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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
Conditions
Non Muscle-invasive Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
low-grade, NMIBC
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: IPOI (pre-operative)
Type: Procedure
Name: IPOP (post-operative)
Type: Procedure
Overall Status
Recruiting
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
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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).
- 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).
Locations
Bicêtre Hospital
Kremlin Bicêtre, France
Poitiers University Hospital
Status: Recruiting
Contact: Geraldine PIGNOT, MD - +33-1 45 21 36 98 - gg_pignot@yahoo.fr
Poitiers, France
Rouen University Hospital
Status: Recruiting
Contact: Jacques IRANI, MD, PhD - +33 (0)5.49.44.44.77 - jacques.irani@chu-poitiers.fr
Rouen, France
Status: Active, not recruiting
Start Date
February 2014
Sponsors
Poitiers University Hospital
Source
Poitiers University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page