NCT00191477终止3 期
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Multicenter Study of Immediate Postoperative Instillation of Gemcitabine in Patients With Superficial Transitional Cell Carcinoma of the Bladder
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 355
- 试验地点
- 1
- 主要终点
- Recurrence-Free Survival (RFS)
研究概览
简要总结
A randomized, double-blind, placebo-controlled Phase 3 multicenter study to assess the efficacy and safety of intravesical instillation of gemcitabine versus placebo immediately after transurethral resection of the bladder tumor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical evidence of superficial transitional cell carcinoma of the bladder
- •Males or females at least 18 years of age
- •Karnofsky Performance Status greater than or equal to 70%
- •Patient compliance and geographic proximity that allow adequate follow-up
- •Female patients with reproductive potential must use a reliable contraceptive method if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) during the study. Female patients with reproductive potential must have a negative serum pregnancy test within 7 days of study enrollment.
- •Signed informed consent.
排除标准
- •Clinical evidence of muscle-invasive or locally advanced bladder cancer
- •Clinical evidence of upper urinary tract tumor
- •Distant metastases
- •Other malignancies within the last 2 years, except non-melanotic skin tumors, carcinoma in situ of the cervix or organ-confined prostate cancer after curative therapy
- •Severe concomitant psychiatric disease
- •Febrile, active infection
- •Other serious concomitant disorders that would compromise the safety of the patient or his/her ability to complete the study according to the protocol, at the discretion of the investigator (for example, unstable angina pectoris, uncontrolled diabetes mellitus)
研究组 & 干预措施
A
Experimental
干预措施: Gemcitabine (Drug)
B
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Recurrence-Free Survival (RFS)
时间窗: Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)
Defined as the time from study enrollment to the date of the first procedure confirming histopathological recurrence or disease progression or death from any cause. Recurrence-free survival (RFS) was censored at the date of the last follow-up visit for participants who were still alive and who had no recurrence/progression.
次要结局
- Time to Recurrence(Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months))
- Recurrence-Free Survival (RFS) in Subgroups(Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months))
- Tumor Recurrence Type(Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months))
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
3 期
Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's SyndromeSjogren SyndromeNCT05349214Novartis Pharmaceuticals506
招募中
3 期
A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE)Sickle Cell DiseaseNCT06439082Novartis Pharmaceuticals354
已完成
3 期
Phase III Study of Surufatinib in Treating Advanced Pancreatic Neuroendocrine TumorsNeuroendocrine TumorsNCT02589821Hutchison Medipharma Limited195
已完成
3 期
Phase III Study of Surufatinib in Treating Advanced Extrapancreatic Neuroendocrine TumorsNeuroendocrine TumorsNCT02588170Hutchison Medipharma Limited219
招募中
3 期
To Evaluate the Efficacy and Safety of LIZTOX in Subjects With Benign Masseteric HypertrophyBenign Masseteric HypertrophyNCT05964257Huons Biopharma168