Clinical trial to evaluate recurrence in bladder cancer using two differents strategies of treatment: chemohyperthermia (QH) with mitomycin-C prior to transurethral resection of bladder in ambulatory surgery program or post resection treatment with mitomycin C in normothermia
- Conditions
- MedDRA version: 18.1Level: SOCClassification code 10038359Term: Renal and urinary disordersSystem Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 18.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2015-005151-27-ES
- Lead Sponsor
- Hospital Universitario de Canarias
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
More than 18 years
vesical tumor <3cm
multiple vesical tumors, in total <8 cm and <3cm each one
ASA less or equal than III
low or intermediate risk
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 83
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
- Known hipersensibility to MMC or excipients.
- Pregnant or lactancy
- Recent Transuretral resection (<2 years)
- Vesical in situ carcinoma suspected (Cis).
- Vesical tumor > 3 cm
- to have more than 8 tumors
- Severe cardiopathy
- Chronic renal insufficinecy
- Trombocitopenia ( <100.000 platets) ,coagulation disorders and bleeding tendency for other causes.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method