PMID- 25952979 OWN - NLM STAT- MEDLINE DCOM- 20160120 LR - 20181113 IS - 1756-0500 (Electronic) IS - 1756-0500 (Linking) VI - 8 DP - 2015 May 8 TI - First interim analysis of a randomised trial of whole brain radiotherapy in melanoma brain metastases confirms high data quality. PG - 192 LID - 10.1186/s13104-015-1153-5 [doi] LID - 192 AB - BACKGROUND: Brain metastases are a common cause of death in patients with melanoma. The role of adjuvant whole brain radiotherapy (WBRT) following local treatment of intracranial melanoma metastases is controversial. The Australian and New Zealand Melanoma Trials Group (ANZMTG) and the Trans-Tasman Radiation Oncology Group (TROG) are leading the first ever single histology randomised trial investigating this question. The primary endpoint is distant intracranial failure on magnetic resonance imaging (MRI) within twelve months of randomisation. The first planned interim analysis was performed twelve months after randomisation of the 100(th) patient. The analysis was an opportunity to review completeness of the trial data to date. METHODS: All data received up to the end of twelve months after randomisation of the 100th patient was reviewed. RESULTS: Review of pathology reports confirmed that all 100 patients had stage IV melanoma and were appropriately entered into the study. Of the 47 distant intracranial events, 34 occurred in isolation (i.e. only distant failure was identified), whilst 13 were accompanied by local failure. Data review showed compliance with the protocol mandated MRI schedule and accuracy of intracranial failure reporting was very high. The Quality of Life (QoL) component of the study achieved a 91% completion rate. For the neurocognitive function (NCF) assessments, a high completion rate was maintained throughout the 12 month period. Where assessments were not performed at expected time points, valid reasons were noted. Radiotherapy quality was high. Of 50 patients who received WBRT, 32 were reviewed as per protocol design and there was only one major variation out of 308 data points reviewed (0.3%). There were minimal trial related adverse events (AEs) and no serious adverse events (SAEs). Pre-specified protocol stopping rules were not met. CONCLUSIONS: The Data Safety Monitoring Committee (DSMC) recommended the trial continue recruitment after reviewing the unblinded data. The data provision and quality to date indicates that a reliable outcome will be obtained when the final analysis is performed. Accrual is ongoing with 156 out of 200 patients randomised to date (26(th) November 2014). FAU - Fogarty, Gerald B AU - Fogarty GB AD - Melanoma Institute Australia, Sydney, Australia. gerald.fogarty@cancer.com.au. AD - Department of Radiation Oncology, St Vincent's General Hospital, Sydney, Australia. gerald.fogarty@cancer.com.au. AD - Genesis Cancer Care, Department of Radiation Oncology, Mater Hospital, Sydney, Australia. gerald.fogarty@cancer.com.au. AD - Trans-Tasman Radiation Oncology Group (TROG), Newcastle, Australia. gerald.fogarty@cancer.com.au. AD - Australia and New Zealand Melanoma Trials Group (ANZMTG), North Sydney, Australia. gerald.fogarty@cancer.com.au. FAU - Hong, Angela AU - Hong A AD - Melanoma Institute Australia, Sydney, Australia. Angela.Hong@melanoma.org.au. AD - Trans-Tasman Radiation Oncology Group (TROG), Newcastle, Australia. Angela.Hong@melanoma.org.au. AD - Sydney Medical School, |The University of Sydney, Sydney, Australia. Angela.Hong@melanoma.org.au. FAU - Dolven-Jacobsen, Kari AU - Dolven-Jacobsen K AD - Oslo University Hospital HF, The Norwegian Radium Hospital, Oslo, Norway. KDJ@ous-hf.no. FAU - Reisse, Claudius H AU - Reisse CH AD - Oslo University Hospital HF, The Norwegian Radium Hospital, Oslo, Norway. clarei@ous-hf.no. FAU - Burmeister, Bryan AU - Burmeister B AD - Trans-Tasman Radiation Oncology Group (TROG), Newcastle, Australia. Bryan.Burmeister@health.qld.gov.au. AD - Princess Alexandra Hospital, Brisbane, Australia. Bryan.Burmeister@health.qld.gov.au. AD - Australia and