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Trial registered on ANZCTR


Registration number
ACTRN12607000512426
Ethics application status
Approved
Date submitted
14/09/2007
Date registered
9/10/2007
Date last updated
5/03/2019
Date data sharing statement initially provided
5/03/2019
Date results information initially provided
5/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Whole Brain Radiotherapy following local treatment of melanoma brain metastases
Scientific title
Whole Brain Radiotherapy following local treatment of intracranial metastases of melanoma – A randomised phase III trial
Secondary ID [1] 466 0
ANZMTG 01-07
Universal Trial Number (UTN)
Trial acronym
WBRTMel
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma brain metastases 2335 0
Condition category
Condition code
Cancer 2438 2438 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Whole brain radiotherapy - a minimum of 30 Gy in 10 fractions given as one fraction per day within 4 weeks of randomisation
Intervention code [1] 2054 0
Treatment: Other
Comparator / control treatment
Observation of local and distant brain metastases by MRI, quality of life, ECOG performance status, neurocognitive function and survival until death or the end of the trial (12 months after the final patient is randomised).
Control group
Active

Outcomes
Primary outcome [1] 3338 0
Proportion of patients with distant intracranial failure as determined by magnetic resonance imaging (MRI) assessment
Timepoint [1] 3338 0
12 months post randomisation
Secondary outcome [1] 5552 0
Time to intracranial failure (local, distant and overall (local+ distant)) as determined by MRI
Timepoint [1] 5552 0
Post randomisation to intracranial failure
Secondary outcome [2] 5553 0
Quality of life as measured by EORTC QLQ-C30 and BN-20
Timepoint [2] 5553 0
At baseline and every 2 months post randomisation until distant intracranial failure, death or the end of the trial (12 months after the final patient is randomised).
Secondary outcome [3] 5554 0
Neurocognitive function as measured by Hopkins Verbal Learning Test, Controlled Oral Word Association Test, Trail Making Test Part A and B, Stroop - Colour and Word Test, Digit Span (Forwards and Backwards)
Timepoint [3] 5554 0
At baseline and every 2 months post randomisation until distant intracranial failure, death or the end of the trial (12 months after the final patient is randomised).
Secondary outcome [4] 5555 0
Overall survival
Timepoint [4] 5555 0
Post randomisation to death
Secondary outcome [5] 300535 0
Performance status as measured by ECOG
Timepoint [5] 300535 0
At baseline and every 2 months post randomisation until death or the end of the trial (12 months after the final patient is randomised).
Secondary outcome [6] 331916 0
Incremental cost-effectiveness ratio (ICER) reported in AUD per life year gained (LYG) and ICER per quality adjusted life year (QALY) gained.
Timepoint [6] 331916 0
12 months post randomisation of the final patient

Eligibility
Key inclusion criteria
1. 1-3 intracranial metastases on MRI from melanoma, locally treated with either surgical excision and/or stereotactic irradiation. 2. Life expectancy of at least 6 months 3. Aged 18 years or older 4. WBRT must be within 8 weeks of completion of localised treatment and within 4 weeks of randomisation 5. Able to have an MRI brain scan with contrast. ‘estimated Glomerular Filtrate Rate’ (eGFR) is adequate at the discretion of the radiologist and capable of having gadolinium-containing contrast medium for MRI as per practice guidelines 6. Complete localised treatment of all these metastases no more than 6 weeks prior to randomisation 7. An Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less at randomisation 8. CT scan of chest, abdomen and pelvis as a minimum prior to randomisation. Scans must be within 12 weeks of randomisation 9. Serum Lactate Dehydrogenase (LDH) must be = or < 2 x upper limit of normal 10. Able to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any untreated intracranial disease
2. Any previous intracranial treatment (surgical excision and/or stereotactic irradiation treatment and/or WBRT) prior to this diagnosis of intracranial melanoma
3. Evidence of leptomeningeal disease on pre-local treatment MRI scan
4. Patients with prior cancers, except:
o Those diagnosed more than five years ago with no evidence of disease recurrence within this time;
o Successfully treated basal cell and squamous cell skin carcinoma;
o Carcinoma in-situ of the cervix
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 within a week of registration onto the trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone using IVRS.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Minimisation will be used as the randomisation method for patients in this trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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,VIC,QLD,SA,WA
Recruitment hospital [1] 378 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 379 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 380 0
Westmead Hospital - Westmead
Recruitment hospital [4] 381 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [5] 382 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [6] 383 0
The Alfred - Prahran
Recruitment hospital [7] 384 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [8] 385 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [9] 386 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [10] 387 0
Nepean Hospital - Kingswood
Recruitment hospital [11] 388 0
The Townsville Hospital - Douglas
Recruitment hospital [12] 389 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [13] 390 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [14] 391 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [15] 7529 0
Genesis Cancer Care - Gateshead
Recruitment hospital [16] 7530 0
Genesis Cancer Care - Tugun - Tugun
Recruitment hospital [17] 7531 0
Royal Hobart Hospital - Hobart
Recruitment hospital [18] 7532 0
Royal Darwin Hospital - Tiwi
Recruitment postcode(s) [1] 436 0
2050
Recruitment postcode(s) [2] 6158 0
2065 - St Leonards
Recruitment postcode(s) [3] 6159 0
2145 - Westmead
Recruitment postcode(s) [4] 6160 0
2010 - Darlinghurst
Recruitment postcode(s) [5] 6161 0
2310 - Hunter Region
Recruitment postcode(s) [6] 6162 0
2751 - Penrith
Recruitment postcode(s) [7] 6163 0
8006 - Abeckett Street
Recruitment postcode(s) [8] 6164 0
3004 - Melbourne
Recruitment postcode(s) [9] 6165 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [10] 6166 0
4102 - Woolloongabba
Recruitment postcode(s) [11] 6167 0
4814 - Douglas
Recruitment postcode(s) [12] 6168 0
4101 - South Brisbane
Recruitment postcode(s) [13] 6169 0
5000 - Adelaide
Recruitment postcode(s) [14] 6170 0
6009 - Nedlands
Recruitment postcode(s) [15] 15354 0
2290 - Gateshead
Recruitment postcode(s) [16] 15355 0
4224 - Tugun
Recruitment postcode(s) [17] 15356 0
7000 - Hobart
Recruitment postcode(s) [18] 15357 0
0810 - Tiwi
Recruitment outside Australia
Country [1] 4777 0
Norway
State/province [1] 4777 0
Oslo, Trondheim
Country [2] 4778 0
United Kingdom
State/province [2] 4778 0
Oxford, Wirral, Norwich, Surrey, Leeds, Middlesex, Birmingham, Cardiff
Country [3] 4779 0
United States of America
State/province [3] 4779 0
Pennsylvania

