A Phase II Study of Whole Brain Radiotherapy With Simultaneous Integrated Boost Using Volumetric Modulated Arc Therapy for One to Ten Brain Metastases
This is a Phase II prospective clinical trial. Following registration, patients will be
required to undertake a baseline questionnaire assessment of daily living activities using
the Modified Barthel's index, as well as cognitive assessment using MMSE.
Patients will undergo MRI scan of the brain for radiotherapy planning purposes. During
radiotherapy planning and for each of the five radiotherapy fractions, patients will be
immobilised in a custom fitted stereotactic mask system, to minimise head movement. During
treatment, patients will have daily online setup corrections to ensure treatment accuracy.
Patients will be treated with WBRT/SIB using VMAT, delivering a total of 20 Gy in 5
fractions to the whole brain and 50Gy in 5 fractions to the brain metastases, delivered once
daily on working days. Anti-nausea and anti-inflammatory medication will be prescribed to
minimise acute toxicity.
Following therapy completion, patients will be seen every 3 months for the 1st year, then
every 6 months thereafter. At each clinic visit, clinicians or study investigators will
monitor for toxicity from therapy, document neurologic symptoms and signs and performance
status as well as Modified Barthel's index and cognitive assessment.
Patients will have contrast-enhanced MRI brain at 3 months and 1 year, and contrast-enhanced
CT brain at 6 months and 9 months in the first year and every 6 months after the first year.
Serum creatinine levels will be done prior to each scan to ensure safety of intravenous
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
3 month treatment response of metastases evaluated using contrast-enhanced MRI scan of brain
3 months post treatment
Alan Nichol, MD
British Columbia Cancer Agency
Canada: Health Canada