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

Non Muscle-invasive Bladder Cancer Clinical Trial

— IPOI vs IPOP  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02075060
• Other study ID #: IPOI vs IPOP
• Status: Recruiting
• Phase: Phase 2
• First received: February 27, 2014
• Last updated: April 4, 2017
• Start date: February 2014
• Est. completion date: January 18, 2018

Study information

• Verified date: April 2017
• Source: Poitiers University Hospital
• Contact: Jacques IRANI, MD, PhD
• Phone: : +33 (0)5.49.44.44.77
• Email: jacques.irani[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: January 18, 2018
• Est. primary completion date: January 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Non Muscle-invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Procedure:
• IPOI (pre-operative)

• IPOP (post-operative)

Locations

Country	Name	City	State
France	Bicêtre Hospital	Kremlin Bicêtre
France	Poitiers University Hospital	Poitiers
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS		12 months