Radiation of Neurocranial Region Clinical Trial
— HIPPO-SPARE 01Official 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.
| Status | Recruiting |
| Enrollment | 150 |
| Est. completion date | April 2021 |
| Est. primary completion date | April 2021 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Universitätsklinikum Erlangen | Erlangen |
| Lead Sponsor | Collaborator |
|---|---|
| University of Erlangen-Nürnberg Medical School |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | quality of live and neurocognitive functions | Participants will be followed for the duration of therapy and for 5 years after the last study treatment | No | |
| Secondary | cerebral recurrence rate in hippocampal region | Participants will be followed for the duration of therapy and for 5 years after the last study treatment | Yes | |
| Secondary | overall survival | Participants will be followed for the duration of therapy and for 5 years after the last study treatment | No |