JPRN-jRCTs031180121进行中（未招募）3 期
JCOG1403: Phase III trial of a single early intravesical instillation of pirarubicin in the prevention of bladder recurrence after nephroureterectomy for upper tract urothelial carcinoma - UTUC THP Phase III
ITO Akihiro0 个研究点目标入组 310 人开始时间: 2019年2月13日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 310
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •First registration
- •1. Upper tract urothelial carcinoma located primarily in the renal pelvis or the ureter with fulfilling all of the followings:
- •i) clinically diagnosed with enhanced CT imaging or with urographic imagingor ureteroscopy in the difficult case of diagnosing with enhanced CT imaging
- •ii) without requiring histological diagnosis
- •iii) not bilateral
- •iv) solitary or multiple tumors
- •2. Clinical stage 0a-III(cTa-T3N0M0)diagnosed by CTimaging.
- •3. Aged 20 to 80 years old.
- •4. ECOG performance status (PS) of 0 or 1.
- •5. No prior treatment for upper tract urothelial carcinoma.
- •6. No bladder cancer diagnosed by cystoscopy.
- •7. No history of bladder cancer.
- •8. No history of irradiation including the bladder.
- •9. The kidney located on the opposite side of the upper tract urothelial carcinoma is functioning..
- •10. Sufficient organ functions.
- •11. Written informed consent.
- •Second registration
- •1. Macroscopically proven cTa-3N0M0 in the intraoperative findings or in the extirpated specimens
- •2. No lymph node metastasis if pathological examination during surgery is conducted.
- •3. No serious intraoperative complications those interfere the protocol.
- •4. No leak after bladder wall resection of the ureteral orifice site.
- •5. Resection margin of the ureter is macroscopically negative.
- •6. Within 56 days from the date of cystoscopy.
- •7. Within 91 days from the date of CT.
- •8. Urine cytology is performed once if it is positive, or three times if it is negative or false positive
排除标准
- •First registration (no exclusion criteria at second registration)
- •1. Synchronous or metachronous (within 5 years) malignancies.
- •2. Infectious disease requiring systemic treatment.
- •3. Pyrexia of 38 degrees centigrade or higher.
- •4. Female during pregnancy, within 28 days of postparturition, or during lactation
- •5. Severe psychological disorder.
- •6. Receiving continuous systemic corticosteroid or immunosuppressant treatment.
- •7. History of abnormal cardiac function or having received the limit dose of medications with cardiac toxicity such as anthracyclines.
- •8. Positive HIV antibody.
研究者
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