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Study Assessing The "Best of" Radiotherapy vs the "Best of" Surgery in Patients With Oropharyngeal Carcinoma
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Summary
Oropharyngeal Squamous Cell Carcinoma (OPSCC) arises in the soft palate, tonsils, base of tongue, pharyngeal wall, and the vallecula. Most of the patients with early stage OPSCC are usually cured. Treatment of early stage OPSCC can be successfully achieved with primary surgery including neck dissection, as indicated, or with definitive radiotherapy. The current standard treatment for OPSCC is therefore based on either surgery and/or radiotherapy, both associated with comparable, high tumor control rates but with different side effects profiles and technical constraints. In order to decrease the potential morbidity of surgery, transoral approaches have been developed within the last decades, including transoral robotic surgery (TORS), transoral laser microsurgery (TLM) or conventional transoral techniques. On the other hand, patients with head and neck cancer treated with IMRT experienced significant improvements in cause specific survival (CSS) compared with patients treated with non-IMRT techniques thus suggesting that IMRT may be beneficial in terms of patient's outcomes and toxicity profile. It is as yet unclear however, which one of the new techniques is superior to the other in terms of function preservation. Given that the functional outcome of most importance is swallowing function, the preservation of swallowing is thus of major importance. The main objective of the study is to assess and compare the patient-reported swallowing function over the first year after randomization to either IMRT or TOS among patients with early stage OPSCC, SGSCC, and HPSCC.
Official title: Phase III Study Assessing the "Best of" Radiotherapy Compared to the "Best of" Surgery (Trans-oral Surgery (TOS)) in Patients With T1-T2, N0-N1 Oropharyngeal, Supraglottic Carcinoma and With T1, N0 Hypopharyngeal Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
112
Start Date
2017-11-27
Completion Date
2029-06-30
Last Updated
2025-08-14
Healthy Volunteers
No
Conditions
Interventions
Intensity-Modulated Radiation Therapy (IMRT)
IMRT (Simultaneous Integrated Boost (SIB) and accelerated regimen) with selective neck node dissection
Trans Oral Surgery (TOS)
TOS (Trans Oral Laser Microsurgery (TLM), Trans Oral Robotic Surgery (TORS), conventional) with selective neck node dissection
Locations (32)
CHU-UCL Namur - CHU Mont Godinne
Namur, Yvoir, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Institut Jules Bordet-Hopital Universitaire ULB
Brussels, Belgium
U.Z. Leuven - Campus Gasthuisberg
Leuven, Belgium
Hopitaux Universitaires de Strasbourg - Hautepierre
Strasbourg, France
Universitaetsklinikum Koeln
Cologne, Germany
Universitaetklinikum Halle - Martin Luther Universitaet
Halle, Germany
Universitaets Krankenhaus Eppendorf - UKE - University Cancer Center
Hamburg, Germany
Universitaetsklinikum Jena
Jena, Germany
Staedtisches Klinikum Leipzig - Klinikum St Georg
Leipzig, Germany
Universitaetsklinikum Leipzig
Leipzig, Germany
Klinikum Rechts der isar Der Technische Universitaet Muenchen
München, Germany
Universitaetsklinikum Tuebingen- Crona Kliniken
Tübingen, Germany
Universitaetsklinikum Ulm-Michelsberg-HNO
Ulm, Germany
Istituto Clinico Humanitas
Milan, Italy
Istituto Europeo di Oncologia
Milan, Italy
The Great Poland Cancer Centre
Poznan, Poland
Hospital Universitario Donostia
Barcelona, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hospital Universitario Central De Asturias
Oviedo, Spain
Universitaetsspital Basel
Basel, Switzerland
Inselspital
Bern, Switzerland
Centre Hospitalier Universitaire Vaudois - Lausanne
Lausanne, Switzerland
UniversitaetsSpital Zurich - Klinik fur Ohren, Hals und Gesichtschirurgie
Zurich, Switzerland
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
Bristol, United Kingdom
Cambridge University Hospital NHS - Addenbrookes Hospital
Cambridge, United Kingdom
Cardiff and Vale University Health Board - University Hospital of Wales
Cardiff, United Kingdom
Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital
Cottingham, United Kingdom
Aintree University Hospital NHS Trust
Liverpool, United Kingdom
Guy's and St Thomas' NHS Foundation trust - Guy s and St Thomas' NHS - Guy's Hospital
London, United Kingdom
Imperial College Healthcare NHS Trust - Charing Cross Hospital
London, United Kingdom
South Tees Hospitals NHS Foundation Trust - The James Cook University Hospital
Middlesbrough, United Kingdom