Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
Please note the ANZCTR will be unattended on Monday the 7th of October for the Labour Day public holiday.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12617000507381
Ethics application status
Approved
Date submitted
30/03/2017
Date registered
7/04/2017
Date last updated
29/06/2021
Date data sharing statement 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)
Query!
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.
Query!
Secondary ID [1]
291580
0
MASC 01.07 SS01.13 The Hair Spare Study
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
HairSpare
Query!
Linked study record
This study is a sub-study of the 01.07 WBRTMel trial: ACTRN12607000512426
Query!
Health condition
Health condition(s) or problem(s) studied:
Brain metastases
302689
0
Query!
Melanoma
302690
0
Query!
Solid organ cancers
302691
0
Query!
Condition category
Condition code
Cancer
302204
302204
0
0
Query!
Any cancer
Query!
Cancer
302205
302205
0
0
Query!
Brain
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
297643
0
Treatment: Other
Query!
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.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
301620
0
Change in density of scalp hair, assessed by dermatologist using Cross Section Trichometry measurement (CTM).
Query!
Assessment method [1]
301620
0
Query!
Timepoint [1]
301620
0
4 weeks post treatment
Query!
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.
Query!
Assessment method [1]
333315
0
Query!
Timepoint [1]
333315
0
3 months post treatment
Query!
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.
Query!
Assessment method [2]
333316
0
Query!
Timepoint [2]
333316
0
3 months post treatment
Query!
Secondary outcome [3]
333317
0
In-brain overall progression free survival as assessed by routine MRI at 3 months post treatment.
Query!
Assessment method [3]
333317
0
Query!
Timepoint [3]
333317
0
3 months post treatment
Query!
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.
Query!
Assessment method [4]
333318
0
Query!
Timepoint [4]
333318
0
3 months post treatment
Query!
Secondary outcome [5]
333319
0
Overall survival
Query!
Assessment method [5]
333319
0
Query!
Timepoint [5]
333319
0
3 months post treatment
Query!
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
Query!
Assessment method [6]
333321
0
Query!
Timepoint [6]
333321
0
4 weeks and 3 months post treatment
Query!
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)
Query!
Assessment method [7]
333322
0
Query!
Timepoint [7]
333322
0
4 week and 3 months post treatment
Query!
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.
Query!
Assessment method [8]
333324
0
Query!
Timepoint [8]
333324
0
4 weeks and 3 months post treatment
Query!
Secondary outcome [9]
333325
0
Presence of follicular ostia (to determine permanency of alopecia) by dermatologist
Query!
Assessment method [9]
333325
0
Query!
Timepoint [9]
333325
0
3 months post treatment
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
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.
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
3/03/2017
Query!
Date of last participant enrolment
Anticipated
3/09/2018
Query!
Actual
23/07/2018
Query!
Date of last data collection
Anticipated
20/12/2018
Query!
Actual
23/10/2018
Query!
Sample size
Target
15
Query!
Accrual to date
Query!
Final
9
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
7747
0
Mater Sydney - North Sydney
Query!
Recruitment postcode(s) [1]
15676
0
2060 - North Sydney
Query!
Funding & Sponsors
Funding source category [1]
296068
0
Other Collaborative groups
Query!
Name [1]
296068
0
Melanoma and Skin Cancer (MASC) Trials
Query!
Address [1]
296068
0
level 2, 553 St Kilda Road, Melbourne, Victoria 3004
Query!
Country [1]
296068
0
Australia
Query!
Primary sponsor type
Other Collaborative groups
Query!
Name
Melanoma and Skin Cancer (MASC) Trials
Query!
Address
level 2, 553 St Kilda Road, Melbourne, Victoria 3004
Query!
Country
Australia
Query!
Secondary sponsor category [1]
294961
0
None
Query!
Name [1]
294961
0
Query!
Address [1]
294961
0
Query!
Country [1]
294961
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
297324
0
Sydney Local Health District Research Ethics and Governance Office
Query!
Ethics committee address [1]
297324
0
Research Development Office Royal Prince Alfred Hospital Missenden Road CAMPERDOWN NSW 2050
Query!
Ethics committee country [1]
297324
0
Australia
Query!
Date submitted for ethics approval [1]
297324
0
14/11/2016
Query!
Approval date [1]
297324
0
23/12/2016
Query!
Ethics approval number [1]
297324
0
X16-0388 & HREC/16/RPAH/553
Query!
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.
Query!
Trial website
masc.org.au/completed-and-published-trials/
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
73710
0
Prof Gerald Fogarty
Query!
Address
73710
0
Mater Sydney Hospital
25 Rocklands Rd
North Sydney NSW 2060
Query!
Country
73710
0
Australia
Query!
Phone
73710
0
+61 2 94588050
Query!
Fax
73710
0
Query!
Email
73710
0
gerald.fogarty@cancer.com.au
Query!
Contact person for public queries
Name
73711
0
Aileen Boyd-Squires
Query!
Address
73711
0
level 2, 553 St Kilda Road, Melbourne, Victoria 3004
Query!
Country
73711
0
Australia
Query!
Phone
73711
0
+61 3 9903 9022
Query!
Fax
73711
0
Query!
Email
73711
0
hello@masc.org.au
Query!
Contact person for scientific queries
Name
73712
0
Gerald Fogarty
Query!
Address
73712
0
Mater Sydney Hospital
25 Rocklands Rd
North Sydney NSW 2060
Query!
Country
73712
0
Australia
Query!
Phone
73712
0
+61 2 94588050
Query!
Fax
73712
0
Query!
Email
73712
0
gerald.fogarty@cancer.com.au
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF