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Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 27, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT01849484). This is a study registration, not published results. Lead sponsor: University of Erlangen-Nürnberg Medical School. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 150 participants (ESTIMATED). Conditions: Radiation of Neurocranial Region. Interventions: RADIATION: Radiation according to indication with hippocampal sparing; RADIATION: Radiation according to indication without hippocampal protection. Primary outcome measures: quality of live and neurocognitive functions , Participants will be followed for the duration of therapy and for 5 years after the last study treatment. 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 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.