Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma



Status:Recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2007
End Date:June 2021
Contact:Victoria Steel
Email:victoria.steel@melanoma.org.au
Phone:+61 2 9911 7386

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


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
We found this trial at
2
sites
500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Principal Investigator: Rogerio Neves, MD
Phone: 717-531-0003
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Darlinghurst, New South Wales 2010
Principal Investigator: Gerald Fogarty
Phone: +61 2 9355 5618
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Darlinghurst,
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