European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (Ta, T1, and Carcinoma in Situ).
Marko Babjuk, Maximilian Burger, Otakar Capoun...
https://pubmed.ncbi.nlm.nih.gov/34511303Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06889623
Impact of Immediate Cisplatin/Gemcitabine Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer: an Open-label, Single-arm, Prospective Trial
Led by Changhai Hospital · Updated on 2025-03-21
72
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of giving systemic chemotherapy immediately after surgery in patients with suspected high-risk non-muscle-invasive bladder cancer (NMIBC). This type of bladder cancer often recurs, and residual tumors or floating tumor cells after standard surgery may increase this risk. The study aims to see if chemotherapy given within 24 hours after tumor removal can reduce recurrence and improve patient outcomes. Participants will receive chemotherapy with cisplatin and gemcitabine through an intravenous infusion within 24 hours after their transurethral resection of bladder tumor (TURBT) surgery. Fluid samples will be collected before and after surgery and chemotherapy to assess tumor changes. Following this, patients will undergo one year of intravesical Bacillus Calmette-Guérin (BCG) treatment according to guidelines, with regular imaging and cystoscopic exams to monitor their condition. Throughout the study, researchers will monitor recurrence-free survival over one year, pathological changes 2-6 weeks after chemotherapy, and any serious side effects. They will also evaluate chromosomal instability using UroCAD testing around 15 days post-surgery. Participants will be closely followed with imaging and bladder examinations, with the total follow-up period lasting approximately two years to assess long-term effects and safety.
CONDITIONS
Brief Title
Immediate Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with a history and cystoscopy results indicating high-risk NMIBC, including high-grade T1, any recurrent high-grade Ta, high-grade Ta with tumor diameter greater than 3 cm or multifocal, any CIS, any BCG failure in patients with high-grade disease, any variant histology, any LVI, or any high-grade prostatic urethral involvement
- Patients in generally good condition with a follow-up period of 2 years
- Age 18 years or older
You will not qualify if you...
- Bladder cancer other than urothelial carcinoma
- Muscle-invasive bladder cancer or benign diseases
- Incomplete tumor resection
- Active infection
- Concurrent upper urinary tract or prostatic urethral urothelial carcinoma
- Previous systemic chemotherapy, immunotherapy, or radiotherapy
- Leukopenia or thrombocytopenia
- Serum creatinine greater than twice the normal level
- Uncontrollable urinary tract infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Within 24 hours after surgery
Participants receive systemic chemotherapy with cisplatin and gemcitabine via intravenous infusion within 24 hours after transurethral resection of bladder tumor (TURBT).
1 visit (in-person)
Treatment
Duration - 1 year
Following the immediate chemotherapy, participants undergo 1 year of intravesical Bacillus Calmette-Guérin (BCG) induction and maintenance therapy with regular imaging studies and cystoscopic examinations to assess pathological response.
Regular visits for imaging and cystoscopy during therapy
Follow-up
Duration - About 2 years
Participants are followed for up to 2 years after the first chemotherapy to monitor recurrence-free survival and adverse events.
Periodic follow-up visits for assessments
Trial Site Locations
Total: 1 location
1
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
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Research Team
S
Shuxiong Zeng, M.D. Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Long-term Outcomes from a Phase 2 Study of Neoadjuvant Chemotherapy for Muscle-invasive Bladder Cancer (SWOG S1314; NCT02177695).
Thomas W Flaig, Catherine M Tangen, Siamak Daneshmand...
https://pubmed.ncbi.nlm.nih.gov/37414705Value of an Immediate Intravesical Instillation of Mitomycin C in Patients with Non-muscle-invasive Bladder Cancer: A Prospective Multicentre Randomised Study in 2243 patients.
Judith Bosschieter, Jakko A Nieuwenhuijzen, Tessa van Ginkel...
https://pubmed.ncbi.nlm.nih.gov/28705539Perioperative dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin in muscle-invasive bladder cancer (VESPER): survival endpoints at 5 years in an open-label, randomised, phase 3 study.
Christian Pfister, Gwenaelle Gravis, Aude Flechon...
https://pubmed.ncbi.nlm.nih.gov/38142702Effect of Intravesical Instillation of Gemcitabine vs Saline Immediately Following Resection of Suspected Low-Grade Non-Muscle-Invasive Bladder Cancer on Tumor Recurrence: SWOG S0337 Randomized Clinical Trial.
Edward M Messing, Catherine M Tangen, Seth P Lerner...
https://pubmed.ncbi.nlm.nih.gov/29801011