NMIBT
Conditions
Sponsors
DR. ALEJANDRO SOUSA ESCANDÓN
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with NMIBC for which TURB is indicated except those recurrent with previous T1G3 or CIS in the last 12 moths and positive cytology - WHO scale 0, 1, 2, 3 - Age ? 18 yrs - Normal kidneys and ureters - Pre-treatment haematology and biochemistry values within acceptable limits - Negative pregnancy test for women of child-bearing potential - Written informed consent (IC) 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 34 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
Exclusion criteria: - Patient with solid tumor and muscle infiltrating aspect or with associated plane lesions suspicious for CIS - Recurrent patients with previous T1G3 or CIS in the last 12 months and positive cytology - Patients with hypersensitivity or allergy to MMC - History of limited vesical capacity (<200cc) - UCC involving the prostatic urethra or upper urinary tract - Pregnant or lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception - Other malignancy within the past five years, except: nonmelanomatous skin cancer cured by excision, adequately treated carcinoma in situ of the cervix or DCIS/LCIS of the breast or prostate cancer. cancer. - Patients with tumours histologically different tan transitional cell carcinoma - Patients that for any reason should receive concurrent chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: COMPARE EFFICACY OF NEOADJUNCTIVE THERAPY WITH CHEMO-HYPERTHERMIA WITH STANDARD ADJUNCTIVE THERAPY FOR NMIBT AT 24 MONTHS;Secondary Objective: EVALUATE EFFICACY OF NEOADJUNCTIVE THERAPY IN TERMS OF COMPLETE AND PARTIAL RESPONSE AND COMPARE TOLERABILITY, QOL AND COST EFFECTIVENESS OF BOTH TREATMENT REGIMES;Primary end point(s): DFSR (Disease Free Survival Rate);Timepoint(s) of evaluation of this end point: Cytoscopy at week 4 and at 4, 8, 12, 18 and 24 months after treatment completion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Complete and partial response of neoadjunctive therapy, tolerability, quality of life and cost effectiveness;Timepoint(s) of evaluation of this end point: Cytology at week 4, side effects reported by patient and healthcare professional before and after every instillation, qol questionnaire at screening visit and last visit. | — |
Countries
Spain
Contacts
Public ContactDR. ALEJANDRO SOUSA ESCANDÓN
HOSPITAL COMARCAL DE MONFORTE
Outcome results
None listed