Neoadjuvant Short-term Intensive Chemoresection Versus Standard Adjuvant Intravesical Instillations in NMIBC
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 2-year recurrence rate
研究概览
简要总结
A randomized controlled trial aiming to investigate neoadjuvant, short-term intensive chemoresection with Mitomycin C compared to standard treatment with TURB and adjuvant intravesical instillation therapy in patients with recurrent non-muscle invasive bladder cancer (NMIBC).
详细描述
Background:
Bladder cancer is the 11th most common cancer in the world and one of the most costly cancers on a per patient basis, due to the cost of operative procedures, follow-up cystoscopies and instillation therapy. Furthermore there is a risk of progression to invasive and hence deadly cancer why efficient and immediate treatment is crucial. Treatment today consists of surgical removal of tumours (TURB) and adjuvant intravesical treatment. There is a chance; neoadjuvant intravesical treatment with chemotherapy can supersede surgical removal in chemo-sensitive tumours while however some tumours will not respond to intravesical chemotherapy. Currently it is not possible to predict which tumours are chemo-sensitive and which are not.
Objectives:
To assess the efficacy of neoadjuvant, short-term intensive chemoresection with Mitomycin C compared to standard treatment with TURB and adjuvant intravesical instillation therapy in patients with recurrent non-muscle invasive bladder cancer (NMIBC).
To investigate the ability to predict chemo-response in patients with recurrent non-muscle invasive bladder cancer (NMIBC).
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
- None
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
- •Known history of urothelial non-invasive Ta-tumour low-grade or high-grade.
- •≥18 years old
- •Mentally healthy individual
- •The ability to understand Danish orally and in writing
排除标准
- •Known history of invasive tumour of the bladder (T1+)
- •Known history of CIS of the bladder
- •Previous BCG-treatment within the last 24 months
- •Previous Mitomycin C-treatment (except single-shot postoperative instillation)
- •Known allergy or intolerance to Mitomycin C
- •Solid tumour with suspicions of invasion
- •Single tumour of more than 2 cm in diameter
- •Suspicion of CIS (positive cytology with high-grade neoplastic cells combined with suspicious cystoscopy for flat lesions).
- •Small bladder volume (less than 100 ml) or incontinence
- •Acute cystitis
- •Pregnancy or breast-feeding
- •Not willing to use secure contraception with regard to men with partners and premenopausal women
研究组 & 干预措施
Intervention
Neoadjuvant Mitomycin C
干预措施: Mitomycin c (Drug)
Control
Adjuvant Mitomycin C
干预措施: Mitomycin c (Drug)
结局指标
主要结局
2-year recurrence rate
时间窗: within 2 years
The primary outcome is the number of patients in need for a TURB or tumour fulguration in the first 2 years following randomization. TURBs included as primary endpoint are the initial TURB in the control group, the prospective TURB in the intervention group for patients without complete chemoresection as well as TURB due to recurrence in both study groups. In case a TURB is recommended, but a subject refuses to undergo surgery, the recommended TURB is also registered.
次要结局
- 5-year recurrence rate(within 5 years)
- Tumour response rate(6 months after complete enrollment)
- Adverse events(6 months after complete enrollment)
- Biomarkers(within 2 years)
研究者
Jørgen Bjerggaard Jensen
Professor, MD
Aarhus University Hospital