NCT01849484Active, not recruitingPhase 2
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 · Last updated 27 Oct 2026
Brief summary (registry, in English)
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 (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 3 May 2013
- Start date
- 1 Mar 2013
- Primary completion date
- 31 Mar 2024
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Diseases
- Lung cancer
- NCT number
- NCT01849484
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 150
- From 1 Mar 2013 to the primary completion date, 31 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- persistent drug and/or alcohol abuse
- prior radiotherapy of neurocranial region
Other illness
- 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
- conditions that preclude the application of MRT (e.g. magnetic implants, cardiac pacemaker)
Other
- pregnant or nursing women
- Fertile patients who refuse effective contraception during study treatment
- patients not able or willing to behave according to study protocol
- GTV in hippocampal region or in the hippocampus avoidance zone
- patients in care
- patients who are not able to speak German
- on-treatment participation on other trials
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsklinikum Erlangen Coordinator of this site? Confirm its status | Erlangen | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.