Trial document





This trial has been registered retrospectively.
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  DRKS00009357

Trial Description

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Title

Stereotactic fractionated radiotherapy of the resection cavity as adjuvant treatment after resection of brain metastases

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

For the therapy of brain metastasis the radiotherapy plays an important role. In the past, there was the indication for a whole brain irradiation after the surgery. This treatment was considered as standard to ensure the local and distant tumor control. By this means it was intended to act against minor and macroscopic tumor remnants. Adverse effects can follow the whole brain irradiation, which can restrict the cognitive and physical function of the patients. For this reason, this method has been discussed conversely again and again in the last years. A study of the EORTC (European Organisation for Research and Treatment of Cancer) has compared the localized therapy (resection or radiosurgery) with a more extensive therapy (resection or radiosurgery and adjuvant whole brain irradiation). There it was shown that the whole brain irradiation has no influence on the overall survival. Therefore the role of the whole brain irradiation was put into question and the focus put on the localized therapy. Objective of this study is to improve the local tumor control after the surgery of solitary (1-3) brain metastases and with this to develop a new concept for the therapy. For this reason the local and distant tumor control as well as the survival of the patients with 1-3 brain metastases who received an adjuvant stereotactic fractionated irradiation, will be evaluated retrospectively.

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Brief Summary in Scientific Language

In this study it shall be investigated whether an irradiation of the resection cavity by fractionated stereotactic radiotherapy will lead to a low rate of local relapse and a good distant tumor control. By means of a literature evaluation these criteria will be compared to the whole brain irradiation.

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Organizational Data

  •   DRKS00009357
  •   2015/10/22
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  •   yes
  •   Approved
  •   482/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   C71 -  Malignant neoplasm of brain
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Interventions/Observational Groups

  •   For patients with 1-3- brain metastases who received an adjuvant stereotactic fractionated radiotherapy, the local and distant tumor control and the survival will be investigated retrospectively.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   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

Local tumor control

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Secondary Outcome

distant tumor control. Survival of patients with 1-3 brain metastases.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/11/22
  •   70
  •   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

patients with 1-3 brain metastases of a solid tumor where the indication for a whole brain irradiation existed, treatment by fractionated stereotactic irradiation after successful resection of the brain metastases

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Exclusion Criteria

Germ cell tumors, lymphomas

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Addresses

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    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Ms.  Prof. Dr. med.  Anca Ligia  Grosu 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Ms.  Prof. Dr. med.  Anca Ligia  Grosu 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Ms.  Angelika  Bilger 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/11/30
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.