A Multicenter Prospective Randomized Controlled Clinical Trial of Hyperthermic Intravesical Chemotherapy After Transurethral Resection of Bladder Tumors in Patients With Non-Muscle-Invasive Bladder Cancer
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 320
- 主要终点
- Recurrence rate
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of Hyperthermic Intravesical Chemotherapy (HIVEC) with Gemcitabine (GEM) after Transurethral Resection of Bladder Tumors (TURBT) in the treatment of medium or high-risk group Non-Muscle-Invasive Bladder Cancer (NMIBC).
详细描述
In this study, patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) and planed to undergo Transurethral Resection of Bladder Tumors (TURBT) are randomized into HIVEC group and control group. In HIVEC group, HIVEC is performed with Gemcitabine Gemcitabine (3g/150ml NS) at 45 °C for 60 minutes within 4 weeks, once a week (±5 days) for 6 to 8 times, once a month to 1 year. For the patients in the control group, Intravesical Chemotherapy is administered after TURBT. The primary endpoint is 2-year recurrence rate. Secondary end points include 1-year recurrence rate, recurrence-free survival (RFS) rate, disease free survival (DFS) rate, time to treatment failure (TTF), Success rate of therapeutic operation, Instrument performance evaluation, quality of international prostate symptom score, quality of Urinary Symptoms Distress Score. All efficacy analyses are conducted in the intention-to-treat population. Safety analysis include only patients who receive their randomly assigned treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who did not receive induction perfusion within 4 weeks after complete resection of bladder tumor with TURBT (Patients who were judged by the investigator to be in need of secondary electrotomy, for the last time).
- •Recurrence risk and prognosis of Non-Muscle-Invasive Bladder Cancer were divided into medium-risk group or high-risk group (patients who underwent multiple electrosurgical biopsies, and the pathological results were based on higher grade tumors).
- •KPS score ≥80, expected survival > 30 months.
- •Pathological suggested non-myoinvasive urothelial carcinoma of the bladder.
- •Age between 18 and 70 years, all genders.
- •Volunteer to participate in this clinical trial and written informed consent.
排除标准
- •Patients with bladder cancer in situ.
- •Combined with proven upper urinary tract or urethral tumors.
- •The patients were complicated with bladder perforation, gross hematuria or urinary tract infection of grade 3-
- •Patients with urethral discontinuity, urethral stricture, or inability to use a three lumen catheter normally affect perfusion therapy.
- •Patients who had undergone partial cystectomy or abnormal bladder structure were judged by the investigator to be unsuitable for perfusion therapy.
- •Patients with severe coagulation dysfunction.
- •A history of allergy to injected drugs (gemcitabine).
- •History of pelvic radiation, systemic chemotherapy, or immunotherapy.
- •Complicated with cardiovascular, cerebrovascular, hematopoietic, immune system and other serious diseases.
- •Patients with mental illness, substance abuse, alcoholism, and inability to cooperate.
- •Breastfeeding, pregnant, or planning to have a baby in the near future.
- •Recurrent patients with a prior history of BCG or bladder thermoperfusion therapy.
- •Participated in other clinical trials 1 month before the trial.
- •Vesicoureteral regurgitation.
- •The investigator considered it inappropriate to participate in this clinical trial.
研究组 & 干预措施
Matched control
Patients undergo Transurethral Resection of Bladder Tumors (TURBT) and receive Intravesical Chemotherapy.
干预措施: TURBT (Procedure)
Matched control
Patients undergo Transurethral Resection of Bladder Tumors (TURBT) and receive Intravesical Chemotherapy.
干预措施: Intravesical Chemotherapy (Procedure)
Matched control
Patients undergo Transurethral Resection of Bladder Tumors (TURBT) and receive Intravesical Chemotherapy.
干预措施: Gemcitabine (Drug)
HIVEC
Patients undergo Transurethral Resection of Bladder Tumors (TURBT) and Hyperthermic Intravesical Chemotherapy (HIVEC)
干预措施: TURBT (Procedure)
HIVEC
Patients undergo Transurethral Resection of Bladder Tumors (TURBT) and Hyperthermic Intravesical Chemotherapy (HIVEC)
干预措施: HIVEC (Procedure)
HIVEC
Patients undergo Transurethral Resection of Bladder Tumors (TURBT) and Hyperthermic Intravesical Chemotherapy (HIVEC)
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Recurrence rate
时间窗: 2-year
The patients were observed for 2 years since they received HIVEC or intravesical chemotherapy，and cystoscopy was repeated every 3 months. If a new tumor-like organism is seen under the microscope, and pathology indicates urothelial carcinoma of the bladder after TURBT or cystoscopic biopsy, the tumor is considered to have recurred. 2-year recurrence rate = number of recurrence cases within 2 years / total number of enrolled cases \* 100%.
次要结局
- Time to treatment failure(2-year)
- Success rate of therapeutic operation(2-year)
- Quality of bother of score(Evaluation was performed during the screening period and at 3, 12 and 24 months after initiation of treatment)
- Recurrence-free survival (RFS) rate(2-year)
- 1-year recurrence rate(1-year)
- Quality of international prostate symptom score(Evaluation was performed during the screening period and at 3, 12 and 24 months after initiation of treatment.)