UnknownPhase 2

Enhancement of Neurocognitive Functions by Hippocampal Sparing Radiotherapy

Germany150 participantsStarted 2013-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

quality of live and neurocognitive functions

Timeframe: Participants will be followed for the duration of therapy and for 5 years after the last study treatment

Trial details

NCT IDNCT01849484

SponsorUniversity of Erlangen-Nürnberg Medical School

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-04

Contact for this trial

Rainer Fietkau, MD

++49(0)9131 85 st-studiensekretariat@uk-erlangen.de

View on ClinicalTrials.gov More Radiation of Neurocranial Region trials