Abstract
BackgroundLaryngocarcinoma (LC), in most cases a squamous cell carcinoma, accounts for 1 ~ 5% of the incidence of all tumors. At present, laryngocarcinoma is mainly managed with the integration of surgery and radio- and chemo-therapies. The current development trend of treatment is to improve the local control rate of tumor and the quality of life of patients. Intraoperative radiation therapy (IORT) is a radiotherapy that delivers single high dose irradiation at a close range to the tumor bed during the surgical operation process. It has particular radiobiological advantages in protecting normal surrounding tissues by directly applying the irradiation dose to the high-risk tumor bed area.Two forms of IORT, i.e., high dose rate (HDR) brachytherapy and external beam radiotherapy (EBRT, including electron and photono IORT), had been studied before the treatment of head and neck tumors (including laryngocarcinoma). However, no relevant assessment had been carried out on 50KV low-energy X-ray. We are convinced by certain arguments that the application of low-energy X-ray for intraoperative local radiotherapy of laryngocarcinoma can not only achieve the therapeutic effect of IORT but also reduce the incidence of high-energy irradiation related toxic and side effects. The purpose of this study is to observe the safety and short-term efficacy of IORT when used in conjunction with standard of care for the treatment of local advanced laryngocarcinoma (LAL).Methods/designIn consideration of the applications of precise targeted IORT in oncosurgery and in line with the application range and reference clinical medical guidances approved by SFDA (ZEISS radiosurgical operation system has been used for the treatment of solid tumors since 31 December, 2013 with an approval from SFDA), we have preliminarily planned the tumors suitable for IORT, determined the members of MDT in our hospital, improved the MDT diagnosis and treatment processes for the tumors, established the standards, indications and contraindications for the application of IORT, determined the indicators to be observed after the treatment of tumors with surgical operations plus IORT, and carried out follow-up visits and statistical analysis.This is a single-arm, prospective Phase II clinical trial of the treatment of LAL patients with IORT + EBRT. The study subjects are followed up for statistics and information of their acute/chronic toxic reactions and local control rate, DFS, and OS etc. The safety and short-term efficacy of the application of IORT as SIB for the treatment of LAL. The sample size of the study is 125 subjects.DiscussionThe safety and efficacy of IORT for the treatment of head and neck cancers have been proven in studies by multiple institutions (1–3). The purpose of this study is to investigate the maximum safe dose and short-term efficacy of IORT for providing a theoretical basis for clinical trials.Trial registrationTrial registration: Clinicaltrials.gov, NCT04278638. Registered 18 February 2020 - prospectively registered, https://clinicaltrials.gov/ct2/show/NCT04278638
Highlights
Laryngocarcinoma (LC), in most cases a squamous cell carcinoma, accounts for 1 ~ 5% of the incidence of all tumors
The safety and efficacy of Intraoperative radiation therapy (IORT) for the treatment of head and neck cancers have been proven in studies by multiple institutions (1–3)
The purpose of this study is to investigate the maximum safe dose and shortterm efficacy of IORT for providing a theoretical basis for clinical trials
Summary
Head and neck tumors are generally treated with an integrated treatment modality by a multi-disciplinary team (MDT). This study aims to investigate whether the addition of low-energy X-ray source IORT to the standard of care of LAL for instantaneous SIB featuring high precision, high dose, and high biological effect can be effectively used in place of EBRT in order to reduce the local recurrence rate of LAL. IORT and conventional EBRT can mutually make up for each other’s shortcomings: the shortcoming of conventional radiotherapy, i.e., its inability to deliver high irradiation dose to target area due to the restriction of sensitive surrounding tissues/organs, can be addressed by IORT; the shortcomings of IORT, i.e., the nonuniform irradiation and limited irradiation unit dose during its application in target areas of irregular shapes, can be remedied by EBRT. The combination of IORT and postoperative conventional irradiation can achieve ideal results featuring high irradiation dose in tumor target areas and complete irradiation dose coverage in areas at risk. Considering the huge potential of IORT for improving local control, we are looking forward to use this study to evaluate the effect of IORT in the treatment of LAL
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