Status:
UNKNOWN
Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma
Lead Sponsor:
Melanoma and Skin Cancer Trials Limited
Collaborating Sponsors:
Trans Tasman Radiation Oncology Group
University of Oxford
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT01503827
Start Date
October 1 2007
End Date
June 1 2022
Last Update
January 7 2021
Active Locations (23)
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1
St Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
2
Calvary Mater Hospital
Newcastle, New South Wales, Australia, 2310
3
Genesis Cancer Care - Gateshead
Newcastle, New South Wales, Australia
4
Melanoma Institute Australia / Royal Prince Alfred Hospital
North Sydney, New South Wales, Australia, 2060