A Phase II Study of Whole Brain Radiotherapy With Simultaneous Integrated Boost Using Volumetric Modulated Arc Therapy for One to Ten Brain Metastases
18 Years
N/A
Both
Brain Metastases
Trial Information
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
contrast administration.
Inclusion Criteria:
- Age ≥ 18
- pathologically confirmed solid malignancy diagnosed within the past 5 years (if the
original pathological cancer diagnosis is more than 5 years earlier, a biopsy to
confirm metastatic relapse within the past 5 years is required)
- 1-10 brain metastases
- Maximum diameter of largest metastasis ≤ 3 cm
- KPS ≥ 70
- Patient is neurologically stable with or without corticosteroids
- Extracranial disease well-controlled (6-month estimated median life expectancy).
- Available for regular clinical and imaging follow up
- Prior craniotomy permitted
Exclusion Criteria:
- Require craniotomy to relieve mass effect
- Previous cranial radiotherapy
- Metastatic germinoma, small cell carcinoma, multiple myeloma, lymphoma or leukaemia.
- Chemotherapy administered within one week before radiotherapy or planned within one
week after radiotherapy.
- Metastases within 0.7 cm of the optic chiasm, brainstem or optic nerves
- Brainstem metastases
- Systemic lupus erythematosis, scleroderma, or other connective tissue disorders not
in remission
- Multiple sclerosis
- Glomerular Filtration Rate < 60 ml/minute
- Non-small cell lung cancer with liver metastases
- Bilirubin > upper normal limit
- AST or ALT > 2X upper normal limit
- Pregnancy
- Summed volume of all metastasis PTVs > 50 cm3
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
3 month treatment response of metastases evaluated using contrast-enhanced MRI scan of brain
Outcome Time Frame:
3 months post treatment
Safety Issue:
No
Principal Investigator
Alan Nichol, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
British Columbia Cancer Agency
Authority:
Canada: Health Canada
Study ID:
WHAM!
NCT ID:
NCT01046123
Start Date:
January 2010
Completion Date:
January 2015
Related Keywords:
- Brain Metastases
- Neoplasm Metastasis
- Neoplasms, Second Primary
- Brain Neoplasms
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