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Effect of Hippocampal Sparing on Neurocognitive Functions and Quality of Live in Patients Irradiated in the Neurocranial Area


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Radiation of Neurocranial Region

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Trial Information

Effect of Hippocampal Sparing on Neurocognitive Functions and Quality of Live in Patients Irradiated in the Neurocranial Area


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 ‚Č• 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

quality of live and neurocognitive functions

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Rainer Fietkau, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Strahlenklinik, Universitätsklinikum Erlangen

Authority:

Germany: Ethics Commission

Study ID:

HIPSPA2013

NCT ID:

NCT01849484

Start Date:

March 2013

Completion Date:

April 2021

Related Keywords:

  • Radiation of Neurocranial Region
  • meningioma
  • skull base meningioma
  • pituitary adenoma
  • brain metastases
  • small cell lung carcinoma

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