EUCTR2013-001062-41-DE进行中（未招募）1 期
eoadjuvant chemotherapy with Cabazitaxel in high risk prostate cancer patients prior to radical prostatectomy - Neoadjuvant Study
RWTH Aachen University, represented by the Rector, himself represented by Clinical Trial Center (CTC-A)0 个研究点目标入组 35 人开始时间: 2013年4月19日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
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
- Male
入选标准
- •Surgically resectable high risk prostate cancer with a 5-year relapse probability = 60% according to the Kattan pre-operative nomogram (cancer 2009, 115: 1005-1010)
- •no prior therapy for prostate cancer such as androgen deprivation therapy, radiation therapy, or chemotherapy
- •ECOG performance status 0-1
- •No evidence of active infection
- •Hemoglobin >9.0 g/dL
- •Absolute neutrophil count >1.5 x 109/L,
- •Platelet count >100 x 109/L,
- •AST/SGOT and/or ALT/SGPT <2.5 x ULN;
- •Total bilirubin <1.0 x ULN,
- •Serum creatinine <1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance <60 mL/min should be excluded)
- •Patient information and signature of informed consent
- •Male = 18 years
- •Patients of reproductive age must take appropriate contraceptive precautions during and for 6 months after the end of their participation in 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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Evidence of lymph node, visceral or bone metastases
- •previous major intrapelvic surgery
- •previous radiation therapy to the small pelvis
- •any type of malignancies within the last 5 years except basalioma and non-muscle invasive urothelial cancer of the urinary bladder
- •previous chemotherapy with taxanes (docetaxel, paclitaxel, cabazitaxel) for any indication
- •Hypersensitivity to the active substance or to any of the excipients
- •Known or suspected brain metastases or leptomeningeal metastases
- •Active or symptomatic viral hepatitis or chronic liver disease
- •Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
研究者
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