Abstract 706TiP
Background
The current standard treatment for early stage OPSCC/SGSCC, and HPSCC is either surgery or radiotherapy, both with comparable high tumor control rates but with different side effect profiles and technical constraints. Treatment choice is generally based on institutional and patient preference but not on level 1 evidence with respect to functional recovery. Recently the introduction of techniques such as trans-oral laser and robotic surgery (TOS) and dysphagia optimized IMRT (DO-IMRT) have led to an improvement of treatment related side effects. To compare these novel techniques with respect to functional swallowing recovery, we proposed a randomized trial to evaluate TOS and DO-IMRT in terms of its impact on swallowing function.
Trial design
This is a phase III randomized controlled trial that assesses swallowing function based on the MD Anderson Dysphagia Inventory (MDADI) score reported by the patients at months 4.5 and 12 after randomization. BEST OF is powered to detect a minimally important clinical difference of 10 points at each of these time points, to allow for a comparison of the evolution of swallowing recovery with both techniques. Key secondary endpoints include the MDADI at 6 and 9 months, oncologic outcomes at year 1 and 5, toxicities according to CTCAE v4.03, quality of TOS and radiotherapy, PSS-HN, water swallow test, quality-of-life measured by the EORTC-HN35 and QLQ-C30, financial toxicity per country, and other patient reported outcomes. The main inclusion criteria are trans-orally resectable T1/T2, N0-1, M0 OPSCC/SGSCC, and T1 N0 HPSCC assessed by a multidisciplinary team (TNM version AJCC 7.0). An integrated quality assurance program for surgery, pathology and radiotherapy is implemented in the BEST OF study using the EORTC RTQA and SURCARE platforms. The study is to enroll 112 patients. Enrollment has started on 27/03/2018. Recruitment has reached the 50% mark at 1/2022 and a mid-accrual assessment of the statistical design is currently underway. The study is open for recruitment in 29 European centers. Participating networks include EORTC HNCG, NCRI, GORTEC, and IAG-KHT.
Clinical trial identification
NCT02984410.
Editorial acknowledgement
Legal entity responsible for the study
EORTC.
Funding
FOCA, Belgium; Fondation Georges Dreyfus, Switzerland; SAKK, Switzerland; Gortec, France; Deutsche Krebshilfe, Germany; CRUK, UK.
Disclosure
All authors have declared no conflicts of interest.