A phase 2 study of stereotactic body radiation therapy for squamous cell carcinoma of the head and neck (SHINE) - a single arm clinical trial protocol

Sep 24, 2026

Uploaded by Liam

Phase 2, single-institution, single-arm study evaluating SBRT for older patients with locally advanced HNSCC when primary surgery is not recommended or performed. Standard head and neck cancer treatments combine surgery, radiation, and chemotherapy, but are linked to high acute toxicity and complications. This trial delivers SBRT 45 Gy in 5 fractions every 3–4 days, with toxicity, quality of life, and patient outcomes tracked regularly for 24 months after treatment completion.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages10

Reading Time25 min

AccessFree to download

Abstract

Background

Methods

Discussion

Trial registration

Keywords

Background

Lee et al. BMC Cancer (2023) 23:379 [https://doi.org/10.1186/s12885-023-10807-4](https://doi.org/10.1186/s12885-023-10807-4) BMC Cancer STUDY PROTOCOL Open Access A phase 2 study of stereotactic body radiation therapy for squamous cell carcinoma of the head and neck (SHINE): a single arm clinical trial protocol Justin Lee 1,2* , Nhu Tram Nguyen1,2, James Wright1,2, Ka‑Kit David Yeung1,2, Stephen Sagar1,2, Do‑Hoon Kim 1,2, Orest Ostapiak1,2, Lilian Doerwald‑Munoz1,2 and Timothy Whelan1,2 Abstract Background Cancers ofthe head and neck region are often characterized by locally advanced, non‑metastatic disease. Standard treatments for advanced cervico‑facial cancers ofthe skin or primary head and neck squamous cell carcinoma (HNSCC) include combinations of surgery, radiation and chemotherapy, which are associated with high rates of acute toxicity and complications. Stereotactic body radiotherapy (SBRT) has been shown to be a promising modality of treatment for this patient population in retrospective studies; to our knowledge, there are no prospective clinical studies evaluating the safety and efficacy of SBRT in these patients. Methods This phase 2, single institution, single arm study aims to evaluate response rates to SBRT in older age patients with locally advanced HNSCC for whom primary surgery is not recommended or performed. The interven‑ tion is SBRT 45 Gy in 5 fractions given every 3–4 days. Toxicity, quality of life and patient outcomes will be recorded regularly up to 24 months after completion of SBRT. Discussion For this patient population, SBRT may offer a shorter and more effective treatment than the current standard of care palliative regimens. If the study demonstrates that SBRT is safe and effective, then this may lead to randomized studies comparing conventional radiotherapy to SBRT for selected head and neck cancer patients. Trial registration [ClinicalTrials.gov](ClinicalTrials.gov) Identifier: NCT04435938. Date registered: June 17, 2020. Keywords Stereotactic radiation therapy, Head and neck cancer, Squamous cell carcinoma, Radiation therapy *Correspondence: Justin Lee [leejus@hhsc.ca](leejus@hhsc.ca) 1 Department of Oncology, Faculty of Health Sciences, McMaster University, Hamilton, Canada 2 Juravinski Cancer Centre, Hamilton Health Sciences, 699 Concession Street, Hamilton, ON, CA L8V 5C2, Canada Background Cancers ofthe head and neck region account for approximately 4% of all new cancer cases. Primary skin cancers are the most common malignancy diagnosed in North America with the majority of tumours arising in the cervico-facial region [1, 2]. Together, these tumours comprise a high burden of illness and are often characterized by locally advanced, non-metastatic disease. Determining the optimal treatment for individual patients with advanced cervico-facial cancers of the skin or primary head and neck squamous cell carcinoma © The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit [http://creativecommons.org/licenses/by/4.0/](http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ()[. The Creative Commons Public Domain Dedication waiver (](http://creativecommons.org/l

FAQs

What treatment does the study evaluate for head and neck cancer?

The study evaluates stereotactic body radiotherapy (SBRT) delivered as 45 Gy in 5 fractions given every 3–4 days.

Who is eligible for this phase 2 single-arm trial?

Older patients with locally advanced HNSCC for whom primary surgery is not recommended or not performed are targeted.

What outcomes are monitored during and after SBRT?

Toxicity, quality of life, and patient outcomes are recorded regularly, with follow-up up to 24 months after completion of SBRT.

Sep 24, 2026

Uploaded by Liam