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

Poitiers University Hospital

Status and phase: Unknown; Phase 2

Conditions: Non Muscle-invasive Bladder Cancer

Treatments: Procedure: IPOI (pre-operative); Procedure: IPOP (post-operative)

Study type: Interventional

Funder types: Other

Identifiers

NCT02075060

IPOI vs IPOP

Details and patient eligibility

About

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 .

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

IPOI

Experimental group

Description:

One arm with pre-operative instillation of mitomycine 1h before TURB (IPOI : Instillation pré-opératoire immédiate),

Treatment:

Procedure: IPOI (pre-operative)

IPOP

Active Comparator group

Description:

One arm with early post-operative instillation of mitomycine within 24 hours (IPOP : Instillation Post Opératoire Précoce).

Treatment:

Procedure: IPOP (post-operative)