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Trial Title:
Evaluation of Immediate Preoperative Instillation (IPOI) of Mitomycin C Compared to Early Postoperative Instillation (IPOP) in Non-muscle Invasive Bladder Cancer
NCT ID:
NCT02075060
Condition:
Non Muscle-invasive Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Conditions: Keywords:
low-grade
NMIBC
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
IPOI (pre-operative)
Arm group label:
IPOI
Intervention type:
Procedure
Intervention name:
IPOP (post-operative)
Arm group label:
IPOP
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 .
Criteria for 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Bicêtre Hospital
Address:
City:
Kremlin Bicêtre
Zip:
94270
Country:
France
Status:
Recruiting
Contact:
Last name:
Geraldine PIGNOT, MD
Phone:
+33-1 45 21 36 98
Email:
gg_pignot@yahoo.fr
Facility:
Name:
Poitiers University Hospital
Address:
City:
Poitiers
Zip:
86100
Country:
France
Status:
Recruiting
Contact:
Last name:
Jacques IRANI, MD, PhD
Phone:
+33 (0)5.49.44.44.77
Email:
jacques.irani@chu-poitiers.fr
Investigator:
Last name:
Jacques IRANI, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Rouen University Hospital
Address:
City:
Rouen
Zip:
76000
Country:
France
Status:
Active, not recruiting
Start date:
February 2014
Completion date:
January 18, 2018
Lead sponsor:
Agency:
Poitiers University Hospital
Agency class:
Other
Source:
Poitiers University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02075060
