Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma (WBRTMel)

January 6, 2021 updated by: Melanoma and Skin Cancer Trials Limited

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St Vincent's Hospital
      • Newcastle, New South Wales, Australia, 2310
        • Calvary Mater Hospital
      • Newcastle, New South Wales, Australia
        • Genesis Cancer Care - Gateshead
      • North Sydney, New South Wales, Australia, 2060
        • Melanoma Institute Australia / Royal Prince Alfred Hospital
      • Penrith, New South Wales, Australia, 2751
        • Nepean Hospital
      • Westmead, New South Wales, Australia
        • Westmead Hospital
    • Northern Territory
      • Darwin, Northern Territory, Australia
        • Darwin Hospital, NT Radiation Oncology
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Women'S Hospital
      • South Brisbane, Queensland, Australia, 4101
        • Radiation Oncology Services - Mater Centre
      • Townsville, Queensland, Australia, 4812
        • Townsville Hospital
      • Tugun, Queensland, Australia, 4224
        • Genesis Cancer Care - Tugun
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
    • Victoria
      • East Melbourne, Victoria, Australia, 8006
        • Peter Maccallum Cancer Centre
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
  • Norway
      • Oslo, Norway, 0310
        • The Norwegian Radium Hospital
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • St. James University Hospital
      • Norwich, United Kingdom, NR4 7UY
        • Norfolk & Norwich University Hospital
    • Cardiff
      • Whitchurch, Cardiff, United Kingdom, CF14 2TL
        • Velindre Hospital
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre
    • Oxford
      • Headington, Oxford, United Kingdom, OX3 7LJ
        • Churchill Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Radiation: WBRT
A minimum of 30 Gy in 10 fractions given as one fraction per day within 4 weeks of randomisation
No Intervention: Observation
No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with distant intracranial failure as determined by magnetic resonance imaging (MRI) assessment
Time Frame: 12 months post randomisation
12 months post randomisation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Melanoma and Skin Cancer Trials Limited

Collaborators

University of Oxford
Trans Tasman Radiation Oncology Group

Investigators

  • Study Chair: Gerald Fogarty, BSc, MBBS, Mater Hospital, St Vincent's Hospital, Melanoma Institue Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

September 1, 2017

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

December 15, 2011

First Submitted That Met QC Criteria

January 2, 2012

First Posted (Estimate)

January 4, 2012

Study Record Updates

Last Update Posted (Actual)

January 7, 2021

Last Update Submitted That Met QC Criteria

January 6, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-07
  • ACTRN12607000512426 (Registry Identifier: ANZCTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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