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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
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

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
Primary Outcome Measures
NameTimeMethod
PFS12 months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (3)

Bicêtre Hospital

🇫🇷

Kremlin Bicêtre, France

Poitiers University Hospital

🇫🇷

Poitiers, France

Rouen University Hospital

🇫🇷

Rouen, France

Bicêtre Hospital
🇫🇷Kremlin Bicêtre, France
Geraldine PIGNOT, MD
Contact
+33-1 45 21 36 98
gg_pignot@yahoo.fr

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