Clinical trial · Interventional
Enhancement of Neurocognitive Functions by Hippocampal Sparing Radiotherapy
Effect of Hippocampal Sparing on Neurocognitive Functions and Quality of Live in Patients Irradiated in the Neurocranial Area
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation of Neurocranial Region | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation according to indication with hippocampal sparing | Radiation | — | UNRESOLVED |
| Radiation according to indication without hippocampal protection | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- hippocampal sparing radiotherapy
- description
- Radiation according to indication with hippocampal sparing
- interventionNames
- Radiation: Radiation according to indication with hippocampal sparing
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Radiation according to indication without hippocampal sparing
- interventionNames
- Radiation: Radiation according to indication without hippocampal protection
Primary outcomes (1)
- measure
- quality of live and neurocognitive functions
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available