Enhancement of Neurocognitive Functions by Hippocampal Sparing Radiotherapy

NCT ID: NCT01849484

Last Updated: 2016-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2021-04-30

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.

Conditions

Radiation of Neurocranial Region

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

hippocampal sparing radiotherapy

Radiation according to indication with hippocampal sparing

Group Type: EXPERIMENTAL

Radiation according to indication with hippocampal sparing

Intervention Type: RADIATION

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

Control

Radiation according to indication without hippocampal sparing

Group Type: ACTIVE_COMPARATOR

Radiation according to indication without hippocampal protection

Intervention Type: RADIATION

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

Interventions

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

Intervention Type: 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

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rainer Fietkau, MD

Role: PRINCIPAL_INVESTIGATOR

Strahlenklinik, Universitätsklinikum Erlangen

Locations

Universitätsklinikum Erlangen

Erlangen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Rainer Fietkau, MD

Role: CONTACT

st-studiensekretariat@uk-erlangen.de

++49(0)9131 85 ext. 33968

Godehard Lahmer, MD

Role: CONTACT

godehard.lahmer@uk-erlangen.de

++49(0)9131 85 ext. 33968

Facility Contacts

Rainer Fietkau, MD

Role: primary

st-studiensekretariat@uk-erlangen.de

++49(0) 9131 85 ext. 33968

Godehard Lahmer, MD

Role: backup

godehard.lahmer@uk-erlangen.de

++49(0) 9131 85 ext. 33968

Other Identifiers

HIPSPA2013

Identifier Type: -

Identifier Source: org_study_id