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Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma

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

NCT01503827•Melanoma and Skin Cancer Trials Limited

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (23)

St Vincent's Hospital

Darlinghurst, New South Wales, Australia

Calvary Mater Hospital

Newcastle, New South Wales, Australia

Genesis Cancer Care - Gateshead

Newcastle, New South Wales, Australia

Melanoma Institute Australia / Royal Prince Alfred Hospital

North Sydney, New South Wales, Australia

Nepean Hospital

Penrith, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Darwin Hospital, NT Radiation Oncology

Darwin, Northern Territory, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Radiation Oncology Services - Mater Centre

South Brisbane, Queensland, Australia

Townsville Hospital

Townsville, Queensland, Australia

Key Dates

Start Date

October 1, 2007

Primary Completion Date

September 1, 2017

Completion Date

June 1, 2022

Last Updated

January 7, 2021

Enrollment

220

ESTIMATED participants

Conditions

Metastatic Melanoma

Interventions

WBRT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma

Inclusion Criteria

Exclusion Criteria

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