Evaluation of Immediate Preoperative Instillation (IPOI) of Mitomycin C Compared to Early Postoperative Instillation (IPOP) in Non-muscle Invasive Bladder Cancer

Poitiers University Hospital3 sites in 1 country54 target enrollmentFebruary 2014

ConditionsNon Muscle-invasive Bladder Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Non Muscle-invasive Bladder Cancer
Sponsor: Poitiers University Hospital
Enrollment: 54
Locations: 3
Primary Endpoint: PFS
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this pilot study is to assess the efficacy and toxicity of immediate pre-operative instillation of mitomycin C compared to the standard early post-operative .

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

January 18, 2018

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Poitiers University Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age \> 18 years,
•Primary or recurrent bladder tumor with endoscopic papillary aspect,
•One or two bladder tumors,
•Cytology before TURB showing no high-grade cells,
•Patients without tutorship or subordination (ou curatorship),
•Patients under the general social security system or qualifying through a third party,
•Informed consent signed by the patient after clear and fair information.

Exclusion Criteria

•Age \< 18 years,
•Allergy to mitomycin C,
•Traumatic stenting,
•Upper tract urothelial cancer,
•Urethral invasion,
•History of muscle invasive bladder cancer,
•Extensive tumor (3 cm or more),
•Any contraindication to TURB,
•Simultaneous participation in another clinical research study,
•Patients not insured by the social security or not qualifying through a third party,