None listed
Conditions
Brief summary
This pilot study will gather preliminary data on the impact of Hippocampal Avoidance Technique for Whole Brain Radiotherapy on cognition and clinical feasibility for the treatment of brain metastases in patients with breast cancer Who is it for? You may be eligible to join this study if you are aged 18 years or above, have pathologically proven diagnosis of breast cancer stage IV disease with brain metastases which are outside of a 5 mm margin around either hippocampus Study details Whole brain radiotherapy (WBRT) is effective in providing local control of brain metastases and thereby preserving overall neurocognitive function as well as quality of life. Unfortunately, an adverse effect of WBRT is an often rapid decline in certain neurocognitive functions, particularly memory. This has been correlated with radiation induced injury thought to be crucial to memory formation. The planning of the treatment encompass the whole brain excluding the hippocampal avoidance regions, defined as the hippocampus with a 5 mm expansion. All participants will receive Whole Brain Radiotherapy using the Hippocampal Avoidance Technique of 10 radiotherapy sessions over a two-week period. The radiotherapy treatment will take approximately 5-10 minutes daily, however the total time in the department will be approximately an hour. Participants will be followed-up for up to 12 months after the completion of radiotherapy treatment in order to determine feasibility, safety, clinical benefit, survival rates and quality of life. Participants will also be asked to complete short verbal and written questionnaires to assess memory function and quality of life. These will be done before radiotherapy, on completion of radiotherapy and at follow-up appointments at 3, 6, 9 and 12 months. A CT scan and MRI scan of the head will be arranged prior to treatment, for the purpose of planning the radiotherapy. A follow-up brain MRI scan will be arranged at 3 months and 9 months after radiotherapy or when clinically indicated. This is consistent with current standard practice.
Interventions
Patients will be treated with volumetric modulated arc therapy at Perth Radiation Oncology Centre, WA. All treatment will be planned by Radiation Oncologists and treatment delivered by trained Radiation Therapists. Simulation and treatment will occur with the patient immobilised in a supine position using a head cast and custom headrest. The chin will be tucked to ensure the optical apparatus are not in the same plane as the hippocampus and reduce the impact of dental artefacts. For the purpose
Patients will be treated with volumetric modulated arc therapy at Perth Radiation Oncology Centre, WA. All treatment will be planned by Radiation Oncologists and treatment delivered by trained Radiation Therapists. Simulation and treatment will occur with the patient immobilised in a supine position using a head cast and custom headrest. The chin will be tucked to ensure the optical apparatus are not in the same plane as the hippocampus and reduce the impact of dental artefacts. For the purpose of treatment planning a non-contrast head CT with an axial slice thickness of 1 mm will be acquired. This will be fused with a contrast enhanced brain MRI scan to be done within 14 days of expected commencement of radiotherapy. If a baseline brain MRI has been done that is acceptable for planning purposes within 28 days of expected radiotherapy commencement then this may be utilised at the discretion of the treating radiation oncologist. . Prescribed dose will be 30 Gy in 10 fractions, to be delivered over 2 weeks, at 5 fractions per week and 3 Gy per fraction. Extension of treatment duration by up to 3 standard treatment days will be considered an acceptable deviation if unavoidable due to clinical or technical limitations that arise. Hippocampal dose limits will be D100% < 9 Gy and Dmax < 16 Gy. Deviations of D100% < 10 Gy and Dmax < 17 Gy will be considered acceptable. Deviations of D100% > 10 Gy and Dmax > 17 Gy will be considered unacceptable Hopkins Verbal Learning Test revised (HVLT) and the FACT-Br QoL will be utilised pre treatment and at visits 1 and 10 and then at 3, 6, 9 and 12 months post radiotherapy
Sponsors
Genesis Care
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Signed informed consent 2) Pathologically proven diagnosis of breast cancer 3) Stage IV disease with brain metastases which are outside of a 5 mm margin around either hippocampus 4) Stable or responsive extracranial disease as assessed by the patient’s medical oncologist 5) ECOG 0-2 6) Suitable for treatment with WBRT 7) Non-pregnant women aged over 18 years 8) Patients able to sufficiently cooperate with the proposed study requirements 9) Brain metastases that have previously been managed with surgical resection or stereotactic radiosurgery are permitted
Exclusion criteria
1) Life expectancy anticipated to be equal to or less than 12 weeks 2) Brain metastases within a 5mm margin of either hippocampus 3) Leptomeningeal disease 4) Pregnant women or women of child bearing age who do not wish to use contraception during radiotherapy treatment 5) Patients with significant psychological or psychiatric comorbidity 6) All cytotoxic chemotherapy must be withheld from 21 days before starting HAT WBRT, during HAT WBRT delivery and for 30 days after delivery of HAT WBRT
Outcome results
None listed