Background: Primary surgery is usually the mainstay treatment in early-stage oropharyngeal and oral cavity cancer. Typically, neck surgery is performed. Negative tumor margins are recommended (> 5 mm). If feasible, re-resection of any positive margin is preferred. Otherwise, postoperative radiotherapy is required. Adjuvant postoperative radiotherapy can be limited to the primary site for patients with pT1-T2 tumors and negative neck exploration. Currently, both fractionated external beam radiotherapy and brachytherapy can have a role in the postoperative management of early-stage oropharyngeal and oral cavity cancer with high risk margins. Another possible alternative could be postoperative stereotactic body radiotherapy (SBRT). The aim of this study is to evaluate postoperative SBRT in the treatment of early-stage oropharyngeal and oral cavity cancer with high risk margins.
Methods: The STEREO POSTOP study is a national, open-label, non-randomized phase II trial within the GORTEC network. Patients with early-stage oropharyngeal and oral cavity cancers with high risk margins indicating the need for postoperative radiation are eligible for enrollment. SBRT consists of a total dose of 36 Gy in 6 fractions over 2 weeks. The primary endpoint is severe late toxicity defined as 2-year toxicity of grade ≥ 3 according to CTCAE V4.03 classification. The secondary endpoints include acute toxicity (≤ 3 months), local and locoregional control, disease-free and overall survival, quality of life of patients, nutritional impact and predictive factors of toxicity. The experimental design chosen is a one-step Fleming plan design without interim analysis as the primary endpoint will be evaluated at a 2-year follow-up. Ninety patients will be recruited. The study was started in January 2018 with a 4-year enrollment period and an estimated completion in January 2024.
Discussion: This study is the first prospective trial to evaluate head and neck cancer postoperative SBRT in the setting of early-stage oropharyngeal and oral cavity cancers with high risk margins. SBRT is an attractive option because it delivers a highly conformal dose of radiation in a limited number of fractions (like brachytherapy but with less contraindication), with steep dose gradients resulting in reduced normal tissue irradiation and with a short overall treatment time.
Trial Registration: Clinicaltrials.gov : NCT03401840 , registered on 17-1-2018. Identifier in French National Agency for the Safety of Medicines and Health Products (ANSM): N°ID - RCB 2017-A02058-45, registered on July 2017. Protocol version: Version 3 dated from 25th November 2019.
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http://dx.doi.org/10.1186/s12885-020-07231-3 | DOI Listing |
Head Neck
November 2024
Department of Otolaryngology - Head and Neck Surgery, Western University, London, Ontario, Canada.
Background: This ORATOR sub-study evaluated swallowing physiology in patients treated with transoral robotic surgery (TORS) versus radiotherapy (RT) for early-stage oropharynx cancer.
Methods: Swallowing physiology was evaluated using videofluoroscopy and outcomes were compared across treatment arms and correlated with MDADI scores.
Results: Of the 68 patients in the ORATOR trial, 21 participated in this sub-study (30.
Dysphagia
October 2024
Faculty of Medicine, Department of Geriatric Medicine, Bezmialem Vakıf University, İstanbul, Türkiye.
Dysphagia is defined as difficulty in swallowing, while presbyphagia is described as a change in swallowing process in healthy older adults, which is a compensable physiological impairment and synonymous with dysphagia. Aging is a well-known risk factor for Alzheimer's disease (AD), and oropharyngeal dysphagia (OD) is a common condition in AD. Our study aims to compare OD in AD patients and older adults with presbyphagia (OAwP).
View Article and Find Full Text PDFAuris Nasus Larynx
December 2024
Department of Otolaryngology-Head and Neck Surgery, Gifu University Graduate School of Medicine, Japan.
J Pharm Bioallied Sci
July 2024
Department of Oncopathology, State Cancer Institute, Guwahati Medical College, Assam, India.
Unlabelled: As per Globocan 2012, every year the incidence of head and neck cancer is 683235/1000000 with a mortality of around 375665/1000000 thus being the sixth cause of cancer death throughout the world. Head and neck cancer includes cancer of the nasopharynx, oropharynx, hypopharynx, larynx, and oral cavity. Early diagnosis of head and neck cancer is very challenging, hence detecting mucosal lesions at an early stage decreases mortality thereby improving overall survival, disease-free survival, and quality of life.
View Article and Find Full Text PDFEar Nose Throat J
September 2024
Department of Otorhinolaryngology, Head & Neck Surgery, Merciful Brothers Hospital St. Elisabeth, Straubing, Germany.
Head and neck cancer (HNC) is a critical concern in oncology, with notable disparities in survival rates. While the long-term symptom burden in HNC survivors and its impact on quality of life (QoL) has been explored, there is limited understanding of the influence of cancer localizations on these aspects. This study aims to elucidate the role of cancer localizations in shaping long-term outcomes in HNC patients.
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