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

Phase 2

• Conditions: Non Muscle-invasive Bladder Cancer
• Interventions: Procedure: IPOI (pre-operative); Procedure: IPOP (post-operative)

• Registration Number: NCT02075060
• Lead Sponsor: Poitiers University Hospital

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-27
• Study First Submitted QC: 2014-02-28
• Study First Posted: 2014-03-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-06
• Primary Completion: 2018-01-18
• Study Completion: 2018-01-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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,
• Patients with enhanced protection, namely pregnant or lactating women, persons deprived of their liberty by a judicial or administrative decision, people staying in a health or social institution, adults under legal protection, and finally patients in emergency situations,
• Pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study (i.e. hormonal / mechanical contraceptive : oral, injectable, transdermal, implantable, intrauterine or surgical device: tubal ligation, hysterectomy, total oophorectomy).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IPOI	IPOI (pre-operative)	One arm with pre-operative instillation of mitomycine 1h before TURB (IPOI : Instillation pré-opératoire immédiate),
IPOP	IPOP (post-operative)	One arm with early post-operative instillation of mitomycine within 24 hours (IPOP : Instillation Post Opératoire Précoce).

Primary Outcome Measures

Name	Time	Method
PFS	12 months

Trial Locations

Locations (3)

Rouen University Hospital; 🇫🇷 Rouen, France

Poitiers University Hospital; 🇫🇷 Poitiers, France

Bicêtre Hospital; 🇫🇷 Kremlin Bicêtre, France