Status:

UNKNOWN

Enhancement of Neurocognitive Functions by Hippocampal Sparing Radiotherapy

Lead Sponsor:

University of Erlangen-Nürnberg Medical School

Conditions:

Radiation of Neurocranial Region

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

This randomized trial examines possible enhancements in live quality and neurocognitive functions in patients after radiotherapy of the neurocranial area with hippocampal sparing. Although the hippoca...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • minimum age 18
  • diseases indicating a radiotherapy of neurocranial area (histologically or image-guided confirmed (skull base)meningioma,pituitary adenoma,brain metastases, SCLC)
  • indication for a local radiotherapy in neurocranial area or for a radiation of whole neurocranium
  • Karnofsky-State ≥ 50%
  • patient has understand content of study protocol
  • Signed study-specific consent form prior to therapy
  • Exclusion Criteria
  • pregnant or nursing women
  • Fertile patients who refuse effective contraception during study treatment
  • persistent drug and/or alcohol abuse
  • prior radiotherapy of neurocranial region
  • patients not able or willing to behave according to study protocol
  • in the case of malignancy: more than 3 brain metastases
  • in the case of malignancy: brain metastases in hippocampal region or in the hippocampus avoidance zone
  • GTV in hippocampal region or in the hippocampus avoidance zone
  • patients in care
  • patients who are not able to speak German
  • conditions that preclude the application of MRT (e.g. magnetic implants, cardiac pacemaker)
  • on-treatment participation on other trials

Exclusion

    Key Trial Info

    Start Date :

    March 1 2013

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    April 1 2021

    Estimated Enrollment :

    150 Patients enrolled

    Trial Details

    Trial ID

    NCT01849484

    Start Date

    March 1 2013

    End Date

    April 1 2021

    Last Update

    August 1 2016

    Active Locations (1)

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    1

    Universitätsklinikum Erlangen

    Erlangen, Germany, 91054