Prospective multicenter study for functional evaluation of transoral laser microsurgery (TLM) for supraglottic carcinomas - SUPRATOL

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1 Trial Description Title Prospective multicenter study for functional evaluation of transoral laser microsurgery (TLM) for supraglottic carcinomas - SUPRATOL Trial Acronym SUPRATOL URL of the trial [---]* Brief Summary in Lay Language Aim of this study is to prepare a scientific examination of swallowing and voice function after TLM, an already established surgical method for the treatment of laryngeal carcinomas. In the last 10 years the transoral laryngeal partial resection with the laser (transoral laser microsurgery, TLM) has found broad application for the surgical treatment of supraglottic carcinomas, a tumor which occurs above the vocal folds in the larynx. Surgery is performed through the open mouth (transorally) and not by open partial resection, whereby the neck has to be opened and a routine tracheotomy has to be performed. Advantage of the transoral approach is the markedly reduced morbidity for the patient. In the long term the function of the laryngeal remnant, swallowing and voice, can be preserved very well. All patients taking part in this study will undergo TLM, a wellestablished surgical method in. Brief Summary in Scientific Language Since several years transoral laser microsurgery (TLM) has been established for supraglottic laryngectomy in supraglottic carcinomas in. In the literature good results have been reported but only in small monocentric and mainly retrospective studies. A randomized comparison with other treatment options (e.g. chemoradiation) is considered as not appropriate. This study should clarify whether the already reported positive results will be confirmed in a larger prospective multicenter study, in which all involved centers will include all suitable patients, which fulfill the inclusion and exclusion criteria, in a nonselective prospective way. Functional and oncological endpoints will be examined in the total study population, in defined subgroups and in single centers in descriptive way. Page 1 of 7

2 Organizational Data DRKS-ID: DRKS Date of Registration in Partner Registry or other Primary Registry: [---]* Investigator Sponsored/Initiated Trial (IST/IIT): yes Ethics Approval/Approval of the Ethics Committee: Approved (leading) Ethics Committee Nr.: A 149/14, Ethikkommission der Christian-Albrechts-Universität zu Kiel Secondary IDs Health condition or Problem studied ICD10: C32 - Malignant neoplasm of larynx Interventions/Observational Groups Arm 1: Transoral laser microsurgery (TLM) for supraglottic laryngectomy Characteristics Study Type: Interventional Study Type Non-Interventional: [---]* Allocation: Single arm study Blinding: [---]* Who is blinded: [---]* Control: Uncontrolled/Single arm Purpose: Treatment Assignment: Single (group) Phase: N/A Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): N/A Primary Outcome Time to aspiration-free swallowing after end of treatment, examined with FEES (fiberoptic endoscopic evaluation of swallowing), defined as time after end of Page 2 of 7

3 treatment until grade <6 at penetration-aspiration-scale (PAS) according to Rosenbeck. Secondary Outcome Local control, defined as time from study registration until local recurrence Larynx preservation Disease-specific survival, defined as time from study registration to tumorrelated death Overall survival, defined as time from study registration to death of any cause Dysphagia- and voice-related quality of life, recorded by MD Anderson Dysphagia Inventory (MDADI) and Voice-Handicap-Index (VHI) Complications of treatment Severe adverse events Tracheostomy temporary/permanent Necessity of PEG-feeding Countries of recruitment DE Locations of Recruitment University Medical Center Klinik für HNO-Heilkunde, Kopf- und Halschirurgie, Kiel University Medical Center Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde, Leipzig University Medical Center Klinik für Hals- Nasen- und Ohrenheilkunde, Lübeck Medical Center DIAKO Bremen, Klinik für Hals-, Nasen- und Ohrenheilkunde sowie plastische Kopf- und Halschirurgie, Bremen University Medical Center Hals-Nasen-Ohren- Klinik, Mannheim University Medical Center Hals-Nasen-Ohren-Klinik, Mainz Medical Center Klinik für Hals-, Nasen- und Ohrenheilkunde, Krefeld Medical Center Klinik für Hals-, Nasen-, Ohrenheilkunde, Schwerin Medical Center Hals-Nasen-Ohrenheilunde/Plastische Chirurgie, Suhl University Medical Center Klinik für Hals-Nasen-Ohrenheilkunde, Freiburg im Breisgau University Medical Center Klinik für Hals-Nasen-Ohrenheilkunde, Erlangen Medical Center Klinik für Hals-Nasen-Ohrenheilkunde, Dortmund Medical Center Klinik für HNO-Heilkunde und Kopf- und Halschirurgie, Düsseldorf Medical Center Klinikum der Stadt Ludwigshafen am Rhein, Ludwigshafen am Rhein Page 3 of 7

