Clinical trial NCT01849484: Enhancement of Neurocognitive Functions by Hippocampal Sparing Radiotherapy
Official title: Effect of Hippocampal Sparing on Neurocognitive Functions and Quality of Live in Patients Irradiated in the Neurocranial Area
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Radiation of Neurocranial Region
Keywords: meningioma
skull base meningioma
pituitary adenoma
brain metastases
small cell lung carcinoma
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2013-05-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: cerebral recurrence rate in hippocampal region
timeFrame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment
measure: overall survival
timeFrame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
Study officials:
affiliation: Strahlenklinik, Universitätsklinikum Erlangen
name: Rainer Fietkau, MD
role: PRINCIPAL_INVESTIGATOR
References: