisely, and delivered more accurately than with existing radiation machines. In this study, helical tomotherapy will be used to provide radiation treatments (whole brain radiation therapy, daily over 10 treatments) that are commonly used to treat cancer metastatic to the brain. In addition, the individual spots of cancer (metastases) in the brain will be treated to a higher dose (approximately 2 times higher) than the dose to the whole brain. The purpose of this study is to determine the effectiveness of whole brain radiation with lesion boosting with the helical tomotherapy machine.

Trial Description

Primary Outcome:

• Overall survival
• Local disease control rate at 6 months
• CNS disease control rate at 6 months

• Assessment of RTOG versus RECIST versus Volumetric MRI criteria
• Health related quality of life
• Karnofsky performance status
• Mini mental status exam cognition
• Acute toxicity
• Late toxicity
• Changes in MRI endpoints

View this trial on ClinicalTrials.gov