Immediate Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer
Impact of Immediate Cisplatin/Gemcitabine Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer: an Open-label, Single-arm, Prospective Trial
Changhai Hospital
72 participants
Jun 1, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria10
- 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 Criteria9
- Bladder cancer other than UC
- MIBC or benign diseases
- Incomplete tumor resection
- Active infection
- Concurrent upper urinary tract or prostatic urethral UC
- Previous systemic chemotherapy, immunotherapy, or radiotherapy
- Leukopenia/thrombocytopenia
- Serum creatinine greater than twice the normal level
- Uncontrollable urinary tract infection
Interventions
Systemic chemotherapy with cisplatin/gemcitabine intravenous infusion within 24 hours after TURBT
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06889623