DRKS00004598已完成2 期
Whole-brain irradiation with hippocampal sparing and dose escalation on metastases: neurocognitive testing and biological imaging - HIPPORAD
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 136
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. Patient's written informed consent has been obtained
- •2. Age 18-80 years, male or female
- •3. Legal capacity, patient is able to understand the nature, significance, and consequences of the trial
- •4. At least 4 brain metastases of solid tumours, with at least one, but not exceeding 10 metastases = 5mm (i.e. eligible for dose escalation)
- •5. RPA classification I or II
- •6. No metastases (either preirradiated or not) and no resection cavity within the hippocampus or in a distance of 7mm to the hippocampus (= hippocampal avoidance region, HAR)
排除标准
- •1. Simultaneous participation in other interventional trials which could interfere with this trial
- •2. Participation in a clinical trial within the last thirty days before the start of this trial, previous participation (randomisation) in this trial
- •3. Known or persistent abuse of medication, drugs or alcohol
- •4. Persons who are in a relationship of dependence/employment with the sponsor or the investigator
- •5. Pregnancy, nursing or patient not willing to prevent a pregnancy during treatment
- •6. Cerebral lymphomas, metastases of germ cell tumours, SCLC
- •7. Acute neurological symptoms demanding an immediate start of RT
- •8. CNS diseases or syndromes accompanied by cognitive deficits or radiological changes of the brain, e.g., dementia, major depression, clinically manifest hypertensive encephalopathy, meningiosis carcinomatosa
- •9. Previous brain irradiation (SRS/SFRT) of >1 brain metastasis >3cm or >3 brain metastases >1cm each
- •10. Previous brain irradiation <3 months before start of treatment
- •11. Previous surgical resection (± adjuvant SFRT) of >1 brain metastasis (biopsy allowed)
- •12. Previous surgical resection of 1 brain metastasis <4 weeks before start of treatment
- •13. Uncontrolled pretreated brain metastasis/-es after SRS/SFRT
- •14. Last application of chemotherapy/immunotherapy/targeted therapy <1 week before randomisation
- •15. RT planning conforming to OAR constraints not feasible (including previous cranial irradiation)
- •16. Benzodiazepines, barbiturates, topiramate, hydantoine as antiepileptic medication
- •17. > 1 brainstem metastasis =5mm
- •18. Brainstem metastasis >2cm
- •19. Brain metastasis >3.5cm
- •20. Resection cavity eligible for dose escalation >3.5cm
研究者
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