bladder cancer non muscle invasive in high risk patients MedDRA version: 20.0 Level: LLT Classification code 10029759 Term: Normal delivery System Organ Class: 100000004868
Conditions
Interventions
Trade Name: MITOMICINA C
Product Name: MITOMICINA C
Pharmaceutical Form:
INN or Proposed INN: MITOMYCIN
CAS Number: 50-07-7
Sponsors
PRESURGY, S.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients older than 18 years and life expectancy = 5 years. - Patients able to give informed consent for the study. - Patients with primary non-muscle infiltrating urothelial non-muscle metamorphosed (NMIBC), uni- or multi-focal, stages Ta and T1, High Grade (2004 WHO), including old G2 High Grade and all G3. - Patients treated with optically complete TUR of the tumor and, when indicated by clinical guidelines, RE-RTU that must be performed within the first 6 weeks. - Negative bladder random biopsies for Tcis - Presence of own muscle in the TUR and / or in the RE-RTU. - RE-RTU in all cases of T1 and also in Ta tumors when the initial TUR is incomplete or with absence of muscle in the sample. 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
Exclusion criteria: Patients unable to give informed consent for their participation in the study. - Patients with a history of allergic reactions to BCG or MMC. - Patients with pacemakers or DICs. - Previous history of bladder tumors. - Antecedents of pelvic radiotherapy (bladder, prostate, rectum, vagina, uterus). - Absence of own muscle in the sample (neither in RTU nor in RE-RTU). - Patients with stage T1 who have not received RE-RTU. - Patients with Tcis isolated or associated with papillary tumor. - Presence of squamous cell carcinoma of the bladder or bladder adenocarcinoma. - Stage tumors =T2. - cN + and / or cM + tumors. - Pregnant women. Relative contraindications for the use of the EMDA system - Urethral stricture. - Giant prostatic lobe with bladder neck occlusion. - Psychosis - Alcoholism - Active untreated urinary infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the efficacy of the adjuvant with EMDA-MMC (induction x6 weekly instillations and 1 year of maintenance) compared with the BCG standard (induction x6 weekly instillations and 1 year of maintenance) in the adjuvant treatment of High Grade NMLCC. - To evaluate the efficacy of the urinary bio-marker LCM5 ADXBLADDER® in the detection of tumor recurrence, compared with urinary cytology + cystoscopy, during the follow-up of high-grade NMIBC treated with BCG or with adjuvant EMDA-MMC. ; Secondary Objective: - To assess the tolerance to adjuvant endovesical chemotherapy with EMDA-MMC compared to the BCG standard (induction x6 weekly instillations and 1 year of maintenance) in the adjuvant treatment of high-grade NMIBC. - To assess the impact on quality of life of adjuvant endovesical chemotherapy with EMDA-MMC compared to the BCG standard (induction x6 weekly instillations and 1 year of maintenance) in the adjuvant treatment of high-grade NMIBC. - Carry out a cost-effectiveness analysis of the routine implementation of the urinal biomarker MCM5 ADXBLADDER® compared to the standard follow-up with Urinary cytology + Cystoscopy in the High Grade CVNMI. ; Primary end point(s): - Disease free survival (SLE). - Detection rate (TD) of tumor recurrence with the MCM5 ADX BLADDER® bio-marker, compared with that obtained with standard cytology. ;Timepoint(s) of evaluation of this end point: Patients will undergo oncological follow-up and Quality of Life, with periodic visits, every 3 months during the first year (month 3, 6, 9 and 12) and every 6 months thereafter and until the end of the follow-up period of 5 years (month 18, 24, 30, 36, 42, 48, ... .60). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Tumor recurrence rate. - Free survival of tumor progression (SLP). - Rate of tumor progression. - Rate of completion of adjuvant treatment. - Sensitivity, Specificity, VPN and VPP of the ADXBLAADER® bio-marker. - Cost-efficiency evaluation of the use of the model developed for the follow-up of patients with high-grade NMIBP treated with adjuvant BCG or EMDA-MMC. - Impact of adjuvant treatment on patient's quality of life (FACT-BL) - Adverse effects, EA and EAS. ;Timepoint(s) of evaluation of this end point: Patients will undergo oncological follow-up and Quality of Life, with periodic visits, every 3 months during the first year (month 3, 6, 9 and 12) and every 6 months thereafter and until the end of the follow-up period of 5 years (month 18, 24, 30, 36, 42, 48, ... .60). | — |
Countries
Spain
Contacts
Public ContactCAROLINA ALOS
PRESURGY, S.L
Outcome results
None listed