None listed
Conditions
Brief summary
The primary purpose of this trial is to evaluate the feasibility of conducting volumetric modulated arc therapy hair sparing whole brain radiotherapy (VMAT HSWBRT) in cancer patients with brain metastases. Who is it for? You may be eligible to enrol in this trial if you are aged 18 or over and have a solid tumour or melanoma with brain metastases, for which you require whole brain radiotherapy (WBRT). The trial will enrol thirteen (13) patients with stable scalp hair of at least 2.5cm in length and two patients who are bald. Study details Standard WBRT involves the scalp receiving the full dose of radiation, damaging hair follicles and often leading to alopecia, which decreases quality of life. VMAT HSWBRT may allow for the radiation to be delivered to the metastases whilst minimising the radiation received by the scalp. For all participants, the treatment will involve attending radiotherapy planning/simulation sessions. Patients are treated with VMAT HSWBRT 30Gy in 15 fractions, one fraction delivered at each daily session. Participants will also undergo follow up visits at 4 weeks and 3 months after treatment. It is hoped that if found to be feasible and effective, the use of VMAT HSWBRT could reduce symptoms of alopecia following WBRT for brain metastases and increase quality of life.
Interventions
Hair sparing whole brain radiotherapy with volumetric modulated arc therapy will be delivered to all participants for the study at the Radiation Oncology Department at Mater Sydney Hospital. All patients will undergo radiotherapy planning, simulation and contouring, conducted by experienced radiation planners and oncologists. All patients will be treated with whole brain radiotherapy 30 Gy in 15 fractions, given one fraction maximum per day. Volumetric modulated arc therapy (VMAT) will be deliv
Hair sparing whole brain radiotherapy with volumetric modulated arc therapy will be delivered to all participants for the study at the Radiation Oncology Department at Mater Sydney Hospital. All patients will undergo radiotherapy planning, simulation and contouring, conducted by experienced radiation planners and oncologists. All patients will be treated with whole brain radiotherapy 30 Gy in 15 fractions, given one fraction maximum per day. Volumetric modulated arc therapy (VMAT) will be delivered via arcs. The numbers of VMAT arcs used will be radiation planner dependent. Hippocampal avoidance (HA) may be attempted if clinically indicated, with a mean dose to hippocampus not exceeding 9 Gy and maximum dose of 14 Gy. Simultaneous integrated boost (SIB) to metastases of 45Gy in 15 fractions may also be added if clinically indicated.
Sponsors
Melanoma and Skin Cancer (MASC) Trials
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
Patients may be included in the study if they meet ALL of the following criteria: 1. Require WBRT for BMs from melanoma or any solid tumour. 2. Have stable scalp hair deemed worthy of conserving by both patient and physician. (not applicable for study controls) 3. Be able to assume the RT treatment position. 4. Life expectancy of at least 4 months 5. An ECOG performance status between of 0-2 at enrolment 6. Aged 18 years or older 7. Hair length of at least 2.5 cm at the measurement site to enable measurement with CTM (not applicable for study controls) 8. Able to provide written informed consent 9. Last cytotoxic chemotherapy at least 4 weeks prior to enrolment in study.
Exclusion criteria
Patients will be excluded from the study for ANY of the following reasons: 1. Previous WBRT 2. Leptomeningeal disease 3. Other cause of persisting alopecia including alopecia from previous cytotoxic chemotherapy; and male pattern baldness (female pattern baldness is acceptable). (Not applicable for study controls) 4. Planned concurrent cytotoxic chemotherapy within 4 weeks prior to RT or within 4 weeks after RT. 5. A medical or psychiatric condition that compromises ability to give informed consent or complete the protocol 6. Positive urine pregnancy test for women of childbearing potential (+/-7 days of inclusion onto the trial)
Outcome results
None listed