AzTrials
AzTrials

Metastatic MelanomaWBRTMelNCT01503827

Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma

A study testing WBRT in people with Metastatic Melanoma, run by Melanoma and Skin Cancer Trials Limited at 23 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Melanoma
What is being tested?
WBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
23 sitesin 3 countries
Study dates
Oct 2007to Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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;
Show all 9Show fewer
  • 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

Trial locations and contacts

23 sites in 3 countries.

23 sites in 3 countries

Australia17 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • St Vincent's Hospital

    Darlinghurst, New South Wales, 2010

  • Darwin Hospital, NT Radiation Oncology

    Darwin, Northern Territory

  • Peter MacCallum Cancer Centre

    East Melbourne, Victoria, 8006

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Calvary Mater Hospital

    Newcastle, New South Wales, 2310

  • Genesis Cancer Care - Gateshead

    Newcastle, New South Wales

  • Melanoma Institute Australia / Royal Prince Alfred Hospital

    North Sydney, New South Wales, 2060

  • Nepean Hospital

    Penrith, New South Wales, 2751

  • Radiation Oncology Services - Mater Centre

    South Brisbane, Queensland, 4101

  • Townsville Hospital

    Townsville, Queensland, 4812

  • Genesis Cancer Care - Tugun

    Tugun, Queensland, 4224

  • Westmead Hospital

    Westmead, New South Wales

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

United Kingdom5 sites

  • Churchill Hospital

    Headington, Oxford, OX3 7LJ

  • St. James University Hospital

    Leeds, LS9 7TF

  • Mount Vernon Cancer Centre

    Northwood, Middlesex, HA6 2RN

  • Norfolk & Norwich University Hospital

    Norwich, NR4 7UY

  • Velindre Hospital

    Whitchurch, Cardiff, CF14 2TL

Other trials in United Kingdom

Norway1 site

  • The Norwegian Radium Hospital

    Oslo, 0310

Other trials in Norway

About this study

Official title: 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.

Being tested
WBRT
Keywords
Whole Brain Radiotherapy, Brain metastases, Melanoma, Stage IV Metastatic Melanoma, Neurocognitive function, Quality of life
Medical subject headings
Melanoma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WBRTRadiation

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

Study groups in NCT01503827
Study groupRoleWhat they receive
WBRTExperimentalPatients 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
Receives: Radiation: WBRT
ObservationNo interventionNo Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with distant intracranial failure as determined by magnetic resonance imaging (MRI) assessment

    Measured: 12 months post randomisation

Secondary outcomes (6)

  1. Time to intracranial failure (local, distant and overall) as determined by MRI

    Measured: Post randomisation to intracranial failure

  2. Quality of life as measured by EORTC QLQ-C30 and BN-20

    Measured: 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).

    Measured: At baseline and every 2 months post randomisation

  4. Overall survival

    Measured: Post randomisation to death from any cause

  5. Performance status as measured by ECOG

    Measured: At baseline and every 2 months post randomisation

  6. Incremental cost effectiveness ratio (ICER)

    Measured: At 12 months from randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2012 (estimated)
  2. Study startOct 2007
  3. Primary completionSep 2017
  4. Study completionJun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01503827
Sponsor's protocol ID
01-07
Other IDs
ACTRN12607000512426
Acronym
WBRTMel
Status last verified
Jan 2021
First submitted
15 Dec 2011
Last updated
7 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21496312

  • Bartula I, Tran AD, Nowak AK, Ahmed T, Morton RL, Burmeister BH, Dolven-Jacobsen K, Nobes J, Thompson JF, Fogarty GB, Lo SN, Hong AM. Longitudinal trajectory of quality of life for patients with melanoma brain metastases: A secondary analysis from a whole brain radiotherapy randomized clinical trial. Clin Transl Radiat Oncol. 2023 Feb 15;41:100597. doi: 10.1016/j.ctro.2023.100597. eCollection 2023 Jul.

    PubMed 37441544

  • Hong AM, Fogarty GB, Dolven-Jacobsen K, Burmeister BH, Lo SN, Haydu LE, Vardy JL, Nowak AK, Dhillon HM, Ahmed T, Shivalingam B, Long GV, Menzies AM, Hruby G, Drummond KJ, Mandel C, Middleton MR, Reisse CH, Paton EJ, Steel V, Williams NC, Scolyer RA, Morton RL, Thompson JF. Adjuvant Whole-Brain Radiation Therapy Compared With Observation After Local Treatment of Melanoma Brain Metastases: A Multicenter, Randomized Phase III Trial. J Clin Oncol. 2019 Nov 20;37(33):3132-3141. doi: 10.1200/JCO.19.01414. Epub 2019 Sep 25.

    PubMed 31553661

  • Lo SN, Hong AM, Haydu LE, Ahmed T, Paton EJ, Steel V, Hruby G, Tran A, Morton RL, Nowak AK, Vardy JL, Drummond KJ, Dhillon HM, Mandel C, Scolyer RA, Middleton MR, Burmeister BH, Thompson JF, Fogarty GB. Whole brain radiotherapy (WBRT) after local treatment of brain metastases in melanoma patients: Statistical Analysis Plan. Trials. 2019 Aug 5;20(1):477. doi: 10.1186/s13063-019-3555-5.

    PubMed 31382986

Questions about this trial

What is this clinical trial studying?

A study testing WBRT in people with Metastatic Melanoma, run by Melanoma and Skin Cancer Trials Limited at 23 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Australia, United Kingdom, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with distant intracranial failure as determined by magnetic resonance imaging (MRI) assessment (time frame: 12 months post randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01503827, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in