DRKS00005269招募中2 期
eoadjuvant Chemotherapy with Cabazitaxel on patients with high risk Prostate Cancer prior to Radical Prostatectomy - ClubNet-CABAZ
Sanof Aventis Group, Paris0 个研究点目标入组 35 人开始时间: 2014年2月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 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 äs androgen deprivation therapy, radiation therapy, or chemotherapy
- •ECOG performance Status 0-1
- •ASA Status 1-2, Charslon comorbidity score 0-1
- •No evidence of active infection
- •Hemoglobin > 10.0 g/dL
- •Absolute neutrophil count >1.5 x 109/L,
- •Platelet count >100 x 109/L,
- •AST/SGOT and/or ALT/SGPT <1.5 x ULN;
- •Total bilirubin<1.0x 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
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
- •ASA Status 4
研究者
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