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Evaluation of the effacay of the intravesical thermochemotherapy with mitomycin C in intermediate risk superficial bladder tumors recurrent after BCG. - ND

Evaluation of the effacay of the intravesical thermochemotherapy with mitomycin C in intermediate risk superficial bladder tumors recurrent after BCG. - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-003630-17-IT
Enrollment
Unknown
Registered
2008-09-26
Start date
2008-09-01
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

intermediate risk superficial bladder tumors MedDRA version: 9.1 Level: LLT Classification code 10066750 Term: Bladder transitional cell carcinoma recurrent

Interventions

Trade Name: MITOMYCIN C*INIET 1FL 40MG Pharmaceutical Form: Powder for bladder irrigation INN or Proposed INN: Mitomycin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Con

Sponsors

AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: patients with transitional cell carcinoma of the bladder, Ta or T1, G1-2, mono- or multifocal (except multifocal T1G2), recurred after at least one complete induction cycle of BCG informed consensus WHO performance status 0-2 , age less than 85 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: high risk superficial bladder tumor (T1G3, CIS, T1G2 multifocal, positive urinary citology ) or invasive bladder tumor not transitional cell bladder tumor WHO performance status 3-4, age more than 85 troubles in carrying out a follow-up because of distance or other illnesses WBC less than 3000/mm3 and/or PLT less than 100000/mm3 altered renal and hepatic function urinary infections insufficient bladder capacity no BCG treatment transitional cell carcinoma within prostatic urethra or ureters/renal pelvis pregnancy or breastfeeding metastatic desease (except for basalioma)

Design outcomes

Primary

MeasureTime frame
Main Objective: evaluation of the prophylactic activity of thermochemotherapy with mitomycin C obtained with the Pelvix TT system in papillary superficial intermediate risk bladder tumors recurrent after BCG global tolerability of such treatment;Secondary Objective: - healing of the desease -evaluation of the quality of life before and after treatment;Primary end point(s): 1) absence of an adverse event within 12 months, defined as: recurrence of superficial desease number of recurrences progression of desease death for any cause We will consider as response the absence of an adverse event within 12 months. 2)recording and grading of side effects—

Countries

Italy

Outcome results

None listed

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