CTIS2024-513248-27-00招募中1 期
Multicentre, randomized, controlled, open-label, multi-centre medicoeconomic study evaluating the efficacy of adding zoledronic acid or denosumab to Stereotaxic radiotherapy in the treatment of vertebral metastases (ZOSTER) - ZOSTER ICO-N-2018-14
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 202
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+(—)
- 性别
- All
入选标准
- •Cancer with inoperable thoracic and/or lumbar vertebral metastases, Age = 18 years, Life expectancy greater than 1 year, WHO or PS = 2, Effective contraception for women of childbearing age, Informing the patient and obtaining free, informed and written consent, signed by the patient and the investigator, Patient affiliated to or benefiting from the social security system
排除标准
- •Painful patient unable to maintain a supine position for 30 minutes despite analgesic treatment;, Patient under guardianship or unable to give consent;, Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons., Previous treatment with desonumab within the last 6 months or ongoing at inclusion., Patients with severe untreated hypocalcaemia., suppressed, Signs of neurological compression, Spinal cord compression or epidural involvement requiring surgery prior to radiotherapy;, Clinically significant hypersensitivity to zoledronic acid or denosumab, other bisphosphonates or any excipient;, A history of osteonecrosis of the jawbone or exposed bone or delayed healing after dental surgery;, Previous bisphosphonate treatment within the last 24 months or ongoing at inclusion;, Creatinine clearance < 30 ml/min;, Pregnant or breast-feeding woman;
研究者
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