Radiation of Neurocranial Region Clinical Trial
Official title:
Effect of Hippocampal Sparing on Neurocognitive Functions and Quality of Live in Patients Irradiated in the Neurocranial Area
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 hippocampus has a crucial role in regard to neurocognition and memory,
hippocampal region has been relatively disregarded in radiotherapy of neurocranium so far.
Brain metastases in the hippocampal region are very rare and an infiltration of the
hippocampus by meningioma or by pituitary adenoma just occurs when volume of the tumor is
very high. This study aims to reduce the radiation dose in the hippocampal region to improve
the quality of live and neurocognitive functions in patients without degrading prognosis or
increasing probability of brain metastases in hippocampal region.
Primary endpoint of the trial is quality of live and neurocognitive functions in patients
after radiation of neurocranial region with hippocampal sparing compared with conventional
radiotherapy of the neurocranial region without hippocampal sparing. Secondary endpoints are
cerebral recurrence rate in hippocampal region and overall survival. It is planned to
include a total number of 150 patients.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment