A Phase II Multi-institutional Study Assessing Simultaneous In-field Boost Helical Tomotherapy for 1-3 Brain Metastases
- Conditions
- Metastasis to Brain of Primary Cancer
- Interventions
- Radiation: Whole Brain XRT 30Gy/10 fractions with
- Registration Number
- NCT01543542
- Lead Sponsor
- Lawson Health Research Institute
- Brief Summary
Helical tomotherapy is a novel radiation treatment machine that combines two existing technologies: spiral radiotherapy 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 radiotherapy, 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
- Histological diagnosis of primary cancer
- Contrast enhanced MRI demonstrating 1-3 metastases within 6 weeks of enrollment
- Age greater than or equal to 18
- Karnofsky performance status greater than or equal to 70
- Patient available for subsequent follow-up appointments and testing as well as health-related quality of life questionnaires
- Anticipated survival (independent of the brain metastases) greater than 3 months
- Patient informed consent obtained
- Metastatic suitable for synchronous boost
- Extracranial disease controlled or to be treated
- Underlying medical condition precluding adequate follow-up
- Prior cranial radiotherapy
- Concurrent cytotoxic chemotherapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Radiation Therapy Treatment Whole Brain XRT 30Gy/10 fractions with Whole Brain XRT 30Gy/10 fractions with Simultaneous Infield Boost of Brain Lesions to 60Gy
- Primary Outcome Measures
Name Time Method Overall survival At approximately end of year 4 (study completion) Local disease control rate at 6 months At approximately 2.5 years CNS disease control rate at 6 months At approximately 2.5 years
- Secondary Outcome Measures
Name Time Method Assessment of RTOG versus RECIST versus Volumetric MRI criteria At approximately end of year 4 (study completion) Health related quality of life At approximately end of year 4 (study completion) Karnofsky performance status AT approximately end of year 4 (study completion) Mini mental status exam cognition At approximately end of year 4 (study completion) Acute toxicity At approximately end of year 4 (study completion) Late toxicity At approximately end of year 4 (study completion) Changes in MRI endpoints Measured at baseline, and 3 months and 6 months post-treatment Assessment in changes of diffusional weighted imaging and magnetic resonance spectroscopy. Changes at 3 months post-treatment and 6 months post-treatment will be compared to baseline (pre-treatment).
Trial Locations
- Locations (5)
Alberta Health Services, Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Centre Hospitalier De L'Universite de Montreal
🇨🇦Montreal, Quebec, Canada
McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
London Regional Cancer Program of the Lawson Health Research Institute
🇨🇦London, Ontario, Canada
The Ottawa Hospital Cancer Centre
🇨🇦Ottawa, Ontario, Canada