Accrual to a Randomised Trial of Whole Brain Radiotherapy in Melanoma Brain Metastases is Feasible. (#334)
Brain metastases are a common cause of death in melanoma. Immediate whole brain radiotherapy (WBRT) following local treatment of intracranial melanoma metastases with neurosurgery and/or stereotactic radiosurgery is controversial. A randomised trial is needed. However, accrual in WBRT trials has been problematic. A feasibility study under the auspices of the Australia and New Zealand Melanoma Trials Group (ANZMTG) was conducted to see if accrual was possible.
A feasibility study that randomised patients to the same protocol that would be used in a full study was planned. Other relevant trials groups were enlisted. Institutions were asked for feasibility forecasts. International collaboration was sought. The goal was to accrue 60 patients in 2 years. Funding application from government sources was successful.
54 eligible patients were accrued in 26 months (May 2009 to June 2011). 15 were from Norway. There were 220 screen failures. Baseline analysis of this population demographic showed even distribution between the arms and will be presented. There were no trial related significant adverse events. Data quality was high especially with completion of neurocognitive and Quality of life assessments.
The feasibility study was deemed successful. International collaborations have been crucial. Actual accrual from sites is very different from their own estimated feasibility.
Government funding was achieved for the full study. Accrual to the full study is now underway. 111 patients of a needed 200 have been accrued. A planned interim analysis 12 months after the randomisation of the 100th patient is due in December 2013.