Trial document





This trial has been registered retrospectively.
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  DRKS00003829

Trial Description

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Title

Long-term results after radiotherapy of the vestibular schwannoma

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Trial Acronym

LTRVS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This is a retrospective study that asks about the success of two therapy modalities in patients with vestibular schwannomas who had a therapy on a vestibular schwannoma between June 1995 and March 2011. These modalities, stereotactic radiosurgery (SRS) and stereotactic fractionated radiotherapy (SFRT), should be compared and evaluated for the outcome of local control and the cranail nerve outcome for 78 patients between 28 and 93 years old. Additionally there was a questoinnaire sent to the patients with questions about their quality of life before and after therapy and about their personal satisfaction with the particular therapy. The long-term data should show, if there wouldn’t be any side effects after radiotherapy.

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Brief Summary in Scientific Language


This is a retrospective study that asks about the success of two therapy modalities in patients with vestibular schwannomas who had a therapy on a vestibular schwannoma between June 1995 and March 2011. These modalities, stereotactic radiosurgery (SRS) and stereotactic fractionated radiotherapy (SFRT), should be compared and evaluated for the long-term outcome of local control and cranail nerve outcome for 78 patients between 28 and 93 years old. Evaluation was done before and after radiotherapy for local control, hearing preservation, tinnitus, facial nerve and trigeminal nerve affection and dizziness/gait instability and vertigo. Additionally there was a questoinnaire sent to the patients containing questions about quality of life concerning their daily routine and job situation before and after radiotherapy, about improving or worsening (preexisting) nerve damages and about their personal satisfaction with the particular therapy. There was also a differenciation of the results depending from the height oft he applicated single dose (Gy), from neurofibromatosis-association, from preoperation or age.

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Organizational Data

  •   DRKS00003829
  •   2013/12/30
  •   [---]*
  •   yes
  •   Approved
  •   187/11, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   D33.3 -  Benign neoplasm: Cranial nerves
  •   H90 -  Conductive and sensorineural hearing loss
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Interventions/Observational Groups

  •   All patients who had stereotactic radiosurgery or fractionated stereotactic radiotherapy for a vestibular schwannoma between june 1995 and march 2011 at the Department of Radiation Oncology of the University Medical Center Freiburg were involved in the analysis of the data. All patients who were still alive received a written questionnaire and were contacted by telephone.
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The aim of the retrospective data evaluation was the additionally asked subjective opinion of the personal health of the patient days until years after therapy. here was the endpoint of the questoining by telephone and letter the evaluation of that information, that had to be answered and sent back until the 31th of december 2012. Important was not only the objective clinical outcome tested by scores, audiograms and radiology, but especially the personal feelings about the success of the therapy.

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Secondary Outcome

The updating of the patient's information was done until the 31th of april 2013.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2011/06/01
  •   78
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Diagnosis of a vestibular schannoma; therapy between June 1995 and March 2011

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Exclusion Criteria

at the same time cerebral metastases from a cancer

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Addresses

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    • Ärztliche DirektorinKlinik für StrahlenheilkundeRadiologische KlinikUniversitätsklinikum Freiburg
    • Ms.  Univ. Prof. Dr. med.  Anca-Ligia  Grosu 
    • Robert-Koch-Straße 3
    • 79106  Freiburg
    • Germany
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    • Klinik für StrahlenheilkundeRadiologische KlinikUniversitätsklinikum Freiburg
    • Ms.  Eva  Hermann 
    • Robert-Koch-Straße 3
    • 79106  Freiburg
    • Germany
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    • Klinik für StrahlenheilkundeRadiologische KlinikUniversitätsklinikum Freiburg
    • Ms.  Christina  Engelhard 
    • Robert-Koch-Straße 3
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Strahlenheilkunde
    • Ms.  Prof. Dr. med.  A.  Grosu 
    • Robert-Koch-STr. 3
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/03/05
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Trial Publications, Results and other Documents

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