EVALUATION OF EARLY PRE-OPERATIVE INTRAVESICAL INSTILLATION OF MYTOMYCIN-C AFTER TRANSURETHRAL RESECTION OF BLADDER TUMOR COMPARED TO EARLY POST-OPERATIVE INSTILLATION. A RANDOMIZED MULTICENTER STUDY.
Phase 1
- Conditions
- ON-MUSCLE INVASIVE BLADDER CANCERMedDRA version: 14.1Level: LLTClassification code 10005004Term: Bladder cancer NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-005263-27-FR
- Lead Sponsor
- CHU POITIERS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
ALL PATIENTS FOR WHOM STANDARD EARLY POST-OPERATIVE INTRAVESICAL INSTILLATION OF MYTOMYCIN-C IS INDICATED, i.e.:
- PRIMARY OR RECURRENT PAPILLARY BLADDER TUMOR OF 3 CM OR LESS WITH NO ARGUMENT IN FAVOR OF A MUSCLE INVASIVE TUMOR
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14
Exclusion Criteria
ALLERGY TO MYTOMYCIN-C
Traumatic poll
-TUMOR > 3 CM
-ANY SIGN OF TUMOR EXTENDING TO THE BLADDER MUSCLE OR BEYOND
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: REDUCTION IN BLADDER CANCER RECURRENCE;Secondary Objective: FEASABILITY AND TOLERANCE OF PRE-OPERATIVE INTRAVESICAL INSTILLATION OF MYTOMYCIN-C;Primary end point(s): RECURRENCE-FREE SURVIVAL;Timepoint(s) of evaluation of this end point: ONE YEAR AFTER TRANSURETHRAL RESECTION OF BLADDER TUMOR AND EARLY PERI-OPERATIVE INSTILLATION OF MYTOMYCIN-C
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -3-MONTH RECURRENCE RATE<br>-1-YEAR RECURRENCE RATE<br>-NUMBER OF PATIENTS WHO COULD NOT BENEFIT FROM AN EARLY PERI-OPERATIVE INSTILLATION<br>-TOLERANCE EVALUATION AT ONE MONTH USING THE BLADDER CANCER INDEX (FRENCH VERSION: BCI-FR).<br>-STRATIFIED ANALYSIS ACCORDING TO TUMOR CHARACTERISTICS (WEIGHT OF RESECTED TISSUE, NUMBER OF TUMORS, TUMOR STAGE, PRIMARY OR RECURRENT TUMOR) <br>;Timepoint(s) of evaluation of this end point: ONE YEAR FOLLOWING THE LAST INCLUSIO