Non Muscle-invasive Bladder Cancer
Conditions
Keywords
low-grade, NMIBC
Brief summary
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.
Detailed description
Methods. We performed a multicenter randomized trial between February 17, 2014 and November 24, 2016 (registration number 2012-004341-32). Sixty patients with two or less, primary or recurrent papillary bladder tumors and a negative urinary cytology were planned. Cystoscopy was performed at 3, 6 and 12 months after TURB. Our primary endpoint was disease-free interval. Secondary endpoints were recurrence rate at 3 and 12 months, rate of patients in whom instillation could not be performed and tolerance 1 month after TURB using BCI-Fr score
Interventions
PROCEDUREIPOI
It consists to an administration of Mitomycin C before the RTUV.
PROCEDUREIPOP
It consists to an administration of Mitomycin C after the RTUV.
Sponsors
Poitiers University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to disease recurrence | 12 months | Time to disease recurrence is defined as the time between resection and the first cystoscopy that detects a recurrence |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORJacques IRANI, MD, PhD
Poitiers University Hospital
Outcome results
None listed