BEST OF: A phase III study assessing the best of radiotherapy (Intensity Modulated RadioTherapy, IMRT) compared to the best of surgery (Trans-Oral Surgery, TOS) in patients with T1-T2, N0 oropharyngeal squamous cell carcinoma (OPSCC).

Authors

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Christian Simon

CHUV - Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

Christian Simon , Carmela Aves Caballero , Catherine Fortpied , Mererid Evans , Petri Koivunen , Jean-Jacques Stelmes , Maria Urbanowicz , Jean Bourhis , Frank Zimmermann , Jens Peter Klussmann , Andreas Dietz , Giuseppe Spriano , C. Rene Leemans , Susanne Singer , Inge Tinhofer , Joanne Patterson , Silvana Quaglini , Keith Hunter , Vincent Gregoire

Organizations

CHUV - Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland, European Society of Medical Oncology, Brussels, Belgium, EORTC Headquarters, Brussels, Belgium, Velindre NHS Trust, Cardiff, United Kingdom, Oulu University Hospital, Oulu, Finland, European Organisation for Research and Treatment of Cancer, Brussels, Belgium, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland, University Hospital Basel, Basel, Switzerland, ENT Department University Gießen, Gießen, Germany, University of Leipzig, Leipzig, Germany, Istituto Nazionale Tumori Regina Elena, Rome, Italy, Department of Otolaryngology/Head and Neck Surgery, VU University Medical Center, Amsterdam, Netherlands, Department of Radiooncology and Radiotherapy, Charité University Hospital and German Cancer Research Center Heidelberg (DKFZ)/German Cancer Consortium (DKTK), Berlin, Germany, Newcastle University, Newcastle upon Tyne, United Kingdom, Dept. of Electrical, Computer and Biomedical Engineering, University of Pavia, Pavia, Italy, The University of Sheffield, Sheffield, United Kingdom, Cliniques Universitaires Saint-Luc, Brussels, Belgium

Research Funding

Other

Background: The incidence of OPSCC has increased dramatically in the last 15 years. The standard treatment for early stage disease 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 expert or center experience. It is still unclear whether they differ in terms of functional outcome. To clarify this, we proposed a randomised trial with the primary objective to assess and compare the patient-reported swallowing function over the first year after randomisation to either IMRT or TOS among patients with early stage OPSCC. Clinician and patient-reported outcomes will be used to assess treatment. Methods: This is a phase III randomised trial (NCT02984410) that will primarily assess the MD Anderson Dysphagia Inventory (MDADI) score reported by the patients at months 4.5, 6, 9, and 12 after randomisation. MDADI is composed of 19 questions on emotional, functional, and physical aspects, all related to swallowing, wherein scores range between 20 (poorest function) and 100 (best function). BEST OF is powered to detect a clinically significant difference in MDADI score at each of these time points: 4.5, 6, 9, and 12 months with a planned sample size of 170 patients. Key secondary endpoints include treatment response at 6 months after randomization, oncologic outcomes at year 1 and 5, toxicities based on CTCAE, quality of life (QOL) based on QLQ-C30 and HN43 and out-of-pocket costs. QOL domains will be ranked based on patient's priorities. Eligible cases are resectable T1 or T2, N0, M0 OPSCC assessed by a multidisciplinary team. The EORTC quality assurance program (QA) for surgery and pathology (SURCARE) and radiotherapy (RTQA) was implemented in the study. This integrated QA will be the model for future EORTC Head and Neck Cancer trials. BEST OF was opened for recruitment since December 2017 in Belgium and Switzerland and will soon open in France, UK, Germany, Poland, Italy and Portugal through a collaboration with EORTC HNCG and ROG, SAKK, NCRI, GORTEC, and IAG-KHT. Clinical trial information: NCT02984410

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Abstract Details

Meeting

2018 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Head and Neck Cancer

Track

Head and Neck Cancer

Sub Track

Local-Regional Disease

Clinical Trial Registration Number

NCT02984410

Citation

J Clin Oncol 36, 2018 (suppl; abstr TPS6098)

DOI

10.1200/JCO.2018.36.15_suppl.TPS6098

Abstract #

TPS6098

Poster Bd #

82a

Abstract Disclosures