🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Germany / NCT02984410
Active, not recruiting Not applicable

Study Assessing The "Best of" Radiotherapy vs the "Best of" Surgery in Patients With Oropharyngeal Carcinoma

NCT02984410 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2017-11-27
Last updated
2025-08-14

Condition(s) studied

Oropharyngeal CancerSupraglottic Squamous Cell CarcinomaHypopharyngeal Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

Intensity-Modulated Radiation Therapy (IMRT)Trans Oral Surgery (TOS)

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Main Inclusion Criteria: * OPSCC in one of the following sub-sites: base of tongue, lateral pharyngeal wall, tonsil, glosso-tonsillar sulcus, vallecula or SGSCC in one or more of the following sub-sites: epiglottis, aryepiglottic fold, false cord or HPSCC in one or more of the following subsites: Lateral and medial wall of piriform sinus (sub-sites are defined as lateral (lateral pharyngeal wall, tonsil, glosso-tonsillar sulcus, lateral piriform sinus) vs. central lesions (base of tongue, vallecula, all supraglottic sites, medial wall of piriform sinus)) * TNM stage I-III (7th AJCC classification): T1 or T2, N0 or T1 or T2, N1 with one single neck node ≤ 3cm without radiographic signs of extracapsular extension (ECE), M0; * TNM stage I for HPSCC: T1, N0, M0. ; * Within 2 weeks before randomization, assessment by a Multi-Disciplinary Team (MDT) composed of at least a head and neck/ENT surgeon, oncologist, radiologist, radiotherapist, and pathologist of the treatment naïve patient and suitable for either TOS or IMRT based on: * CT with contrast and/or MRI done within 4 weeks prior to randomization Note: Repeat contrast enhanced CT and/or MRI or US 1 week or less prior to randomization in case of suspicious nodes \<1cm on initial scan if per local practice * Pan-endoscopy with assessment of trans-oral exposure for resection. * peri-nodal infiltration either via CT-scan or MRI. * Age 18 and older; Age 18 to 70 for SGSCC * ECOG Performance status ≤ 2; * Availability of biological material for HPV/p16 testing for OPSCCs * Study information and Informed consent discussed by the surgeon and radio-oncologist and signed by the patient. * Within 2 weeks prior randomization: * Baseline MDADI score available; * Adequate bone marrow function as demonstrated by neutrophils count \> 1,5 109 /L , platelets count \> 75 109 /L, WBC≥ 3.0 109 /L; * Prothrombin time (PT) with an international normalized ratio (INR) ≤ 1.2 * Partial thromboplastin time (PTT) ≤ 1.2 times ULN * Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test no more than 72 hours prior to randomization. * Patients of childbearing / reproductive potential should agree to use adequate birth control measures for 3 months, especially if they will undergo any radiotherapy treatment at any time during the study. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Main Exclusion Criteria: * Any previous anti-cancer therapy for HNSCC (surgery, chemo-, or radiotherapy or molecular targeted therapy); * Any active malignancy (other than non-melanoma skin cancer or localized cervical cancer or localized and presumed cured prostatic cancer) within the last 5 years with ongoing systemic treatment * Cancer in contact with the internal and/or common carotid artery * Extension of OPSCC across the midline of the base-of-tongue * Arytenoid involvement in case of SGSCC * Infiltration of apex for piriform sinus in case of HPSCC * Cancer originating from the soft palate or posterior pharyngeal wall * Requirement of a reconstruction with a free or regional flap (i.e. involvement of \>50% of the soft palate) * Pre-existing dysphagia not related to the oropharyngeal cancer or diagnostic biopsies * Any psychological, cognitive, familial, sociological or geographical condition potentially hampering compliance with the study protocol, completion of patient reported measures and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Primary outcome measure(s)

Trial sites (32)

FacilityCityRegionStatus
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

More European Organisation for Research and Treatment of Cancer - EORTC trials in Germany

Other trials for the same condition

Official registry record

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