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

This study is currently recruiting participants.
Verified July 2016 by University of Erlangen-Nürnberg Medical School
Sponsor:
ClinicalTrials.gov Identifier:
NCT01849484
First Posted: May 8, 2013
Last Update Posted: August 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
  Purpose

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.


Condition Intervention Phase
Radiation of Neurocranial Region Radiation: Radiation according to indication with hippocampal sparing Radiation: Radiation according to indication without hippocampal protection Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Hippocampal Sparing on Neurocognitive Functions and Quality of Live in Patients Irradiated in the Neurocranial Area

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: March 2013
Estimated Study Completion Date: April 2021
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849484


Contacts
Contact: Rainer Fietkau, MD ++49(0)9131 85 ext 33968 st-studiensekretariat@uk-erlangen.de
Contact: Godehard Lahmer, MD ++49(0)9131 85 ext 33968 godehard.lahmer@uk-erlangen.de

Locations
Germany
Universitätsklinikum Erlangen Recruiting
Erlangen, Germany, 91054
Contact: Rainer Fietkau, MD    ++49(0) 9131 85 ext 33968    st-studiensekretariat@uk-erlangen.de   
Contact: Godehard Lahmer, MD    ++49(0) 9131 85 ext 33968    godehard.lahmer@uk-erlangen.de   
Principal Investigator: Rainer Fietkau, MD         
Sub-Investigator: Godehard Lahmer, MD         
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Principal Investigator: Rainer Fietkau, MD Strahlenklinik, Universitätsklinikum Erlangen
  More Information

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01849484     History of Changes
Other Study ID Numbers: HIPSPA2013
First Submitted: May 3, 2013
First Posted: May 8, 2013
Last Update Posted: August 1, 2016
Last Verified: July 2016

Keywords provided by University of Erlangen-Nürnberg Medical School:
meningioma
skull base meningioma
pituitary adenoma
brain metastases
small cell lung carcinoma