DRKS00015647招募中3 期
Efficacy and Safety of Fractionated Stereotactic Radiation Therapy (FSRT) versus Single Fraction Stereotactic Radiosurgery (SRS) for Large Brain Metastases (2 - 4 cm) - FSRT-Trial
niversitätsklinikum Erlangen0 个研究点目标入组 382 人开始时间: 2018年10月5日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 382
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
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Age = 18 years (no upper age limit)
- •2. Karnofsky Performance Scale (KPS) score >50
- •3. Life expectancy > 3 months
- •4. 1 to 10 brain metastases from a solid tumor
- •5. Indication for local radiotherapy of one or more brain metastases measuring 2 to 4 cm in diameter
- •6. Ability to understand the contents of the protocol and consent to participate, in writing
- •7. Written informed consent before enrollment in the study
排除标准
- •1. Whole brain radiotherapy completed = 6 weeks before study treatment or planned whole brain radiotherapy following local radiotherapy
- •2. Prior radiotherapy of the metastasis or metastases to be irradiated in the present study
- •3. Relevant overlap of prior radiotherapy fields, cerebral or otherwise, with the metastasis or metastases to be irradiated in the present study
- •4. Location of metastasis to be irradiated in the brainstem.
- •5. Contraindications to magnetic resonance imaging (e.g., metal implants, cardiac pacemaker, claustrophobia)
- •6. If a metastasis to be irradiated cannot be adequately differentiated in high-resolution, contrast-enhanced T1-weighted imaging for target volume delineation
- •7. Pregnant or nursing women
- •8. Women and men of reproductive age who are unwilling or unable to ensure reliable contraception during treatment
- •9. Chronic drug, medication or alcohol abuse
- •10. Psychological, familial, sociological, or geographical condition that would preclude study compliance
- •11. Nursing care patients
- •12. Inability to speak and understand German
- •13. Simultaneous participation in another clinical trial
研究者
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