Trial document




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  DRKS00004641

Trial Description

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Title

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

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Trial Acronym

SUPRATOL

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URL of the Trial

[---]*

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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 well-established surgical method in Germany.

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Brief Summary in Scientific Language

Since several years transoral laser microsurgery (TLM) has been established for supraglottic laryngectomy in supraglottic carcinomas in Germany. 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.

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Organizational Data

  •   DRKS00004641
  •   2015/02/24
  •   [---]*
  •   yes
  •   Approved
  •   A 149/14, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

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Health Condition or Problem studied

  •   C32 -  Malignant neoplasm of larynx
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Interventions/Observational Groups

  •   Transoral laser microsurgery (TLM) for supraglottic laryngectomy
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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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 treatment until grade <6 at penetration-aspiration-scale (PAS) according to Rosenbeck.

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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 tumor-related 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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2015/04/08
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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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

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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.

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Addresses

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    • Universitätsklinikum Schleswig-Holstein Campus Kiel
    • Arnold-Heller-Str. 3
    • 24105  Kiel
    • Germany
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    • Universität zu Kiel/UKSH Campus KielKlinik für HNO-Heilkunde, Kopf- und Halschirurgie
    • Ms.  Prof. Dr.  Petra  Ambrosch 
    • Arnold-Heller-Str. 3, Haus 27
    • 24105  Kiel
    • Germany
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    • Universität zu Kiel/UKSH Campus KielKlinik für HNO-Heilkunde, Kopf- und Halschirurgie
    • Ms.  Prof. Dr.  Petra  Ambrosch 
    • Arnold-Heller-Str. 3, Haus 27
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Krebsgesellschaft e.V. AHMO, Sektion B
    • Kuno Fischer Str. 08
    • 14057  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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