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

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ClinicalTrials.gov Identifier: NCT01503827
Recruitment Status : Active, not recruiting
First Posted : January 4, 2012
Last Update Posted : March 9, 2018
Sponsor:
Collaborators:
Trans-Tasman Radiation Oncology Group (TROG)
University of Oxford
Information provided by (Responsible Party):
Australia and New Zealand Melanoma Trials Group

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.

Condition or disease Intervention/treatment Phase
Metastatic Melanoma Radiation: WBRT Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma - A Randomised Phase III Trial
Study Start Date : October 2007
Actual Primary Completion Date : September 2017
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Proportion of patients with distant intracranial failure as determined by magnetic resonance imaging (MRI) assessment [ Time Frame: 12 months post randomisation ]

Secondary Outcome Measures :
  1. Time to intracranial failure (local, distant and overall) as determined by MRI [ Time Frame: Post randomisation to intracranial failure ]
  2. Quality of life as measured by EORTC QLQ-C30 and BN-20 [ Time Frame: At baseline and every 2 months post randomisation ]
  3. 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 ]
  4. Overall survival [ Time Frame: Post randomisation to death from any cause ]
  5. Performance status as measured by ECOG [ Time Frame: At baseline and every 2 months post randomisation ]
  6. Incremental cost effectiveness ratio (ICER) [ Time Frame: At 12 months from randomisation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503827


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

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 ( Registry Identifier: ANZCTR )
First Posted: January 4, 2012    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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