NCT02075060

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2018

Completed
Last Updated

September 2, 2026

Status Verified

August 1, 2026

Enrollment Period

3.9 years

First QC Date

February 27, 2014

Last Update Submit

August 27, 2026

Conditions

Non Muscle-invasive Bladder Cancer

Keywords

low-gradeNMIBC

Outcome Measures

Primary Outcomes (1)

  • Time to disease recurrence

    Time to disease recurrence is defined as the time between resection and the first cystoscopy that detects a recurrence

    12 months

Study Arms (2)

IPOI

EXPERIMENTAL

One arm with pre-operative instillation of mitomycine 1h before RTUV (IPOI)

Procedure: IPOI

IPOP

ACTIVE COMPARATOR

One arm with early post-operative instillation of mitomycine within 24 hours (IPOP)

Procedure: IPOP

Interventions

IPOIPROCEDURE

It consists to an administration of Mitomycin C before the RTUV.

IPOI
IPOPPROCEDURE

It consists to an administration of Mitomycin C after the RTUV.

IPOP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Bicêtre Hospital

Le Kremlin-Bicêtre, 94270, France

Location

Poitiers University Hospital

Poitiers, 86100, France

Location

Rouen University Hospital

Rouen, 76000, France

Location

Related Publications (1)

  • Breton 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: 32891506RESULT

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrinary Bladder NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Jacques IRANI, MD, PhD

    Poitiers University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2014

First Posted

March 3, 2014

Study Start

February 17, 2014

Primary Completion

January 18, 2018

Study Completion

January 18, 2018

Last Updated

September 2, 2026

Record last verified: 2026-08

Locations

FR(3)