Comparison between intravesical instillation therapy with bacillus Calmette-Guérin and device assisted intravesical Mitomyscin C in patients with high risk non-muscle-invasive bladder carcinoma

Phase 1

• Conditions: on-muscle invasive bladder cancer; MedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-000150-22-FI
• Lead Sponsor: Turku University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-31
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1.Histologically proven non-muscle-invasive tumour types confined to the urinary bladder
a.Carcinoma in situ with or without a papillary tumour
b.Ta tumours of high-grade
c.any T1 tumours
2.Written informed consent is required from every eligible patient
3.Second-look TUR performed in case of T1 tumour
4.Adequate physical and mental condition to participate in the study, judged by responsible physician
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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

1.Urothelial cancer involving the prostatic urethra or upper urinary tract
2.Non-urothelial bladder cancer.
3.Age < 18 years
4.Pregnancy or lactating patient
5.Urethral stricture, stone disease, chronic urinary tract infection or any other urological condition that may comprise study participation (as judged by treating physician)
6.Prior BCG instillations
7.Prior or concurrent immunotherapy
8.Illness impairing the function of the immune system
9.Known allergy to MMC or BCG
10.Other untreated or unstable malignancy or malignancy in risk of recurrence/progression judged by treating physician
11.Expected poor compliance
12.Expected survival time less than one year
13.Ta low grade tumours
14.Muscle invasive (pT=2) tumors

Study & Design

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