An interventional study of whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapy in Brain Metastases, sponsored by British Columbia Cancer Agency. Active, not recruiting at 1 site in Canada. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by British Columbia Cancer Agency · Not applicable, Interventional, and Treatment
Radiotherapy to the whole brain is standard treatment for cancer that has spread to the brain (brain metastases) as it treats both the metastases that can be seen on scans and the brain metastases that are too small to be seen on scans.
This study will use a novel radiotherapy technique, called volumetric modulated arc therapy (VMAT), to treat patients with brain metastases. This technique allows delivery of both a standard radiation dose to the whole brain as well as a higher radiation dose to the brain metastases at the same time.
The study will assess the effectiveness of using VMAT in treating brain metastases, and examine its potential side-effects.
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 contrast administration.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's enrollment of 60 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →British Columbia Cancer Agency is the lead sponsor of 149 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapy
Radiation: whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapy
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.
3 month treatment response of metastases evaluated using contrast-enhanced MRI scan of brain
Time frame: 3 months post treatment
1-year local control of treated metastases evaluated with contrast-enhanced MRI scan of brain
Time frame: 1 year post-treatment
1-year brain control of metastases evaluated with contrast-enhanced MRI scan of brain
Time frame: 1 year post-treatment
Median survival
Time frame: No time frame
Both acute neurological toxicity (within 3 months of treatment) and late neurological toxicity (beyond 3 months of treatment
Time frame: 3 months and beyond
Time to decline in activities of daily living evaluated using the Modified Barthel index
Time frame: No time frame
Time to decline in cognition evaluated with the Mini-mental state examination
Time frame: No time frame
This study is active, not recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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British Columbia Cancer Agency