Sponsor study identifier
interventional
150
1 country
1
Study Start
March 2013
Actual (reported)Primary Completion
March 2024
Actual (reported)Study Completion
April 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2013
Actual (reported)May 3, 2013
Actual (reported)May 8, 2013
Actual (reported)March 2024
Actual (reported)April 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
quality of live and neurocognitive functions
Participants will be followed for the duration of therapy and for 5 years after the last study treatment
cerebral recurrence rate in hippocampal region
Participants will be followed for the duration of therapy and for 5 years after the last study treatment
overall survival
Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Radiation according to indication with hippocampal sparing
Radiation according to indication without hippocampal sparing
Performed with hippocampal sparing Meningioma-total dose up to 50.4 Gy (+ additional boost up to 59.4 Gy) Hypophyseal adenoma - total dose up to 50.4 Gy (+additional boost up to 54 Gy) SCLC (prophylactic cranial irradiation) - total dose up to 36.0 Gy
Performed with hippocampal sparing Meningioma-total dose up to 50.4 Gy (+ additional boost up to 59.4 Gy) Hypophyseal adenoma - total dose up to 50.4 Gy (+additional boost up to 54 Gy) SCLC (prophylactic cranial irradiation) - total dose up to 36.0 Gy
Universitätsklinikum Erlangen
Erlangen, 91054, Germany
Rainer Fietkau, MD
Strahlenklinik, Universitätsklinikum Erlangen
First Submitted
May 3, 2013
First Posted
May 8, 2013
Study Start
March 2013
Actual (reported)Primary Completion
March 2024
Actual (reported)Contact the study team to confirm eligibility.
Study Completion
April 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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