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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
Date last updated
7/01/2021

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
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. 220 people will be recruited from sites in Australia, Norway, the UK, the US and other international sites.
Trial website
https://clinicaltrials.gov/study/NCT01503827
Trial related presentations / publications
Fogarty G, Morton RL, Vardy J, Nowak AK, Mandel C, Forder PM, Hong A, Hruby G, Burmeister B, Shivalingam B, Dhillon H, Thompson JF. Whole brain radiotherapy after local treatment of brain metastases in melanoma patients--a randomised phase III trial. BMC Cancer. 2011 Apr 17;11:142. doi: 10.1186/1471-2407-11-142.
Hong AM, Fogarty GB, Dolven-Jacobsen K, Burmeister BH, Lo SN, Haydu LE, Vardy JL, Nowak AK, Dhillon HM, Ahmed T, Shivalingam B, Long GV, Menzies AM, Hruby G, Drummond KJ, Mandel C, Middleton MR, Reisse CH, Paton EJ, Steel V, Williams NC, Scolyer RA, Morton RL, Thompson JF. Adjuvant Whole-Brain Radiation Therapy Compared With Observation After Local Treatment of Melanoma Brain Metastases: A Multicenter, Randomized Phase III Trial. J Clin Oncol. 2019 Nov 20;37(33):3132-3141. doi: 10.1200/JCO.19.01414. Epub 2019 Sep 25.
Lo SN, Hong AM, Haydu LE, Ahmed T, Paton EJ, Steel V, Hruby G, Tran A, Morton RL, Nowak AK, Vardy JL, Drummond KJ, Dhillon HM, Mandel C, Scolyer RA, Middleton MR, Burmeister BH, Thompson JF, Fogarty GB. Whole brain radiotherapy (WBRT) after local treatment of brain metastases in melanoma patients: Statistical Analysis Plan. Trials. 2019 Aug 5;20(1):477. doi: 10.1186/s13063-019-3555-5.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01503827