Combination therapy in bladder cancer

Phase 1

• Conditions: patients with High grade Non-Muscle Invasive Bladder Cancer with high progression risk; MedDRA version: 20.0Level: HLGTClassification code 10038364Term: Renal and urinary tract neoplasms malignant and unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-004540-37-IT
• Lead Sponsor: AZIENDA OSPEDALIERA SANT'ANDREA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-06
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 140

Inclusion Criteria

-patients with High grade Non-Muscle Invasive Bladder Cancer
- high progression risk ((EORTC risk score >6)
- males
- Age > 40 years old and < 75 years old
-signed written informed consent form
- capacity for discernment
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 66
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 66

Exclusion Criteria

oLow Risk Non-Muscle Invasive Bladder Cancer
oMuscle Invasive Bladder Cancer
oConcomitant Urothelial Bladder Cancer in the Upper-Urinary Tract
oPrevious bladder or prostate surgery
oProstate or bladder radiotherapy
oUrinary tract infection
oChronic urinary retention or indwelling catheters
oNeurological patients
oPrevious BCG infections
oPrevious or current chemotherapy for other kind of cancers
oPatients older than 75
oWHO performance status 3-4
oResidual tumour on re-TURB

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to evaluate the effect in term of recurrence rate of sequential combination therapy of Mitomycin and Bacillus Calmette-Guérin versus Bacillus Calmette-Guérin monotherapy in patients with High grade Non-Muscle Invasive Bladder Cancer;Secondary Objective: to evaluate the overall toxicity of sequential combination therapy of Mitomycin and Bacillus Calmette-Guérin versus Bacillus Calmette-Guérin monotherapy;Primary end point(s): recurrence rate;Timepoint(s) of evaluation of this end point: from 3 to 24 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): toxicity;Timepoint(s) of evaluation of this end point: from 3 to 24 months