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Trial registered on ANZCTR


Registration number
ACTRN12617000507381
Ethics application status
Approved
Date submitted
30/03/2017
Date registered
7/04/2017
Date last updated
31/10/2018
Date data sharing statement initially provided
31/10/2018
Date results information initially provided
31/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A feasibility study of hair sparing whole brain radiotherapy with volumetric modulated arc therapy for patients who have brain metastases from any malignancy. (The Hair Spare Study)
Scientific title
A feasibility study of hair sparing whole brain radiotherapy with volumetric modulated arc therapy for patients who have brain metastases from any malignancy.
Secondary ID [1] 291580 0
ANZMTG 01.07 SS01.13 The Hair Spare Study
Universal Trial Number (UTN)
Trial acronym
ANZMTG 01.07 SS01.13 The Hair Spare Study
Linked study record
This study is a sub-study of the ANZMTG 01.07 WBRTMel trial: ACTRN12607000512426

Health condition
Health condition(s) or problem(s) studied:
Brain metastases 302689 0
Melanoma 302690 0
Solid organ cancers 302691 0
Condition category
Condition code
Cancer 302204 302204 0 0
Any cancer
Cancer 302205 302205 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 297643 0
Treatment: Other
Comparator / control treatment
Two bald patients will make up the control group. Two bald control patients who require whole brain radiotherapy for brain metastases will receive hair sparing whole brain radiotherapy with volumetric modulated arc therapy as per the intervention group at the Radiation Oncology Department at Mater Sydney Hospital. Control patients will undergo radiotherapy planning, simulation and contouring, conducted by experienced radiation planners and oncologists. Control 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. Thermo Luminescent Dosimetry (TLDs) will be placed on skin surfaces within the field in first week, to validate the dose to scalp with this technique.
Control group
Active

Outcomes
Primary outcome [1] 301620 0
Change in density of scalp hair, assessed by dermatologist using Cross Section Trichometry measurement (CTM).

Timepoint [1] 301620 0
4 weeks post treatment
Secondary outcome [1] 333315 0
In-brain local progression free survival (in known brain metastases (BMs) or surgical cavities following surgery for BMs) as assessed by routine MRI at 3 months post treatment.
Timepoint [1] 333315 0
3 months post treatment
Secondary outcome [2] 333316 0
In-brain distant progression free survival – defined as new BMs 1cm from previous, or new leptomeningeal disease as assessed by routine MRI at 3 months post treatment.
Timepoint [2] 333316 0
3 months post treatment
Secondary outcome [3] 333317 0
In-brain overall progression free survival as assessed by routine MRI at 3 months post treatment.
Timepoint [3] 333317 0
3 months post treatment
Secondary outcome [4] 333318 0
Efficacy of HSWBRT in preventing distant in-brain recurrence especially leptomeningeal disease as assessed by routine MRI at 3 months post treatment.
Timepoint [4] 333318 0
3 months post treatment
Secondary outcome [5] 333319 0
Overall survival
Timepoint [5] 333319 0
3 months post treatment
Secondary outcome [6] 333321 0
Patient perception of hair shedding e.g. record of hair loss, need for hiding scalp e.g. wig, scarf, behaviours etc. as assessed by interview
Timepoint [6] 333321 0
4 weeks and 3 months post treatment
Secondary outcome [7] 333322 0
Impact of HSWBRT on quality of life, measured using a visual analogue scale, EORTC QLQ-C15-PAL+4 and Chemotherapy Induced Alopecia Distress Scale (CADS)
Timepoint [7] 333322 0
4 week and 3 months post treatment
Secondary outcome [8] 333324 0
Independent global assessment of cosmesis – via photography with a review by a physician, nurse and lay person occurring at the end of the study by a panel review.
Timepoint [8] 333324 0
4 weeks and 3 months post treatment
Secondary outcome [9] 333325 0
Presence of follicular ostia (to determine permanency of alopecia) by dermatologist
Timepoint [9] 333325 0
3 months post treatment

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Fifteen (15) patients will be involved in this feasibility study. Ten patients will be assessed by the clinician to have hair worth saving and will be placed on the full protocol. Two additional patients, who are bald by nature or from previous treatment, will be asked to be involved in a dosimetric study.
The QOL endpoint of role function has been shown to deteriorate at tumour progression and a change of 10 points is considered clinically significant. Time-to-event data will be compared between study arms using the log-rank test with a p-value of 0.05 considered significant to allow for multiple comparisons. Mean change scores and effect sizes will also be calculated from baseline to each assessment time point for relevant domains/items after formulation of a priori hypotheses by investigators with clinical or HRQL expertise, and will be compared between arms.
For the purpose of the analysis of time to deterioration in QOL, death or withdrawal from the QOL study due to inability to complete the assessments will be considered an event (i.e., deterioration in QOL) for all the QOL endpoints. Patients who do not deteriorate and remain alive or are lost to follow-up will be censored at the date of last contact.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7747 0
Mater Sydney - North Sydney
Recruitment postcode(s) [1] 15676 0
2060 - North Sydney

Funding & Sponsors
Funding source category [1] 296068 0
Other Collaborative groups
Name [1] 296068 0
Australia and New Zealand Melanoma Trials Group (ANZMTG)
Address [1] 296068 0
The Poche Centre
40 Rocklands Rd
North Sydney NSW 2060
Country [1] 296068 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australia and New Zealand Melanoma Trials Group (ANZMTG)
Address
The Poche Centre
40 Rocklands Rd
North Sydney NSW 2060
Country
Australia
Secondary sponsor category [1] 294961 0
None
Name [1] 294961 0
Address [1] 294961 0
Country [1] 294961 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297324 0
Sydney Local Health District Research Ethics and Governance Office
Ethics committee address [1] 297324 0
Research Development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 297324 0
Australia
Date submitted for ethics approval [1] 297324 0
14/11/2016
Approval date [1] 297324 0
23/12/2016
Ethics approval number [1] 297324 0
X16-0388 & HREC/16/RPAH/553

Summary
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.
Trial website
https://anzmtg.org/trialdetails.aspx?trialno=18
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73710 0
Prof Gerald Fogarty
Address 73710 0
Mater Sydney Hospital
25 Rocklands Rd
North Sydney NSW 2060
Country 73710 0
Australia
Phone 73710 0
+61 2 94588050
Fax 73710 0
Email 73710 0
gerald.fogarty@cancer.com.au
Contact person for public queries
Name 73711 0
Mrs Narelle Williams
Address 73711 0
Australia and New Zealand Melanoma Trials Group (ANZMTG)
The Poche Centre
40 Rocklands Rd
North Sydney NSW 2060
Country 73711 0
Australia
Phone 73711 0
+61 2 9911 7322
Fax 73711 0
Email 73711 0
narelle.williams@melanoma.org.au
Contact person for scientific queries
Name 73712 0
Prof Gerald Fogarty
Address 73712 0
Mater Sydney Hospital
25 Rocklands Rd
North Sydney NSW 2060
Country 73712 0
Australia
Phone 73712 0
+61 2 94588050
Fax 73712 0
Email 73712 0
gerald.fogarty@cancer.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary