Evaluation of Immediate Preoperative Instillation (IPOI) of Mitomycin C Compared to Early Postoperative Instillation (IPOP) in Non-muscle Invasive Bladder Cancer
Conditions
Non Muscle-invasive Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
low-grade, NMIBC
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: IPOI (pre-operative) Type: Procedure
Name: IPOP (post-operative) Type: Procedure
Overall Status
Recruiting
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 .
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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,

- 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).
Locations
Bicêtre Hospital
Kremlin Bicêtre, France
Status: Recruiting
Contact: Geraldine PIGNOT, MD - +33-1 45 21 36 98 - gg_pignot@yahoo.fr
Poitiers University Hospital
Poitiers, France
Status: Recruiting
Contact: Jacques IRANI, MD, PhD - +33 (0)5.49.44.44.77 - jacques.irani@chu-poitiers.fr
Rouen University Hospital
Rouen, France
Status: Active, not recruiting
Start Date
February 2014
Sponsors
Poitiers University Hospital
Source
Poitiers University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page