Funding & Sponsors
Funding source category [1] 2630 0
Government body
Name [1] 2630 0
Cancer Australia
Address [1] 2630 0
PO BOX 1201
Dickson ACT 2602
Country [1] 2630 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australia and New Zealand Melanoma Trials Group (ANZMTG), University of Sydney
Address
The Poche Centre, 40 Rocklands Road, North Sydney NSW 2060
Country
Australia
Secondary sponsor category [1] 285312 0
None
Name [1] 285312 0
Address [1] 285312 0
Country [1] 285312 0
Other collaborator category [1] 43 0
Other Collaborative groups
Name [1] 43 0
SNOG (Sydney Neuro-Oncology Group)
Address [1] 43 0
Royal North Shore Hospital
St. Leonards
NSW
Country [1] 43 0
Australia
Other collaborator category [2] 277238 0
Other Collaborative groups
Name [2] 277238 0
Trans Tasman Radiation Oncology Group (TROG)
Address [2] 277238 0
Department of Radiation Oncology Newcastle Mater Hospital Locked Bag 7, Hunter Region Mail Centre NSW 2310
Country [2] 277238 0
Australia
Other collaborator category [3] 277239 0
University
Name [3] 277239 0
Oncology Clinical Trials Office (OCTO), University of Oxford
Address [3] 277239 0
Department of Clinical Oncology
University of Oxford
Old Road Campus Research Building
Roosevelt Drive
Headington
Oxford OX3 7DQ
Country [3] 277239 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4549 0
Cancer Institute NSW Clinical Research Ethics Committee
Ethics committee address [1] 4549 0
Level 9, 8 Central Avenue, Australian Technology Park, Eveleigh, NSW 2015
Ethics committee country [1] 4549 0
Australia
Date submitted for ethics approval [1] 4549 0
01/10/2007
Approval date [1] 4549 0
20/12/2007
Ethics approval number [1] 4549 0
Ethics committee name [2] 296997 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [2] 296997 0
c/- Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [2] 296997 0
Australia
Date submitted for ethics approval [2] 296997 0
09/12/2013
Approval date [2] 296997 0
05/02/2014
Ethics approval number [2] 296997 0
X13-0329 HREC/13/RPAH/465

Summary
Brief summary
People with brain metastases from melanoma are offered different treatment options after local treatment of their brain metastases via surgery or stereotactic irradiation. Depending on the treating institution and the clinician involved a patient may or may not be offered whole brain radiotherapy (WBRT) after their brain metastases are excised or treated with stereotactic irradiation. This trial seeks to determine if WBRT reduces the spread of brain metastases and lengthens the time to recurrence. The trial also examines the effect of WBRT on quality of life and brain functions such as memory, speech and concentration. Participants will be randomised after local treatment of their brain metastases to either WBRT or observation. 200 people will be recruited from sites in Australia, Norway, the UK, the US and other international sites.
Trial website
http://anzmtg.org/trialdetails.aspx?trialno=5
Trial related presentations / publications
Please contact ANZMTG for further information about presentations/publications.
Public notes

Contacts
Principal investigator
Name 28032 0
Prof Gerald Fogarty
Address 28032 0
Department of Radiation Oncology, Mater Hospital, Crows Nest NSW 2065
Country 28032 0
Australia
Phone 28032 0
+61 2 9458 8000
Fax 28032 0
Email 28032 0
Gerald.Fogarty@cancer.com.au
Contact person for public queries
Name 11189 0
Ms Elizabeth Paton
Address 11189 0
The Australia and New Zealand Melanoma Trials Group (ANZMTG), The Poche Centre, 40 Rocklands Rd, North Sydney NSW 2060
Country 11189 0
Australia
Phone 11189 0
+61 2 9911 7354
Fax 11189 0
+61 2 9954 9435
Email 11189 0
wbrt@melanoma.org.au
Contact person for scientific queries
Name 2117 0
Prof Gerald Fogarty
Address 2117 0
Department of Radiation Oncology, Mater Hospital, Crows Nest NSW 2065
Country 2117 0
Australia
Phone 2117 0
+61 2 9458 8000
Fax 2117 0
+61 2 9458 8088
Email 2117 0
Gerald.Fogarty@cancer.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be shared. identifying IPD is not collected in this trial.
What supporting documents are/will be available?
No other documents 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