Best-Of is a phase III study assessing the "Best-Of" radiotherapy compared to the "Best-Of" surgery (trans-oral surgery (TOS) in patients with T1-T2, N0 oropharyngeal carcinoma.
The incidence of Oropharyngeal Squamous Cell Carcinoma (OPSCC) has increased significantly over the last 10-20 years in developed countries, including the UK. Early stage OPSCC can be effectively managed by either surgery or radiotherapy, with an average 5-year survival rate of over 80%. Reducing long-term toxicities of treatment, particularly swallowing dysfunction, is an important goal in patients who are likely to be cured of their disease.
Transoral surgery, a minimally invasive form of surgery and Intensity Modulated Radiotherapy (IMRT), a highly targeted form of radiotherapy, are both regarded as standards of care for the management of early stage OPSCC. Both treatments are associated with high tumour control rates, but with different side-effect profiles, such that there are advantages and disadvantages to both treatments. The ‘Best-Of’ study will compare the ‘best-of’ transoral surgery and the ‘best-of’ IMRT, for the treatment of patients with early stage OPSCC. The study aims to establish whether both of these treatments are really as effective as each other and which treatment results in the least side-effects and the best quality of life for patients, especially with regards to swallowing function.
The study is a randomised phase III, multi-centre trial, recruiting a total of 170 patients across Europe, with 40 patients from the UK, over a 2-year period. Patients will be randomised to receive either transoral surgery or IMRT. The primary endpoint is swallowing function using the M.D. Anderson Dysphagia Inventory (MDADI) within 12 months following treatment.
Secondary objectives include the patients’ disease and survival status and functional outcome in terms of swallowing and quality of life. Patients will be followed-up for a period of up to 5 years. The ‘Best-Of’ study has the potential to change clinical practice internationally by providing an evidence-base on which to recommend a future standard of care for early stage OPSCC.
|Start date||1 Jun 2018|
|End date||31 Jan 2025|