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Spots Global Cancer Trial Database for Study Assessing The "Best of" Radiotherapy vs the "Best of" Surgery in Patients With Oropharyngeal Carcinoma

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Trial Identification

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

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

Study ID: NCT02984410

Study Description

Brief 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.

Detailed Description: Eligible patients will be randomized 1 to 1 to surgery (Arm 1) or radiotherapy (Arm 2). ARM 1: Surgery Trans-oral surgery (any trans-oral approach such as trans-oral laser microsurgery conventional trans-oral surgery or trans-oral robotic surgery) will be applied to all patients in this arm. A surgical margin is defined to be clear (R0), if found to be \>/=3mm in the final specimen (except deep margin for tonsillar resection, that is either R1 or R0), is defined to be close, if 1-\<3mm, and considered to be involved (R1), if \<1mm in the final specimen. Clearly defined marginal biopsies are required for each TOS-technique. Trans-oral re-resections are required in case of R1 or close-margin to convert the patient to an R0-status.Postoperative RT or chemo-RT will be given within 5-6 weeks of surgery in case of positive. ARM 2: Radiotherapy Intensity modulated radiation therapy (IMRT) with Simultaneous integrated boost (SIB) will be applied to all patients in this arm. PTV prescription to tumor and high risk areas will be delivered daily for 5 days per week to a total dose of 66-70Gy in 2 Gy/fraction over 6 weeks, elective/prophylactic mucosal and nodal areas will receive a total dose of 54.25- 54.45 Gy in 33-35 fractions of 1.55-1.65 Gy over 6 weeks.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Universitaetklinikum Halle - Martin Luther Universitaet, Halle, , Germany

Universitaets Krankenhaus Eppendorf - UKE - University Cancer Center, Hamburg, , Germany

Universitaetsklinikum Jena, Jena, , Germany

Universitaetsklinikum Koeln, Koeln, , Germany

Staedtisches Klinikum Leipzig - Klinikum St Georg, Leipzig, , Germany

Universitaetsklinikum Leipzig, Leipzig, , Germany

Klinikum Rechts der isar Der Technische Universitaet Muenchen, Muenchen, , 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, Poznań, , 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, Zürich, , 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

Contact Details

Name: Christian Simon

Affiliation: Centre Hospitalier Universitaire Vaudois

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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