Radiation of Neurocranial RegionPhase 2HIPPO-SPARE 01NCT01849484
Enhancement of Neurocognitive Functions by Hippocampal Sparing Radiotherapy
A Phase 2 study testing Radiation according to indication with hippocampal sparing and Radiation according to indication without hippocampal protection in people with Radiation of Neurocranial Region, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
This randomized trial examines possible enhancements in live quality and neurocognitive functions in patients after radiotherapy of the neurocranial area with hippocampal sparing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation of Neurocranial Region
- What is being tested?
- Radiation according to indication with hippocampal sparing and Radiation according to indication without hippocampal protection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2013to Apr 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
- Conditions
- Radiation of Neurocranial Region
- Being tested
- Radiation according to indication with hippocampal sparing, Radiation according to indication without hippocampal protection
- Keywords
- meningioma, skull base meningioma, pituitary adenoma, brain metastases, small cell lung carcinoma
- Medical subject headings
- Meningioma, Pituitary Neoplasms, Brain Neoplasms, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation according to indication with hippocampal sparingRadiation
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
Radiation according to indication without hippocampal protectionRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| hippocampal sparing radiotherapy | Experimental | Radiation according to indication with hippocampal sparing Receives: Radiation: Radiation according to indication with hippocampal sparing |
| Control | Active comparator | Radiation according to indication without hippocampal sparing Receives: Radiation: Radiation according to indication without hippocampal protection |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of live and neurocognitive functions
Measured: Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Secondary outcomes (2)
cerebral recurrence rate in hippocampal region
Measured: Participants will be followed for the duration of therapy and for 5 years after the last study treatment
overall survival
Measured: Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2024
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation of Neurocranial RegionStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rainer Fietkau, MD, Principal investigator, Strahlenklinik, Universitätsklinikum Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849484
- Sponsor's protocol ID
- HIPSPA2013
- Acronym
- HIPPO-SPARE 01
- Status last verified
- Oct 2026
- First submitted
- 3 May 2013
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hippocampal Sparing on Neurocognitive Functions and Quality of Live in Patients Irradiated in the Neurocranial Area
- ClinicalTrials.gov ID
- NCT01849484
- Acronym / sponsor ID
- HIPPO-SPARE 01 / HIPSPA2013
- Conditions
- Radiation of Neurocranial Region
- Keywords
- meningioma, skull base meningioma, pituitary adenoma, brain metastases, small cell lung carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Mar 2024 (actual)
- Study completion
- Apr 2029 (estimated)
- First posted
- 8 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hippocampal sparing radiotherapy | Experimental | Radiation: Radiation according to indication with hippocampal sparingRadiation according to indication with hippocampal sparing |
| Control | Active comparator | Radiation: Radiation according to indication without hippocampal protectionRadiation according to indication without hippocampal sparing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation according to indication with hippocampal sparingPerformed 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 | Radiation | hippocampal sparing radiotherapy |
| Radiation according to indication without hippocampal protectionPerformed 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 | Radiation | Control |
Primary outcome
quality of live and neurocognitive functions
Time frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment
2 secondary outcomes
cerebral recurrence rate in hippocampal region
Time frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment
overall survival
Time frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer Fietkau, MD principal investigator
Strahlenklinik, Universitätsklinikum Erlangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation according to indication with hippocampal sparing and Radiation according to indication without hippocampal protection in people with Radiation of Neurocranial Region, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of live and neurocognitive functions (time frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.