Enhancement of Neurocognitive Functions by Hippocampal Sparing Radiotherapy (HIPPO-SPARE 01)

July 29, 2016 updated by: University of Erlangen-Nürnberg Medical School

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Erlangen, Germany, 91054
        • Recruiting
        • Universitätsklinikum Erlangen
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rainer Fietkau, MD
        • Sub-Investigator:
          • Godehard Lahmer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hippocampal sparing radiotherapy
Radiation according to indication with hippocampal sparing
Radiation: Radiation according to indication with hippocampal sparing
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
Active Comparator: Control
Radiation according to indication without hippocampal sparing
Radiation: Radiation according to indication without hippocampal protection
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Participants will be followed for the duration of therapy and for 5 years after the last study treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Participants will be followed for the duration of therapy and for 5 years after the last study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

May 3, 2013

First Submitted That Met QC Criteria

May 3, 2013

First Posted (Estimate)

May 8, 2013

Study Record Updates

Last Update Posted (Estimate)

August 1, 2016

Last Update Submitted That Met QC Criteria

July 29, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HIPSPA2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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