To investigate whether rinsing the bladder with chemotherapy right before an operation that removes the kidney and ureter because of a malignant tumor is effective to reduce the risk of a subsequent bladder tumor

Recruiting

• Conditions: Bladder cancer (blaaskanker), chemotherapy (chemotherapie), nephro-ureterectomy (nefro-ureterectomie), upper urinary tract (hogere urinewegen), urothelial carcinoma (urotheelcelcarcinoom)

• Registration Number: NL-OMON24959
• Lead Sponsor: Erasmus university Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 170

Inclusion Criteria

Histologically proven urothelial carcinoma of the upper urinary tract with or without concurrent carcinoma in situ (CIS only is allowed) or patients with a suspicion of a urothelial carcinoma of the UUT on CT-scan plus a urinary cytology sample showing high-grade urothelial carcinoma;

-Patients planned to be treated either by partial ureterectomy or by a radical nephro-ureterectomy (open or laparoscopic) including a bladder cuff;

Exclusion Criteria

- If pre-operative histology by biopsy shows aberrant histology of the UUT tumor of >50% (adenocarcinoma, small cell carcinoma, squamous cell carcinoma).

- History or presence of a malignant tumor or carcinoma in situ of the bladder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The bladder cancer recurrence rate up to two years following surgery.

Secondary Outcome Measures

Name	Time	Method
- Compliance rate;<br /><br>- 2-year overall survival (OS), cancer-specific survival (CSS) and recurrence-free survival (RFS);<br /><br>- Toxicity of the regime (CTCAE);<br /><br>- Quality of life (EQ5D-5L, EORTC QLQ-C30);<br /><br>- Calculation of costs of a single neoadjuvant instillation with Mitomycin;<br /><br>- Molecular characterization of the upper urinary tract urothelial carcinoma and subsequent urothelial carcinoma of the bladder.