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ANZMTG 01.07 SS01.13 - The Hair Spare Study

A feasibility study of hair sparing whole brain radiotherapy with volumetric modulated arc therapy for patients who have brain metastases from any malignancy.


Whole Brain Radiotherapy (WBRT) is a common palliative treatment for brain metastases (BMs). WBRT is traditionally given with opposed lateral fields. With this technique, the hair bearing scalp skin receives the full dose, resulting in acute epilation often leading to alopecia, so decreasing quality of life (QoL). VMAT HSWBRT is the acronym for volumetric modulated arc therapy hair sparing whole brain radiotherapy. VMAT may allow hair sparing (HS) when delivering WBRT. This study will investigate whether VMAT HSWBRT can minimise acute epilation while delivering effective WBRT, thereby improving QoL.


Study Objectives
To investigate whether VMAT HSWBRT can spare scalp hair at 4 weeks post WBRT as measured by cross-section trichometry (CTM) without compromising brain control at 3 months. 
Study Hypothesis
The primary hypothesis is that VMAT HSWBRT will spare scalp hair at 4 weeks post treatment according to measurement with dermatologist assessment in comparison with baseline using the CTM.
Study Design
This is a single institution feasibility study. All patients will be on the same treatment to assess the amount of hair sparing during radiotherapy. This is a sub-study of the ANZMTG 01.07 WBRTMel study - Whole Brain Radiotherapy following local treatment of intracranial metastases of melanoma, a randomised phase III trial.
Patient Accrual
The total patient accrual for this trial will be 12 patients (including 2 bald control patients) requiring WBRT for brain metastases from melanoma or any other solid tumour. Patients will be recruited through the Mater Sydney Hospital over 6 months.
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.
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 cross-section trichometer (CTM)
8. Able to provide written informed consent
9. Last cytotoxic chemotherapy at least 8 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
4. Planned concurrent cytotoxic chemotherapy within 8 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)
Study status - Open to recruitment
ANZ Clinical Trials Registry number identifier 

Principal Investigator's details:
Professor Gerald Fogarty
St Vincents Hospital and Mater Sydney Radiation Oncology

ANZMTG Project Officer details:
Narelle Williams
Phone: +61 2 9911 7322 

ANZMTG 01.07 WBRTMel SS01.13 Hair Spare study

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