Spots Global Cancer Trial Database for Comparative Effectiveness Trial of Transoral Head and Neck Surgery Followed by Adjuvant Radio(Chemo)Therapy Versus Primary Radiochemotherapy for Oropharyngeal Cancer
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Trial Identification
Brief Title: Comparative Effectiveness Trial of Transoral Head and Neck Surgery Followed by Adjuvant Radio(Chemo)Therapy Versus Primary Radiochemotherapy for Oropharyngeal Cancer
Official Title: Comparative Effectiveness Trial of Transoral Head and Neck Surgery Followed by Adjuvant Radio(Chemo)Therapy Versus Primary Radiochemotherapy for Oropharyngeal Cancer
Study ID: NCT03691441
Conditions
Study Description
Brief Summary: Comparative Effectiveness Trial of Transoral Head and Neck Surgery followed by adjuvant Radio(chemo)therapy versus primary Radiochemotherapy for Oropharyngeal Cancer
Detailed Description: This trial investigates the effectiveness of transoral head and neck surgery (TOS) for locally advanced, but transorally resectable oropharyngeal cancer followed by risk-adapted adjuvant therapy versus primary radiochemotherapy (definitive chemoradiotherapy, CRTX). Both treatments are internationally accepted standards. The choice of the treatment strategy depends on the preference of the responsible attending physician and on the country of residence. Internationally, mostly definitive chemoradiotherapy is regarded as the standard of care for oropharyngeal cancer. In Germany, however, transoral surgical resection is also well established and commonly practiced. The key question therefore is whether one of the two therapies is more effective than the other in clinical daily routine under the given conditions of our health care system and with a realistic, non-ideal patient cohort. For this reason, a comparative effectiveness research (CER) concept will be applied in this setting. The aim of this trial is primarily to show a superiority of the surgical approach in terms of local and locoregional control and secondarily to compare functional outcome and quality of life.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Universitäts- HNO- Klinik Mannhein, Mannheim, Baden- Würtemberg, Germany
St. Vincentius- Kliniken Karlsruhe, Karlsruhe, Baden-Württemberg, Germany
Universitätsklinikum Ulm, Ulm, Baden-Württemberg, Germany
Helios Amper- Klinikum Dachau, Dachau, Bayern, Germany
Ruppiner Klinken GmbH, Neuruppin, Brandenburg, Germany
Klinikum Ernst von Bergmann gemeinnützige GmbH, Potsdam, Brandenburg, Germany
Universitätsklinikum Frankfurt, Frankfurt, Hessen, Germany
Universitätsklinikum Gießen, Gießen, Hessen, Germany
Philipps-Universität Marburg, Marburg, Hessen, Germany
Elbekliniken Stade- Buxtehude GmbH, Klinikum Stade und Klinik Dr. Hancken, Stade, Niedersachsen, Germany
Klinikum Wolfsburg, Wolfsburg, Niedersachsen, Germany
Kreiskliniken Gummersbach-Waldbröl GmbH Klinik Oberberg, Gummersbach, Nordrhein-Westfalen, Germany
Universitätsklinikum Köln, Köln, Nordrhein-Westfalen, Germany
Katholischen Krankenhaus Koblenz, Koblenz, Rheinland-Pfalz, Germany
Universität des Saarlandes, Homburg, Saarland, Germany
Universitätsklinik Leipzig / Borna Sana Kliniken Leipziger Land, Leipzig, Sachsen, Germany
Universitätsklinikum Schleswig-Holstein Campus Lübeck, Lübeck, Schleswig- Holstein, Germany
Universitätsklinikum Jena, Jena, Thüringen, Germany
Berlin Charité, Berlin, , Germany
Universitätsklinikum Hamburg Eppendorf, Hamburg, , Germany
Contact Details
Name: Chia-Jung Busch, PD Dr.
Affiliation: Universitätsklinikum Hamburg-Eppendorf
Role: PRINCIPAL_INVESTIGATOR
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