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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.

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.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-005263-27-FR
Enrollment
54
Registered
2013-06-12
Start date
2014-01-22
Completion date
Unknown
Last updated
2018-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NON-MUSCLE INVASIVE BLADDER CANCER MedDRA version: 14.1 Level: LLT Classification code 10005004 Term: Bladder cancer NOS System Organ Class: 100000004864

Interventions

Trade Name: AMETYCINE 40 MG Pharmaceutical Form: Powder for intravesical solution

Sponsors

CHU POITIERS
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: ALLERGY TO MYTOMYCIN-C Traumatic poll -TUMOR > 3 CM -ANY SIGN OF TUMOR EXTENDING TO THE BLADDER MUSCLE OR BEYOND

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary end point(s): -3-MONTH RECURRENCE RATE -1-YEAR RECURRENCE RATE -NUMBER OF PATIENTS WHO COULD NOT BENEFIT FROM AN EARLY PERI-OPERATIVE INSTILLATION -TOLERANCE EVALUATION AT ONE MONTH USING THE BLADDER CANCER INDEX (FRENCH VERSION: BCI-FR). -STRATIFIED ANALYSIS ACCORDING TO TUMOR CHARACTERISTICS (WEIGHT OF RESECTED TISSUE, NUMBER OF TUMORS, TUMOR STAGE, PRIMARY OR RECURRENT TUMOR) ;Timepoint(s) of evaluation of this end point: ONE YEAR FOLLOWING THE LAST INCLUSION—

Countries

France

Contacts

Public ContactFanny ABRIAT

CHU DE POITIERS

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026