Hypofractionated Radiotherapy Based on Tomotherapy Application for Limited-Stage Small Cell Lung Cancer: Study Protocol for a Randomized, Controlled Trial

Abstract

\n BackgroundTomotherapy (TOMO), also known as spiral tomotherapy, offers better dose distribution, mild radiotherapy responses, shorter single-treatment times, and the benefits of timely adjustment of set errors. The overall treatment time of hypofractionated radiotherapy (HFRT) does not increase compared with that of conventional radiotherapy (Con-RT); thus, HFRT is considered the most promising and attractive alternative to standard segmentation. The effect of HFRT based on TOMO technology on limited-stage small cell lung cancer (LS-SCLC) patients requires further investigation.MethodsThe number of samples required was calculated using PASS software, and this randomized, controlled, prospective study will include 120 LS-SCLC patients randomized (1:1) to the experiment group (HFRT with TOMO) or the control group (Con-RT). The primary outcome is progression-free survival time after treatment with HFRT with TOMO. Secondary outcomes include acute and chronic adverse reactions, overall survival, tumor response (stable disease, progressive disease, complete response, and partial response), and quality of life. The follow-up duration will be 2 years. This is version 1.0 of protocol on April 1, 2021. The start of recruitment for this clinical trial is July 1, 2020, and the completion of recruitment is January 1, 2022. DiscussionThis new experimental study aims to explore the selection criteria of instruments during LS-SCLC radiotherapy and provide data theory support for the specified treatment specifications and guidelines. For problems that may arise in the research, we will solve them through statistical methods, such as differential analysis, and project funding support. The study is committed to providing better efficacy for patients with LS-SCLC.Trial registrationThis study is registered in the Chinese Clinical Trial Registry, with trial number ChiCTR1900027539 (date of registration: November 17, 2019). (URL:http://www.chictr.org.cn/edit.aspx?pid=45872&htm=4)