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

Primary Purpose

Non Muscle-invasive Bladder Cancer

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
IPOI (pre-operative)
IPOP (post-operative)
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Muscle-invasive Bladder Cancer focused on measuring low-grade, NMIBC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Bicêtre HospitalRecruiting
  • Poitiers University HospitalRecruiting
  • Rouen University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IPOI

IPOP

Arm Description

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

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

Outcomes

Primary Outcome Measures

PFS

Secondary Outcome Measures

Full Information

First Posted
February 27, 2014
Last Updated
April 4, 2017
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02075060
Brief Title
Evaluation of Immediate Preoperative Instillation (IPOI) of Mitomycin C Compared to Early Postoperative Instillation (IPOP) in Non-muscle Invasive Bladder Cancer
Acronym
IPOI vs IPOP
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
January 18, 2018 (Anticipated)
Study Completion Date
January 18, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Muscle-invasive Bladder Cancer
Keywords
low-grade, NMIBC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IPOI
Arm Type
Experimental
Arm Description
One arm with pre-operative instillation of mitomycine 1h before TURB (IPOI : Instillation pré-opératoire immédiate),
Arm Title
IPOP
Arm Type
Active Comparator
Arm Description
One arm with early post-operative instillation of mitomycine within 24 hours (IPOP : Instillation Post Opératoire Précoce).
Intervention Type
Procedure
Intervention Name(s)
IPOI (pre-operative)
Intervention Type
Procedure
Intervention Name(s)
IPOP (post-operative)
Primary Outcome Measure Information:
Title
PFS
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacques IRANI, MD, PhD
Phone
: +33 (0)5.49.44.44.77
Email
jacques.irani@chu-poitiers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques IRANI, MD, PhD
Organizational Affiliation
Poitiers University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bicêtre Hospital
City
Kremlin Bicêtre
ZIP/Postal Code
94270
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geraldine PIGNOT, MD
Phone
+33-1 45 21 36 98
Email
gg_pignot@yahoo.fr
Facility Name
Poitiers University Hospital
City
Poitiers
ZIP/Postal Code
86100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques IRANI, MD, PhD
Phone
+33 (0)5.49.44.44.77
Email
jacques.irani@chu-poitiers.fr
First Name & Middle Initial & Last Name & Degree
Jacques IRANI, MD, PhD
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

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

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