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

• Conditions: intermediate risk superficial bladder tumors; MedDRA version: 9.1Level: LLTClassification code 10066750Term: Bladder transitional cell carcinoma recurrent

• Registration Number: EUCTR2008-003630-17-IT
• Lead Sponsor: AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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)

Study & Design

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