Clinical trial · Interventional
Evaluation of Immediate Preoperative Instillation (IPOI) of Mitomycin C Compared to Early Postoperative Instillation (IPOP) in Non-muscle Invasive Bladder Cancer
Evaluation of Mitomycin C in Immediate Pre-operative Instillation (IPOI) of Endoscopic Resections of Bladder Tumors Compared to Early Post-operative Instillation (IPOP) : Multicentric, Randomized Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study seeks to optimize the management of TVNIM (reduction of the risk of reccurence of the disease) by comparing in terms of efficacy and tolerance the immediate preoperative administration of mitomycin C (IPOI) to an early postoperative administration (IPOP). It's a national, multicenter, prospective, randomized, comparative study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Muscle-invasive Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IPOI | Procedure | — | UNRESOLVED |
| IPOP | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IPOI
- description
- One arm with pre-operative instillation of mitomycine 1h before RTUV (IPOI)
- interventionNames
- Procedure: IPOI
- type
- ACTIVE_COMPARATOR
- label
- IPOP
- description
- One arm with early post-operative instillation of mitomycine within 24 hours (IPOP)
- interventionNames
- Procedure: IPOP
Primary outcomes (1)
- measure
- Time to disease recurrence
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years, * Primary or recurrent bladder tumor with endoscopic papillary aspect, * One or two bladder tumors, * Cytology before RTUV 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 RTUV, * 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).
References
Publications (1)
- RESULTBreton J, Bernardeau S, Vallee M, Pillot P, Lebacle C, Delpech PO, Charles T, Biscans C, Vallat A, Pfister C, Irani J. [Single, immediate postoperative intra-vesical instillation (SI) compared to a single preoperative intra-vesical instillation of mitomycin C in non-muscle invasive bladder cancer (NMIBC). Phase II randomized trial]. Prog Urol. 2021 Feb;31(2):63-70. doi: 10.1016/j.purol.2020.07.245. Epub 2020 Sep 3. French. PMID 32891506