Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma

Not Applicable

• Conditions: Metastatic Melanoma
• Interventions: Radiation: WBRT

• Registration Number: NCT01503827
• Lead Sponsor: Melanoma and Skin Cancer Trials Limited

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2011-12-15
• Study First Submitted QC: 2012-01-02
• Study First Posted: 2012-01-04
• Primary Completion: 2017-09
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-06
• Last Update Posted: 2021-01-07
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WBRT	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

Primary Outcome Measures

Name	Time	Method
Proportion of patients with distant intracranial failure as determined by magnetic resonance imaging (MRI) assessment	12 months post randomisation

Secondary Outcome Measures

Name	Time	Method
Quality of life as measured by EORTC QLQ-C30 and BN-20	At baseline and every 2 months post randomisation
Time to intracranial failure (local, distant and overall) as determined by MRI	Post randomisation to intracranial failure
Overall survival	Post randomisation to death from any cause
Performance status as measured by ECOG	At baseline and every 2 months post randomisation
Incremental cost effectiveness ratio (ICER)	At 12 months from randomisation
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

Trial Locations

Locations (23)

St Vincent's Hospital; 🇦🇺 Darlinghurst, New South Wales, Australia

Royal Brisbane and Women's Hospital; 🇦🇺 Herston, Queensland, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, 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

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia

Radiation Oncology Services - Mater Centre; 🇦🇺 South Brisbane, Queensland, Australia

Darwin Hospital, NT Radiation Oncology; 🇦🇺 Darwin, Northern Territory, Australia

Townsville Hospital; 🇦🇺 Townsville, Queensland, Australia

Genesis Cancer Care - Tugun; 🇦🇺 Tugun, Queensland, Australia

Princess Alexandra Hospital; 🇦🇺 Woolloongabba, Queensland, Australia

Royal Hobart Hospital; 🇦🇺 Hobart, Tasmania, Australia

Peter MacCallum Cancer Centre; 🇦🇺 East Melbourne, Victoria, Australia

Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Sir Charles Gairdner Hospital; 🇦🇺 Nedlands, Western Australia, Australia

The Norwegian Radium Hospital; 🇳🇴 Oslo, Norway

Velindre Hospital; 🇬🇧 Whitchurch, Cardiff, United Kingdom

Mount Vernon Cancer Centre; 🇬🇧 Northwood, Middlesex, United Kingdom

Churchill Hospital; 🇬🇧 Headington, Oxford, United Kingdom

Norfolk & Norwich University Hospital; 🇬🇧 Norwich, United Kingdom

St. James University Hospital; 🇬🇧 Leeds, United Kingdom

Calvary Mater Hospital; 🇦🇺 Newcastle, New South Wales, Australia