NL-OMON44854已完成不适用
Watchful waiting in patients with good and intermediate risk metastatic renal cell carcinoma; an imaging guided observational approach - IMPACT - Renal Watch
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Able to provide written informed consent
- •- Age >= 18 years
- •- Histological or cytological documented RCC with a clear cell component
- •- Good or intermediate prognosis, defined as none (good risk) or 1-2 (intermediate risk) of the below mentioned risk factors (6):
- •o Karnofsky performance <80
- •o Time from diagnosis detection of metastases < 1 year
- •o Haemoglobin < lower limit of normal (LLN)
- •o Corrected calcium > upper limit of normal (ULN)
- •o Neutrophils > ULN
- •o Platelets > ULN
- •- A watchful waiting period for 2 months is considered an option according to treating medical oncologist
- •- No prior systemic treatment for RCC (also non-adjuvant)
排除标准
- •- Untreated central nervous system metastases, or symptomatic intracerebral metastases.
- •- Pregnant or breast feeding women.
- •- Any serious and/or unstable pre-existing medical, psychiatric, or other condition that would make the subject inappropriate for study participation including any serious condition that could interfere with subject*s safety, provision of informed consent, or compliance with study procedure.
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