Radiation of Neurocranial Region
Conditions
Keywords
meningioma, skull base meningioma, pituitary adenoma, brain metastases, small cell lung carcinoma
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.
Interventions
RADIATIONRadiation 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
RADIATIONRadiation 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
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany
Contacts
Primary ContactRainer Fietkau, MD
Backup ContactGodehard Lahmer, MD
Outcome results
None listed