EUCTR2015-002240-14-IT进行中（未招募）1 期
Targeted Therapy with or without Nephrectomy in Metastatic Renal Cell Carcinoma: Liquid Biopsy for Biomarkers Discovery - TARIBO
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 270
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age > 18 and < 75 years
- •Written informed consent
- •ECOG Performance Status 0-1
- •Favorable or intermediate MSKCC or Heng risk score
- •Biopsy (primary tumour or metastases) confirming the diagnosis of predominantly clear cell RCC
- •Resectable asymptomatic in situ primary (asymptomatic primary is defined as the absence of symptoms which can be exclusively assigned to the primary tumor such as flank pain and/or gross hematuria necessitating blood transfusion.)
- •Tumour suitable to nephrectomy in the opinion of the urologist. Patients with Inferior vena cava thrombosis can be included
- •Documented metastatic disease (CT scan or MRI)
- •Life expectancy > or = 24 weeks
- •Up to three different metastatic sites
- •= 3 metastatic lesions
- •Platelets = 100,000/ml
- •Haemoglobin = 9.0 g/dl
- •neutrophils >1,500/mm3
- •Bilirubin < or = 2 mg/dl, except for patients affected by Gilbert’s syndrome
- •AST and ALT < or = 2.5 times the UNL
- •Serum albumin = the LNL
- •Patients of childbearing age should use contraceptive methods during the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •Prior surgery or systemic treatment for mRCC
- •Bilateral RCC
- •Brain and liver metastases
- •Non-clear-cell histology
- •Poor prognosis as defined by MSKCC or Heng criteria
- •Documented widespread disease (> or =4 metastatic organ sites)
- •Oligometastatic disease suitable of metastasectomy (<3 lesions confined at one organ site)
- •Symptomatic primary tumour at presentation
- •High surgical risk in the opinion of the urologist
- •Patients with > 3 of the following surgical risk factors are not eligible:
- •-Serum albumin CTCAE v 4.0 grade 2 or worse
- •-Serum LDH > 1.5 times upper limit of normal
- •-Symptoms at presentation due to metastases
- •-Clinical stage T4 disease
- •- History of malabsorption syndrome
- •Pregnant or breastfeeding women
- •Concomitant cardiac disorders: cardiac failure NYHA> 2; Acute coronary syndrome or myocardial infarction or severe or unstable angina within the last 6 months as well as uncontrolled hypertension (sistolic>160, diastolic>90), arrhytmia requiring treatment (except for beta blockers or digossin)
- •Uncontrolled diabetes
- •Deep phlebitis not treated with LMWH or arterial thrombosis within the last 6 months
- •HIV infection
- •Active infections (> Grade 2 NCI-CTC v.3.0)
- •Patients with active bleeding or with pathological conditions increasing the risk of bleeding
- •Other cancer within the previous 5 years (except for in situ skin carcinoma, superficial bladder Ta, Tis, T1 and carcinoma of the cervix or every cancer with curative treatment within 5 years)
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