Evaluation of Immediate Preoperative Instillation (IPOI) of Mitomycin C Compared to Early Postoperative Instillation (IPOP) in Non-muscle Invasive Bladder Cancer
NCT ID: NCT02075060
Last Updated: 2017-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
54 participants
INTERVENTIONAL
2014-02-28
2018-01-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IPOI
One arm with pre-operative instillation of mitomycine 1h before TURB (IPOI : Instillation pré-opératoire immédiate),
IPOI (pre-operative)
IPOP
One arm with early post-operative instillation of mitomycine within 24 hours (IPOP : Instillation Post Opératoire Précoce).
IPOP (post-operative)
Interventions
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IPOI (pre-operative)
IPOP (post-operative)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Poitiers University Hospital
OTHER
Responsible Party
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Principal Investigators
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Jacques IRANI, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Poitiers University Hospital
Locations
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Bicêtre Hospital
Le Kremlin-Bicêtre, , France
Poitiers University Hospital
Poitiers, , France
Rouen University Hospital
Rouen, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IPOI vs IPOP
Identifier Type: -
Identifier Source: org_study_id
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