Whole brain radiotherapy (WBRT) after local treatment of brain metastases in melanoma patients: Statistical Analysis Plan

Lo, SN; Hong, AM; Haydu, LE; Ahmed, T; Paton, EJ; Steel, V; Hruby, G; Tran, A; Morton, RL; Nowak, AK; Vardy, JL; Drummond, KJ; Dhillon, HM; Mandel, C; Scolyer, RA; Middleton, MR; Burmeister, BH; Thompson, JF; Fogarty, GB

Whole brain radiotherapy (WBRT) after local treatment of brain metastases in melanoma patients: Statistical Analysis Plan

Lo, SN Hong, AM Haydu, LE Ahmed, T Paton, EJ Steel, V Hruby, G Tran, A Morton, RL Nowak, AK Vardy, JL Drummond, KJ Dhillon, HM Mandel, C Scolyer, RA Middleton, MR Burmeister, BH Thompson, JF Fogarty, GB

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Publisher:: Springer Science and Business Media LLC
Publication Type:: Journal Article
Citation:: Trials, 2019, 20 (1), pp. ? - ? (13)
Issue Date:: 2019-12

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Field	Value	Language
dc.contributor.author	Lo, SN	en_US
dc.contributor.author	Hong, AM	en_US
dc.contributor.author	Haydu, LE	en_US
dc.contributor.author	Ahmed, T	en_US
dc.contributor.author	Paton, EJ	en_US
dc.contributor.author	Steel, V	en_US
dc.contributor.author	Hruby, G	en_US
dc.contributor.author	Tran, A	en_US
dc.contributor.author	Morton, RL	en_US
dc.contributor.author	Nowak, AK	en_US
dc.contributor.author	Vardy, JL	en_US
dc.contributor.author	Drummond, KJ	en_US
dc.contributor.author	Dhillon, HM	en_US
dc.contributor.author	Mandel, C	en_US
dc.contributor.author	Scolyer, RA	en_US
dc.contributor.author	Middleton, MR	en_US
dc.contributor.author	Burmeister, BH	en_US
dc.contributor.author	Thompson, JF	en_US
dc.contributor.author	Fogarty, GB https://orcid.org/0000-0002-0764-578X	en_US
dc.date.issued	2019-12	en_US
dc.identifier.citation	Trials, 2019, 20 (1), pp. ? - ? (13)	en_US
dc.identifier.uri	http://hdl.handle.net/10453/139592
dc.description.abstract	Background The WBRTMel trial is a multinational, open-label, phase III randomised controlled trial comparing whole brain radiotherapy (WBRT) to observation following local treatment of one to three melanoma brain metastases with surgery and/or stereotactic irradiation. The primary trial endpoint was to determine the effect of adding WBRT to local treatment on distant intracranial control, and the secondary endpoints were neurocognitive function, quality of life (QoL), performance status, overall survival, death from intracranial causes, death from melanoma and cost-effectiveness. Objective The objective of this update is to outline and publish the pre-determined statistical analysis plan (SAP) before the database lock and the start of analysis. Methods The SAP describes basic analysis principles, methods for dealing with a range of commonly encountered data analysis issues and the specific statistical procedures for analysing efficacy and safety outcomes. The SAP was approved after closure of recruitment and before completion of patient follow-up. It outlines the planned primary analyses and a range of subgroup and sensitivity analyses regarding the clinical and QoL outcomes. Health economic outcomes are not included in this plan but will be analysed separately. The SAP will be adhered to for the final data analysis of this trial to avoid analysis bias arising from knowledge of the data. Results The resulting SAP is consistent with best practice and will allow open and transparent reporting. Conclusion We have developed a SAP for the WBRTMel trial which will be followed to ensure high-quality standards of internal validity to minimise analysis bias.	en_US
dc.language	en	en_US
dc.publisher	Springer Science and Business Media LLC	en_US
dc.relation.ispartof	Trials	en_US
dc.relation.isbasedon	10.1186/s13063-019-3555-5	en_US
dc.rights	This is a post-peer-review, pre-copyedit version of an article published in Trials. The final authenticated version is available online at: https://dx.doi.org/10.1186/s13063-019-3555-5.	en_US
dc.subject.classification	Cardiovascular System & Hematology	en_US
dc.subject.classification	General & Internal Medicine	en_US
dc.title	Whole brain radiotherapy (WBRT) after local treatment of brain metastases in melanoma patients: Statistical Analysis Plan	en_US
dc.type	Journal Article
utslib.citation.volume	1	en_US
utslib.citation.volume	20	en_US
utslib.for	1102 Cardiorespiratory Medicine and Haematology	en_US
utslib.for	1103 Clinical Sciences	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Engineering and Information Technology
utslib.copyright.status	open_access
pubs.consider-herdc	true	en_US
pubs.issue	1	en_US
pubs.publication-status	Published	en_US
pubs.volume	20	en_US

Abstract:

Background The WBRTMel trial is a multinational, open-label, phase III randomised controlled trial comparing whole brain radiotherapy (WBRT) to observation following local treatment of one to three melanoma brain metastases with surgery and/or stereotactic irradiation. The primary trial endpoint was to determine the effect of adding WBRT to local treatment on distant intracranial control, and the secondary endpoints were neurocognitive function, quality of life (QoL), performance status, overall survival, death from intracranial causes, death from melanoma and cost-effectiveness. Objective The objective of this update is to outline and publish the pre-determined statistical analysis plan (SAP) before the database lock and the start of analysis. Methods The SAP describes basic analysis principles, methods for dealing with a range of commonly encountered data analysis issues and the specific statistical procedures for analysing efficacy and safety outcomes. The SAP was approved after closure of recruitment and before completion of patient follow-up. It outlines the planned primary analyses and a range of subgroup and sensitivity analyses regarding the clinical and QoL outcomes. Health economic outcomes are not included in this plan but will be analysed separately. The SAP will be adhered to for the final data analysis of this trial to avoid analysis bias arising from knowledge of the data. Results The resulting SAP is consistent with best practice and will allow open and transparent reporting. Conclusion We have developed a SAP for the WBRTMel trial which will be followed to ensure high-quality standards of internal validity to minimise analysis bias.

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http://hdl.handle.net/10453/139592