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

• Register: EUCTR
• Last refreshed on: 11 June 2018
• Main ID: EUCTR2018-000150-22-FI
• Date of registration: 31/05/2018
• Prospective Registration: Yes
• Primary sponsor: Turku University Hospital
• Public title: 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
• Scientific title: Intravesical instillation therapy with bacillus Calmette-Guérin (BCG) and sequential BCG and electromotive Mitomycin-C (EMDA-MCC) in patients with high risk non-muscle-invasive bladder carcinoma - FB10
• Date of first enrolment: 05/06/2018
• Target sample size: 300
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-000150-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Finland

Contacts

• Name: Turku University Hospital
• Affiliation: Turku University Hospital

• Name: Turku University Hospital
• Affiliation: Turku University Hospital

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Non-muscle invasive bladder cancer
MedDRA version: 20.0 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Pharmaceutical Form: Intravesical solution
Other descriptive name: BCG (BACILLUS CALMETTE-GUÉRIN), LIVE ATTENUATED, STRAIN RIVM (STRAIN 1173-P2 DERIVED)
Other descriptive name: BACILLUS CALMETTE-GUÉRIN (BCG), TICE

Pharmaceutical Form: Intravesical solution
INN or Proposed INN: MITOMYCIN
CAS Number: 50-07-7

Primary Outcome(s)

Primary end point(s): Recurrence

Secondary Objective: 1. To evaluate if sequential BCG/EMDA-MMC is superior to BCG monotherapy in preventing progression, disease specific and overall mortality
2. To evaluate side-effect profiles, tolerability and adverse effects of the different treatment options

Main Objective: 1. To evaluate if sequential BCG/EMDA-MMC is superior to BCG monotherapy in preventing recurrences

Timepoint(s) of evaluation of this end point: two years after randomisation

Secondary Outcome(s)

Secondary end point(s): Progression
Bladder cancer spesific mortality

Timepoint(s) of evaluation of this end point: two years after randomisation (progression)
five years and ten years (mortality)

Secondary ID(s)

T14/2018

Source(s) of Monetary Support

Grants