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
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.
| Facility | City | Region | Status |
|---|---|---|---|
| CHU-UCL Namur - CHU Mont Godinne | Namur | Yvoir | |
| 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 |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02984410 on ClinicalTrials.gov ↗ ← All trials in Germany