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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hippocampal sparing radiotherapy | Experimental | Radiation according to indication with hippocampal sparing |
|
| Control | Active Comparator | Radiation according to indication without hippocampal sparing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation according to indication with hippocampal sparing | 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 |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rainer Fietkau, MD | Contact | ++49(0)9131 85 | 33968 | st-studiensekretariat@uk-erlangen.de |
| Godehard Lahmer, MD | Contact | ++49(0)9131 85 | 33968 | godehard.lahmer@uk-erlangen.de |
| Name | Affiliation | Role |
|---|---|---|
| Rainer Fietkau, MD | Strahlenklinik, Universitätsklinikum Erlangen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Erlangen | Recruiting | Erlangen | 91054 | Germany |
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|
| Radiation according to indication without hippocampal protection | 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 |
|
| ID | Term |
|---|---|
| D008579 | Meningioma |
| D010911 | Pituitary Neoplasms |
| D001932 | Brain Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009383 | Neoplasms, Vascular Tissue |
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D007029 | Hypothalamic Neoplasms |
| D015173 | Supratentorial Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D007027 | Hypothalamic Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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