ACTRN12617001612303招募中1 期
A phase I/II study to evaluate the safety and efficacy of injection of Bromelain and Acetylcysteine in combination into recurrent mucinous tumour or pseudomyxoma peritonei and aspiration of tumour
Professor David Morris0 个研究点目标入组 60 人开始时间: 2017年12月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Patients with PMP or mucinous tumour who are not candidates for CRS/HIPEC or other surgery, have soft to intermediate grade tumour and do not meet any exclusion criteria
- •Patients will be considered for entry into this study if they:
- •Are 18 – 80 years old
- •Have a mucinous tumour or pseudomyxoma peritonei (target or free intraperitoneal) as identified on prior histology
- •Are considered at high risk for repeat surgery, or do not wish to explore repeat surgery and consent to the trial procedures
- •Have soft to intermediate grade tumour as identified on prior histology or operation
- •Are considered suitable for the trial based on multidisciplinary team meeting review
- •Tumour should not be hard tumour or caking and have a clear cystic or mucinous appearance as identified on radiology. Having hard tumour in one region does not exclude treatment in another area, provided the appearance is mucinous.
- •In the case of a target lesion, tumour located elsewhere will not exclude a patient from this study and these tumours may be treated if suitable. The tumour must be safely accessible percutaneously by an interventional radiologist to allow insertion of a catheter or drain
排除标准
- •Exclusion criteria
- •Patients will be excluded from the study if they:
- •Have a non-mucinous tumour recurrence (hard tumour)
- •Have suspected fistulisation of the tumour into the gastrointestinal tract, invading or abutting major vessel or other area of concern
- •Have an allergy to pineapples, papain or bromeliads, sulphur or Acetylcysteine (skin tests will be performed in any patient where allergy or sensitivity is unknown)
- •Have a coagulation disorder of any kind or are on anticoagulant or anti-platelet therapy that can not be managed or withheld for the treatment period
- •Are asthmatic
- •Have infected tumour (pus on aspiration or indicated on blood test)
- •Have other serious comorbidities where inclusion in the trial will subject the patient to a higher risk of adverse events
- •Are unable to give fully informed and educated consent or are unable to comply with the standard follow up procedures of a clinical trial
- •Considered by the interventional radiologist to not be percutaneously accessible
研究者
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