Enhancement of Neurocognitive Functions by Hippocampal Sparing Radiotherapy

University of Erlangen-Nürnberg Medical School150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Radiation of Neurocranial Region

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

Enhancement of Neurocognitive Functions by Hippocampal Sparing Radiotherapy

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts