Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma

Metastatic Melanoma Clinical Trial

— WBRTMel  

Official title:

Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma - A Randomised Phase III Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01503827
• Other study ID #: 01-07
• Secondary ID: ACTRN12607000512
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2007
• Est. completion date: June 2022

Study information

• Verified date: January 2021
• Source: Melanoma and Skin Cancer Trials Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: June 2022
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma
• Neoplasm Metastasis

Intervention

Radiation:
• WBRT
A minimum of 30 Gy in 10 fractions given as one fraction per day within 4 weeks of randomisation

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	St Vincent's Hospital	Darlinghurst	New South Wales
Australia	Darwin Hospital, NT Radiation Oncology	Darwin	Northern Territory
Australia	Peter MacCallum Cancer Centre	East Melbourne	Victoria
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Calvary Mater Hospital	Newcastle	New South Wales
Australia	Genesis Cancer Care - Gateshead	Newcastle	New South Wales
Australia	Melanoma Institute Australia / Royal Prince Alfred Hospital	North Sydney	New South Wales
Australia	Nepean Hospital	Penrith	New South Wales
Australia	Radiation Oncology Services - Mater Centre	South Brisbane	Queensland
Australia	Townsville Hospital	Townsville	Queensland
Australia	Genesis Cancer Care - Tugun	Tugun	Queensland
Australia	Westmead Hospital	Westmead	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Norway	The Norwegian Radium Hospital	Oslo
United Kingdom	Churchill Hospital	Headington	Oxford
United Kingdom	St. James University Hospital	Leeds
United Kingdom	Mount Vernon Cancer Centre	Northwood	Middlesex
United Kingdom	Norfolk & Norwich University Hospital	Norwich
United Kingdom	Velindre Hospital	Whitchurch	Cardiff

Sponsors (3)

Lead Sponsor	Collaborator
Melanoma and Skin Cancer Trials Limited	Trans Tasman Radiation Oncology Group, University of Oxford

Countries where clinical trial is conducted

Australia,  Norway,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with distant intracranial failure as determined by magnetic resonance imaging (MRI) assessment		12 months post randomisation
Secondary	Time to intracranial failure (local, distant and overall) as determined by MRI		Post randomisation to intracranial failure
Secondary	Quality of life as measured by EORTC QLQ-C30 and BN-20		At baseline and every 2 months post randomisation
Secondary	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).		At baseline and every 2 months post randomisation
Secondary	Overall survival		Post randomisation to death from any cause
Secondary	Performance status as measured by ECOG		At baseline and every 2 months post randomisation
Secondary	Incremental cost effectiveness ratio (ICER)		At 12 months from randomisation

External Links

•   Click here for more information about this study: Whole Brain Radiotherapy following local treatment of intracranial metastases of melanoma