Status:
COMPLETED
Whole Brain Radiotherapy Versus Volumetric Modulated Arc Therapy for Brain Metastases
Lead Sponsor:
British Columbia Cancer Agency
Conditions:
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients with brain metastases with expected life expectancy of 3-6 months are typically treated with radiotherapy to the whole brain giving a dose of 20 Gy over a 5 day period. This study will compar...
Detailed Description
This is a Phase II prospective clinical trial. Pre treatment evaluations include estimation of life expectancy, Creatinine (GFR) and MRI brain with contrast. An assessment of cognitive function using ...
Eligibility Criteria
Inclusion
- Age ≥ 18
- Pathologically confirmed solid malignancy
- 1-10 brain or brainstem metastases on MRI with a maximum of 4 cm diameter
- Documented extracranial disease
- Anticipated median survival 3-6 months (Graded Prognostic Assessment: Appendix I)
- Available for regular clinical and imaging follow up (\< 1 hour from a cancer centre)
- Montreal Cognitive Assessment score ≥ 20 (Appendix II)
- Karnofsky Performance Score (KPS) ≥ 70 (Appendix III)
- Barthel Activities of Daily Living score ≥ 90 (Appendix IV)
- Able to complete EORTC quality of life questionnaires (Appendix V)
Exclusion
- A metastasis located within 5 mm of the optic nerves or optic chiasm
- Requiring craniotomy to relieve mass effect
- Cytotoxic systemic therapy administered within one week before radiotherapy or planned within one week after radiotherapy
- Neurological decline since starting corticosteroids
- Metastatic germinoma, small cell carcinoma, multiple myeloma, lymphoma or leukaemia
- Systemic lupus erythematosis, scleroderma, or other connective tissue disorders not in remission
- Multiple sclerosis
- Glomerular Filtration Rate \< 45 ml/minute
- Contra-indications to MRI
- Pregnancy
- AST, ALT or Bilirubin \> 3 times upper limit of normal
- Haemorrhagic Metastases
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02220491
Start Date
October 1 2014
End Date
May 18 2020
Last Update
May 20 2020
Active Locations (1)
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1
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6