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NCT02984410
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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

View on ClinicalTrials.gov

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

Interventions

RADIATION

Intensity-Modulated Radiation Therapy (IMRT)

IMRT (Simultaneous Integrated Boost (SIB) and accelerated regimen) with selective neck node dissection

PROCEDURE

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