Effect of Hippocampal Sparing on Neurocognitive Functions and Quality of Live in Patients Irradiated in the Neurocranial Area
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- quality of live and neurocognitive functions
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control
Radiation according to indication without hippocampal sparing
干预措施: Radiation according to indication without hippocampal protection (Radiation)
hippocampal sparing radiotherapy
Radiation according to indication with hippocampal sparing
干预措施: Radiation according to indication with hippocampal sparing (Radiation)
结局指标
主要结局
quality of live and neurocognitive functions
时间窗: Participants will be followed for the duration of therapy and for 5 years after the last study treatment
次要结局
- 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)