ACTRN12610000690055进行中（未招募）1 期
Pilot study of Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres (SIR-Spheres microspheres) in patients with Renal cell carcinoma.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 21
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 o limit（—）
- 性别
- All
入选标准
- •In order to be considered eligible for the study, patients must fulfil the following inclusion criteria:
- •(a) Willing, able and mentally competent to provide written informed consent.
- •(b) Histologically confirmed primary renal cell carcinoma of the kidney.
- •(c) Unequivocal and measurable MRI evidence of primary renal cell carcinoma that either:
- •1) is not suitable for treatment by surgical resection, local ablation or other conventional techniques with curative intent; or 2) does not require immediate treatment by surgical resection, local ablation or other conventional techniques with curative intent, at the time
- •of study entry.
- •(d) Metastatic disease other than untreated central nervous system (CNS) metastases is permitted.
- •(e) All imaging evidence used as part of the screening process must be less than 45 days old at the time of delivery of protocol SIRT therapy.
- •(f) Suitable for protocol therapy as determined by both the Medical Oncology and Surgical Urology Investigators.
- •(g) Other than radiotherapy, prior therapy for primary renal cell carcinoma is allowed, provided that such therapy was administered and completed at least 45 days prior to
- •entry into this study.
- •(h) World Health Organisation (WHO) performance status 0 – 2.
- •(i) Adequate haematological and renal function as follows:
- •Haematological Neutrophils > 1.5 x 109/L
- •Platelets > 100 x 109/L
- •Renal Calculated glomerular filtration rate (GFR) > 30 ml/min/1.73m2
- •(j) Aged 18 years or older.
- •(k) Female patients must be postmenopausal, or surgically sterile, or if sexually active using
- •an acceptable method of contraception.
- •(l) Male patients must be surgically sterile or if sexually active and having a pre-menopausal
- •female partner must be using an acceptable method of contraception.
- •(m) Life expectancy of at least 3 months without any active treatment.
- •(n) Renal arterial anatomy suitable for implantation of SIR-Spheres microspheres, as assessed by visceral and renal angiogram.
排除标准
- •Patients will be considered ineligible for the study for any of the following reasons:
- •(a) Previous radiotherapy delivered to the kidney or within a 5cm margin.
- •(b) Subsequent therapy planned to be administered within 60 days of the delivery of protocol SIRT therapy.
- •(c) Renal-to-lung shunt fraction that indicates potential exposure to the lung to an absorbed radiation dose of more than 25Gy.
- •(d) Inadequate renal function as defined by estimated GFR <30 ml/min/1.7m2.
- •(e) Intercurrent disease that would render the patient unsuitable for treatment according to this protocol.
- •(f) Equivocal, immeasurable, or unevaluable primary renal cell carcinoma in the kidney.
- •(g) Pregnant or breast feeding.
研究者
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