ISRCTN45536692已完成未知
A double-blind randomised controlled trial (RCT) to assess the feasibility of giving Zoledronic acid alongside chemotherapy in patients with mesothelioma to design a larger trial to assess the efficacy of Zoledronic acid alongside first line chemotherapy
orth Bristol NHS Trust0 个研究点目标入组 22 人开始时间: 2016年8月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 22
研究概览
简要总结
2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30157910
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Histologically confirmed diagnosis of MPM
- •2. WHO performance status 0-1
- •3. Eligible for first line chemotherapy treatment Measurable disease on CT as per modified RECIST criteria (tumour thickness > 5mm)
- •4. Ability to give informed consent
- •5. Aged 18 years and over
排除标准
- •1. Not fit for chemotherapy due to performance status or other comorbidities Previous chemotherapy for MPM
- •2. IV bisphosphonates in the 3 months preceding randomisation
- •3. Significant renal disease (eGFR < 30ml/min in the last 4 weeks)
- •4. Hypocalcaemia (current hypocalcaemia on treatment, evidence of hypocalcaemia on most recent blood tests - should be within last 6 weeks)
- •5. Pregnancy or lactation Age
- •6. Age < 18 years
- •7. Known allergy to bisphosphonates or excipients of its preparation
- •8. Severe untreated dental caries
- •9. Concomitant participation in another drug trial for mesothelioma
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