Enhancement of Neurocognitive Functions by Hippocampal Sparing Radiotherapy

Phase 2

• Conditions: Radiation of Neurocranial Region
• Interventions: Radiation: Radiation according to indication with hippocampal sparing; Radiation: Radiation according to indication without hippocampal protection

• Registration Number: NCT01849484
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-05-03
• Study First Submitted QC: 2013-05-03
• Study First Posted: 2013-05-08
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-29
• Last Update Posted: 2016-08-01
• Primary Completion: 2021-04
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hippocampal sparing radiotherapy	Radiation according to indication with hippocampal sparing	Radiation according to indication with hippocampal sparing
Control	Radiation according to indication without hippocampal protection	Radiation according to indication without hippocampal sparing

Primary Outcome Measures

Name	Time	Method
quality of live and neurocognitive functions	Participants will be followed for the duration of therapy and for 5 years after the last study treatment

Secondary Outcome Measures

Name	Time	Method
cerebral recurrence rate in hippocampal region	Participants will be followed for the duration of therapy and for 5 years after the last study treatment
overall survival	Participants will be followed for the duration of therapy and for 5 years after the last study treatment

Trial Locations

Locations (1)

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany