Testing Early Chemotherapy After Surgery for High-Risk Non-Muscle-Invasive Bladder Cancer
Tests chemotherapy given right after surgery in adults with high-risk bladder cancer.
Plain-language title generated from the registry record
Registry title: Immediate Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer
Key facts
- Where
- Shanghai, ChinaSee the site
Where in China
- Shanghai Changhai HospitalShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Changhai Hospital
- Trial code
- NCT06889623
- Record updated
- 21 March 2025
- Original description
Residual tumors after transurethral resection of bladder tumors (TURBT) range from 17-70%, and floating tumor cells from traditional segmental resection may lead to recurrence if they re-implant in the bladder wall. Immediate systemic chemotherapy post-surgery aims to eliminate microlesions promptly and minimize recurrence risk, yet its safety and efficacy require further exploration. This prospective, single-arm study delves into evaluating the efficacy and safety of immediate postoperative systemic chemotherapy in patients with suspected high-risk non-muscle-invasive bladder cancer.Read full original descriptionShow less
Impact of Immediate Cisplatin/Gemcitabine Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer: an Open-label, Single-arm, Prospective Trial
Residual tumors after transurethral resection of bladder tumors (TURBT) range from 17-70%, and floating tumor cells from traditional segmental resection may lead to recurrence if they re-implant in the bladder wall. Immediate systemic chemotherapy post-surgery aims to eliminate microlesions promptly and minimize recurrence risk, yet its safety and efficacy require further exploration. This prospective, single-arm study delves into evaluating the efficacy and safety of immediate postoperative systemic chemotherapy in patients with suspected high-risk non-muscle-invasive bladder cancer.
Inclusion: Patients with a history and cystoscopy results indicating high-risk NMIBC:; High-grade T1; Any recurrent high-grade Ta; High-grade Ta \& Tumor diameter greater than 3 cm or multifocal; Any CIS; Any BCG failure in patients with high-grade disease; Any variant histology; Any LVI; Any high-grade prostatic urethral involvement; Patients in generally good condition with a follow-up period of 2 years.
Exclusion: Incomplete tumor resection; Concurrent upper urinary tract or prostatic urethral UC; Previous systemic chemotherapy, immunotherapy, or radiotherapy; Bladder cancer other than UC; MIBC or benign diseases; Active infection; Uncontrollable urinary tract infection; Serum creatinine greater than twice the normal level; Leukopenia/thrombocytopenia.