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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01503827




Registration number
NCT01503827
Ethics application status
Date submitted
15/12/2011
Date registered
4/01/2012

Titles & IDs
Public title
Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma
Scientific title
Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma - A Randomised Phase III Trial
Secondary ID [1] 0 0
ACTRN12607000512426
Secondary ID [2] 0 0
01-07
Universal Trial Number (UTN)
Trial acronym
WBRTMel
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - WBRT

Experimental: WBRT - Patients will receive WBRT after local treatment. A minimum of 30 Gy in 10 fractions given as one fraction per day within 4 weeks of randomisation

No intervention: Observation - No Intervention


Treatment: Other: WBRT
A minimum of 30 Gy in 10 fractions given as one fraction per day within 4 weeks of randomisation
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients with distant intracranial failure as determined by magnetic resonance imaging (MRI) assessment
Timepoint [1] 0 0
12 months post randomisation
Secondary outcome [1] 0 0
Time to intracranial failure (local, distant and overall) as determined by MRI
Timepoint [1] 0 0
Post randomisation to intracranial failure
Secondary outcome [2] 0 0
Quality of life as measured by EORTC QLQ-C30 and BN-20
Timepoint [2] 0 0
At baseline and every 2 months post randomisation
Secondary outcome [3] 0 0
Neurocognitive function as measured by Hopkins Verbal Learning Test, Controlled Oral Word Association Test, Trail Making Test Part A & B, Stroop - Colour and Word Test and Digit Span (Forwards and Backwards).
Timepoint [3] 0 0
At baseline and every 2 months post randomisation
Secondary outcome [4] 0 0
Overall survival
Timepoint [4] 0 0
Post randomisation to death from any cause
Secondary outcome [5] 0 0
Performance status as measured by ECOG
Timepoint [5] 0 0
At baseline and every 2 months post randomisation
Secondary outcome [6] 0 0
Incremental cost effectiveness ratio (ICER)
Timepoint [6] 0 0
At 12 months from randomisation

Eligibility
Key inclusion criteria
* 1-3 intracranial metastases on MRI from melanoma, locally treated with either surgical excision and/or stereotactic irradiation.
* Life expectancy of at least 6 months
* Aged 18 years or older
* WBRT must begin within 8 weeks of completion of localised treatment and within 4 weeks of randomisation
* 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
* Complete localised treatment of all these metastases no more than 6 weeks prior to randomisation
* An Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less at randomisation
* CT scan of chest, abdomen and pelvis as a minimum prior to randomisation. Scans must be within 12 weeks of randomisation
* Serum Lactate Dehydrogenase (LDH) must be = or < 2 x upper limit of normal
* Able to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any untreated intracranial disease
* Any previous intracranial treatment (surgical excision and/or stereotactic irradiation treatment and/or WBRT) prior to this diagnosis of intracranial melanoma
* Evidence of leptomeningeal disease on pre-local treatment MRI scan
* Patients with prior cancers, except:

* Those diagnosed more than five years ago with no evidence of disease recurrence within this time;
* Successfully treated basal cell and squamous cell skin carcinoma;
* Carcinoma in-situ of the cervix
* A medical or psychiatric condition that compromises ability to give informed consent or complete the protocol
* 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)
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
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2022
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Calvary Mater Hospital - Newcastle
Recruitment hospital [3] 0 0
Genesis Cancer Care - Gateshead - Newcastle
Recruitment hospital [4] 0 0
Melanoma Institute Australia / Royal Prince Alfred Hospital - North Sydney
Recruitment hospital [5] 0 0
Nepean Hospital - Penrith
Recruitment hospital [6] 0 0
Westmead Hospital - Westmead
Recruitment hospital [7] 0 0
Darwin Hospital, NT Radiation Oncology - Darwin
Recruitment hospital [8] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [9] 0 0
Radiation Oncology Services - Mater Centre - South Brisbane
Recruitment hospital [10] 0 0
Townsville Hospital - Townsville
Recruitment hospital [11] 0 0
Genesis Cancer Care - Tugun - Tugun
Recruitment hospital [12] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [13] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [14] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [15] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [16] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [17] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2310 - Newcastle
Recruitment postcode(s) [3] 0 0
- Newcastle
Recruitment postcode(s) [4] 0 0
2060 - North Sydney
Recruitment postcode(s) [5] 0 0
2751 - Penrith
Recruitment postcode(s) [6] 0 0
- Westmead
Recruitment postcode(s) [7] 0 0
- Darwin
Recruitment postcode(s) [8] 0 0
4029 - Herston
Recruitment postcode(s) [9] 0 0
4101 - South Brisbane
Recruitment postcode(s) [10] 0 0
4812 - Townsville
Recruitment postcode(s) [11] 0 0
4224 - Tugun
Recruitment postcode(s) [12] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [13] 0 0
5000 - Adelaide
Recruitment postcode(s) [14] 0 0
7000 - Hobart
Recruitment postcode(s) [15] 0 0
8006 - East Melbourne
Recruitment postcode(s) [16] 0 0
3004 - Melbourne
Recruitment postcode(s) [17] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Norway
State/province [1] 0 0
Oslo
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Cardiff
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Middlesex
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Oxford
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Leeds
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Norwich

Funding & Sponsors
Primary sponsor type
Other
Name
Melanoma and Skin Cancer Trials Limited
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Trans Tasman Radiation Oncology Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Oxford
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gerald Fogarty, BSc, MBBS
Address 0 0
Mater Hospital, St Vincent's Hospital, Melanoma Institue Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT01503827