4 Medical Center Asklepios-Klinik St. Georg Hamburg, Halschirurgie, Plastische Chirurgie, Hamburg Medical Center Asklepios Klinik Hamburg-Altona, Halschirurgie, Plastische Chirurgie, Hamburg-Altona Medical Center Klinik für HNO, Kopf- und Halschirurgie, Aachepios Klinik Hamburg-Harburg Medical Center Helios Klinikum Erfurt, Klinik für HNO, Plastische Operationen, Erfurt Medical Center Medizinisches Zentrum für Gesundheit, Klinik für HNO-Heilkunde, Bad Lippspringe University Medical Center Klinik für HNO-Heilkunde, Regensburg University Medical Center Klinik für HNO Heilkunde, Münster Medical Center Klinik für HNO, Kopf- und Halschirurgie, Dessau-Roßlau University Medical Center Klinik und Poliklinik für HNO-Heilkunde, Würzburg University Medical Center Klinik und Poliklinik für HNO-Heilkunde, Halle Saale University Medical Center Klinik für HNO-Heilkunde, Jena University Medical Center Klinik für HNO-Heilkunde, Ulm University Medical Center Universitätsklinikum Großhadern (LMU), München Medical Center Vivantes Klinikum Neukölln, Berlin University Medical Center Universitätsklinikum des Saarlandes, Homburg/Saar Medical Center Karl-Thiem-Klinikum Cottbus, Cottbus Medical Center Klinikum Kassel, Kassel Medical Center Klinikum Augsburg Süd, Augsburg Medical Center Krankenhaus Dresden-Friedrichstadt, Dresden Medical Center St. Josefstift Bremen, Bremen University Medical Center Universitätsklinikum Magdeburg, Magdeburg Medical Center Ortenau-Klinikum Lahr, Lahr Medical Center Klinikum Bremen-Mitte, Bremen Medical Center Klinikum Ernst von Bergmann, Potsdam Recruitment Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment: 2015/04/15 Target Sample Size: 200 Monocenter/Multicenter trial: Multicenter trial National/International: National Inclusion Criteria Page 4 of 7

5 Gender: Both, male and female Minimum Age: 18 Years Maximum Age: no maximum age Additional Inclusion Criteria Histologically proven squamous cell carcinoma of the supraglottic larynx T2 and T3 tumor (UICC, 7th edition 2010) Stage II-IVb (UICC, 7th edition 2010) Age 18 years No pregnancy, reliable contraception during time of treatment Written informed consent Examination of swallowing function by FEES possible Exclusion criteria Tumor location outside the supraglottic larynx R0 resection of cervical lymph node metastases not possible Simultaneous distant metastases Simultaneous second primary tumor Previous malignant tumor, except basalioma and spinalioma of the skin and carcinomata in situ. Malignant tumor in patient s history with follow-up time less than 5 years. Patients without relapse within 5 years after therapy of a malignant tumor need consultation with the Principal Investigator. Previous local, regional or systemic tumor therapy. No suitability for general anesthesia. Not tumor-related swallowing disorder. Addresses Primary Sponsor Universitätsklinikum Schleswig-Holstein Campus Kiel Arnold-Heller-Str Kiel Telephone: [---]* Fax: [---]* [---]* URL: Page 5 of 7

6 Contact for Scientific Queries Universität zu Kiel/UKSH Campus KielKlinik für HNO-Heilkunde, Kopf- und Halschirurgie Ms. Prof. Dr. Petra Ambrosch Arnold-Heller-Str. 3, Haus Kiel Telephone: 0431/ Fax: 0431/ ambrosch at hno.uni-kiel.de URL: [---]* Contact for Public Queries Universität zu Kiel/UKSH Campus KielKlinik für HNO-Heilkunde, Kopf- und Halschirurgie Ms. Prof. Dr. Petra Ambrosch Arnold-Heller-Str. 3, Haus Kiel Telephone: 0431/ Fax: 0431/ ambrosch at hno.uni-kiel.de URL: [---]* Sources of Monetary or Material Support Private sponsorship (foundations, study societies, etc.) Deutsche Krebsgesellschaft e.v. AHMO, Sektion B Kuno Fischer Str Berlin Telephone: [---]* Fax: [---]* [---]* URL: [---]* Status Recruitment Status: Recruiting ongoing Study Closing (LPLV): [---]* Page 6 of 7

7 Trial Publications, Results and other documents This study is conducted in collaboration with the DSZ-HNO (German Clinical Trials Center for Otolaryngology and Head and Neck Surgery). Please note: There are additional attributes available concerning this trial. To open an extended view please click here.