Whole Brain Radiotherapy following local treatment of melanoma brain metastases

Phase 3

Completed

• Conditions: Melanoma brain metastases; Cancer - Malignant melanoma

• Registration Number: ACTRN12607000512426
• Lead Sponsor: Melanoma and Skin Cancer (MASC) Trials

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-09
• Study Completion: 2022-09-23
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

1. 1-3 intracranial metastases on MRI from melanoma, locally treated with either surgical excision and/or stereotactic irradiation. 2. Life expectancy of at least 6 months 3. Aged 18 years or older 4. WBRT must be within 8 weeks of completion of localised treatment and within 4 weeks of randomisation 5. 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 6. Complete localised treatment of all these metastases no more than 6 weeks prior to randomisation 7. An Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less at randomisation 8. CT scan of chest, abdomen and pelvis as a minimum prior to randomisation. Scans must be within 12 weeks of randomisation 9. Serum Lactate Dehydrogenase (LDH) must be = or < 2 x upper limit of normal 10. Able to provide written informed consent

Exclusion Criteria

1.Any untreated intracranial disease
2.Any previous intracranial treatment (surgical excision and/or stereotactic irradiation treatment and/or WBRT) prior to this diagnosis of intracranial melanoma
3.Evidence of leptomeningeal disease on pre-local treatment MRI scan
4.Patients with prior cancers, except:
oThose diagnosed more than five years ago with no evidence of disease recurrence within this time;
oSuccessfully treated basal cell and squamous cell skin carcinoma;
oCarcinoma in-situ of the cervix
5.A medical or psychiatric condition that compromises ability to give informed consent or complete the protocol
6.Positive urine pregnancy test for women of childbearing potential within a week of registration onto the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with distant intracranial failure as determined by magnetic resonance imaging (MRI) assessment[ 12 months post randomisation]