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

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 describ

SUBMITTER: Lo SN 

PROVIDER: S-EPMC6683544 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature