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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Australia and New Zealand Melanoma Trials Group
Sponsor:
Collaborators:
Trans-Tasman Radiation Oncology Group (TROG)
Sydney Neuro-Oncology Group
University of Oxford
Information provided by (Responsible Party):
Australia and New Zealand Melanoma Trials Group
ClinicalTrials.gov Identifier:
NCT01503827
First received: December 15, 2011
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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. 200 people will be recruited from sites in Australia, Norway, the UK, the US and other international sites.


Condition Intervention Phase
Metastatic Melanoma
Radiation: WBRT
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma - A Randomised Phase III Trial

Resource links provided by NLM:


Further study details as provided by Australia and New Zealand Melanoma Trials Group:

Primary Outcome Measures:
  • Proportion of patients with distant intracranial failure as determined by magnetic resonance imaging (MRI) assessment [ Time Frame: 12 months post randomisation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to intracranial failure (local, distant and overall) as determined by MRI [ Time Frame: Post randomisation to intracranial failure ] [ Designated as safety issue: No ]
  • Quality of life as measured by EORTC QLQ-C30 and BN-20 [ Time Frame: At baseline and every 2 months post randomisation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Post randomisation to death from any cause ] [ Designated as safety issue: No ]
  • Performance status as measured by ECOG [ Time Frame: At baseline and every 2 months post randomisation ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2007
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01503827

Contacts
Contact: Victoria Steel +61 2 9911 7386 victoria.steel@melanoma.org.au
Contact: Elizabeth Paton +61 2 9911 7354 elizabeth.paton@melanoma.org.au

Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Not yet recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Missy Crain    717-531-0003 ext 289630    mcrain@hmc.psu.edu   
Principal Investigator: Rogerio Neves, MD         
Australia, New South Wales
St Vincent's Hospital Recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: Dale Dalley    +61 2 9355 5618    daledalley@stvincents.com.au   
Principal Investigator: Gerald Fogarty         
Calvary Mater Hospital Recruiting
Newcastle, New South Wales, Australia, 2310
Contact: Sarah Gallagher    +61 2 4014 3947    Sarah.Gallagher@calvarymater.org.au   
Principal Investigator: Chris Wratten         
Melanoma Institute Australia / Royal Prince Alfred Hospital Recruiting
North Sydney, New South Wales, Australia, 2060
Contact: Maria Gonzalez    +61 2 9911 7200    maria.gonzalez@melanoma.org.au   
Principal Investigator: Angela Hong, MBBS, MMed, PhD         
Nepean Hospital Recruiting
Penrith, New South Wales, Australia, 2751
Contact: Clinical Trials Team    +61 2 4734 3500      
Principal Investigator: Wei Wang         
Westmead Hospital Recruiting
Westmead, New South Wales, Australia
Contact: Clinical Trials Team    +61 2 9845 5200      
Principal Investigator: Wei Wang         
Australia, Queensland
Royal Brisbane and Women's Hospital Recruiting
Herston, Queensland, Australia, 4029
Contact: Jennifer Edmunds    +61 7 3646 3465    Jennifer_Edmunds@health.qld.gov.au   
Principal Investigator: Michael Fay         
Radiation Oncology Services - Mater Centre Recruiting
South Brisbane, Queensland, Australia, 4101
Contact: Kacy Bauman    +61 7 3840 3219    Kacy_Baumann@health.qld.gov.au   
Principal Investigator: Andrew Pullar         
Townsville Hospital Recruiting
Townsville, Queensland, Australia, 4812
Contact: Wilna van der Watt    +61 7 4433 4281    TSV-Oncology-Clinical-Trials@health.qld.gov.au   
Principal Investigator: Sean Brennan         
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia, 4102
Contact: Jennifer Suffolk    +61 7 31767825    Jennifer_M_Suffolk@health.qld.gov.au   
Principal Investigator: Bryan Burmeister         
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Julie Butters    +61 8 8222 5024    julie.butters@health.sa.gov.au   
Principal Investigator: Daniel Roos         
Australia, Tasmania
Royal Hobart Hospital Recruiting
Hobart, Tasmania, Australia, 7000
Contact: Elizabeth Campbell-Taylor    +61 3 6222 7890    elizabeth.campbell-t@dhhs.tas.gov.au   
Principal Investigator: Raef Awad         
Australia, Victoria
Peter MacCallum Cancer Centre Recruiting
East Melbourne, Victoria, Australia, 8006
Contact: Jennifer Petersen    +61 3 9656 1111    trials.medonc2@petermac.org   
Principal Investigator: Vanessa Estall         
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Robin Smith    +61 3 9076 2360    robin.smith@wbrc.org.au   
Contact: Rachel Ward    +61 3 9076 2337    rachel.ward@alfred.org.au   
Principal Investigator: Jeremy Ruben         
Australia, Western Australia
Sir Charles Gairdner Hospital Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Mary-Anne Kedda    +61 8 9346 7923    Mary-Anne.Kedda@health.wa.gov.au   
Principal Investigator: Sean Bydder         
Norway
The Norwegian Radium Hospital Recruiting
Montebello, Oslo, Norway, 0310
Contact: Kari Dolven Jacobsen    +47 22934000    kari.dolven.jacobsen@radiumhospitalet.no   
Principal Investigator: Kari Dolven Jacobsen         
United Kingdom
Velindre Hospital Recruiting
Whitchurch, Cardiff, United Kingdom, CF14 2TL
Contact: Hana Wilbraham       hana.wilbraham@wales.nhs.uk   
Principal Investigator: Satish Kumar         
Mount Vernon Cancer Centre Recruiting
Northwood, Middlesex, United Kingdom, HA6 2RN
Contact: Sara Abbassi       sara.abbassi@nhs.net   
Principal Investigator: Carie Corner         
Churchill Hospital Recruiting
Headington, Oxford, United Kingdom, OX3 7LJ
Contact: Kathryn Room       earlyphasehub@oncology.ox.ac.uk   
Principal Investigator: Mark Middleton         
Clatterbridge Cancer Centre Withdrawn
Bebington, Wirral, United Kingdom, CH63 4JY
St. James University Hospital Recruiting
Leeds, United Kingdom, LS9 7TF
Contact: Tracey Rose       tracey.rose@leedsth.nhs.uk   
Principal Investigator: Maria Marples         
Norfolk & Norwich University Hospital Recruiting
Norwich, United Kingdom, NR4 7UY
Contact: Adele Cooper       adele.cooper@nnuh.nhs.uk   
Principal Investigator: Jenny Nobes         
Sponsors and Collaborators
Australia and New Zealand Melanoma Trials Group
Trans-Tasman Radiation Oncology Group (TROG)
Sydney Neuro-Oncology Group
University of Oxford
Investigators
Study Chair: Gerald Fogarty, BSc, MBBS Mater Hospital, St Vincent's Hospital, Melanoma Institue Australia
  More Information

Additional Information:
Publications:
Responsible Party: Australia and New Zealand Melanoma Trials Group
ClinicalTrials.gov Identifier: NCT01503827     History of Changes
Other Study ID Numbers: ANZMTG 01-07, ACTRN12607000512426
Study First Received: December 15, 2011
Last Updated: June 25, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Australia and New Zealand Melanoma Trials Group:
Whole Brain Radiotherapy
Brain metastases
Melanoma
Stage IV Metastatic Melanoma
Neurocognitive function
Quality of life

Additional relevant MeSH terms:
Melanoma
Nevi and Melanomas
Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014