Hippocampal Avoidance Whole Brain Radiotherapy (HA-WBRT) and Stereotactic Radiosurgery (SRS) in Patients With Multiple Brain Metastases
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Intracranial Progression free survival
研究概览
简要总结
This study compares the effectiveness and safety of two radiation treatment techniques for patients with multiple brain metastases.
详细描述
For patients suffering from multiple brain metastases whole brain radiation therapy still constitutes a standard therapy. However, because of the risk of neurocognitive side effects as well as reduced local tumor control, employment of stereotactic radiosurgery (SRS) is becoming more common. The disadvantage of SRS alone may be poor intracranial tumor control because of frequent appearance of new distant brain metastases after therapy. In recent years hippocampal avoidance whole brain therapy has been shown to minimize treatment related side effects while reducing the rate of distant intracranial failure.
In this study patients will be randomized to receive either hippocampal avoidance whole brain radiation therapy with integrated tumor boost (HA-WBRT+SIB) or stereotactic radiosurgery. The investigators hypothesize that HA-WBRT+SIB can improve intracranial tumor control compared to stereotactic radiosurgery, while avoiding additional neurocognitive side effects.
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
- Single (Care Provider)
盲法说明
Observer-blinding
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
- •At least 4 and not exceeding 15 brain metastases not exceeding a combined total volume of 25ml and not previously treated with radiotherapy
- •KPI ≥ 70, ECOG ≤ 2
- •Age ≥ 18 years, Male or female
排除标准
- •Neuroendocrine, SCLC, germinoma or lymphoma histology
- •Brain stem metastasis
- •Life expectancy < 3 months
- •Suspicion of meningeosis carcinomatosa
- •Previous WBRT
- •Inability to participate in radiologic follow-up, contraindication to MR imaging (e.g. not MRI compatible pacemaker, severe claustrophobia)
- •Inability to participate in neurocognitive function testing, insufficient German language skills, aphasia, graphomotor impairment, insufficient vision, insufficient attention span
- •Pregnancy, nursing or unwillingness to prevent pregnancy using effective methods of contraception during treatment
- •Known abuse of medication, drugs or alcohol
- •Known severe dementia (z-score < 2) or major cognitive function disorder that is not caused by intracranial tumour
- •Known clinical depression or psychotic disorder
结局指标
主要结局
Intracranial Progression free survival
时间窗: up to 18 months
survival with freedom from both local and distant intracranial progression, measured in months from end of treatment until progression or death, assessed in follow-up imaging (MRI, FET-PET)
次要结局
- Neurocognitive function assessed by VLMT(up to 18 months)
- Neurocognitive function assessed by TMT(up to 18 months)
- Quality of Life Score assessed by EORTC QLQ-C30 questionnaire(up to 18 months)
- Neurocognitive function assessed by COWAT(up to 18 months)
- Local control rate(up to 18 months)
- Survival time(up to 18 months)
- Quality of Life Score assessed by QLQ-BN20 questionnaire(up to 18 months)