New Zealand Melanoma Trials Group (ANZMTG), North Sydney, Australia. Bryan.Burmeister@health.qld.gov.au. FAU - Haydu, Lauren H AU - Haydu LH AD - Melanoma Institute Australia, Sydney, Australia. LEHaydu@mdanderson.org. FAU - Dhillon, Haryana AU - Dhillon H AD - Centre for Medical Psychology & Evidence-based Decision-making, Sydney Medical School, The University of Sydney, Camperdown, NSW, Australia. haryana.dhillon@sydney.edu.au. AD - Psycho-Oncology Co-Operative Research Group (PoCoG), School of Psychology, Faculty of Science, University of Sydney, Sydney, Australia. haryana.dhillon@sydney.edu.au. FAU - Steel, Victoria AU - Steel V AD - Australia and New Zealand Melanoma Trials Group (ANZMTG), North Sydney, Australia. Victoria.Steel@melanoma.org.au. FAU - Shivalingam, Brindha AU - Shivalingam B AD - Royal Prince Alfred Hospital, Sydney, Australia. brindha@brain-surgeon.com.au. FAU - Drummond, Kate AU - Drummond K AD - The Royal Melbourne Hospital & University of Melbourne, Parkville, Australia. Kate.Drummond@mh.org.au. FAU - Vardy, Janette AU - Vardy J AD - Sydney Medical School, |The University of Sydney, Sydney, Australia. janette.vardy@sydney.edu.au. AD - Centre for Medical Psychology & Evidence-based Decision-making, Sydney Medical School, The University of Sydney, Camperdown, NSW, Australia. janette.vardy@sydney.edu.au. AD - Psycho-Oncology Co-Operative Research Group (PoCoG), School of Psychology, Faculty of Science, University of Sydney, Sydney, Australia. janette.vardy@sydney.edu.au. AD - Concord Repatriation and General Hospital, Concord, Australia. janette.vardy@sydney.edu.au. FAU - Nowak, Anna AU - Nowak A AD - School of Medicine and Pharmacology, University of Western Australia, Crawley, Australia. anna.nowak@uwa.edu.au. AD - Department of Medical Oncology, Sir Charles Gairdner Hospital, Nedlands, Australia. anna.nowak@uwa.edu.au. FAU - Hruby, George AU - Hruby G AD - Sydney Medical School, |The University of Sydney, Sydney, Australia. ghruby@email.cs.nsw.gov.au. AD - Royal Prince Alfred Hospital, Sydney, Australia. ghruby@email.cs.nsw.gov.au. AD - Australia and New Zealand Melanoma Trials Group (ANZMTG), North Sydney, Australia. ghruby@email.cs.nsw.gov.au. FAU - Scolyer, Richard A AU - Scolyer RA AD - Melanoma Institute Australia, Sydney, Australia. richard.scolyer@sswahs.nsw.gov.au. AD - Sydney Medical School, |The University of Sydney, Sydney, Australia. richard.scolyer@sswahs.nsw.gov.au. AD - Royal Prince Alfred Hospital, Sydney, Australia. richard.scolyer@sswahs.nsw.gov.au. FAU - Mandel, Catherine AU - Mandel C AD - Peter MacCallum Cancer Centre East Melbourne & University of Melbourne, Parkville, Australia. mandel@ausdoctors.net. FAU - Thompson, John F AU - Thompson JF AD - Melanoma Institute Australia, Sydney, Australia. John.Thompson@melanoma.org.au. AD - Sydney Medical School, |The University of Sydney, Sydney, Australia. John.Thompson@melanoma.org.au. AD - Royal Prince Alfred Hospital, Sydney, Australia. John.Thompson@melanoma.org.au. AD - Australia and New Zealand Melanoma Trials Group (ANZMTG), North Sydney, Australia. John.Thompson@melanoma.org.au. LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20150508 PL - England TA - BMC Res Notes JT - BMC research notes JID - 101462768 SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Brain Neoplasms/*radiotherapy/*secondary MH - *Data Accuracy MH - Demography MH - Disease Progression MH - Endpoint Determination MH - Female MH - Humans MH - Male MH - Melanoma/*pathology MH - Middle Aged MH - Radiotherapy/adverse effects PMC - PMC4428505 EDAT- 2015/05/09 06:00 MHDA- 2016/01/21 06:00 PMCR- 2015/05/08 CRDT- 2015/05/09 06:00 PHST- 2014/11/27 00:00 [received] PHST- 2015/04/27 00:00 [accepted] PHST- 2015/05/09 06:00 [entrez] PHST- 2015/05/09 06:00 [pubmed] PHST- 2016/01/21 06:00 [medline] PHST- 2015/05/08 00:00 [pmc-release] AID - 10.1186/s13104-015-1153-5 [pii] AID - 1153 [pii] AID - 10.1186/s13104-015-1153-5 [doi] PST - epublish SO - BMC Res Notes. 2015 May 8;8:192. doi: 10.1186/s13104-015-1153-5.