High-risk Non-muscle Invasive Bladder Cancer
Conditions
Brief summary
The effectiveness of the IMUNO BCG Moreau RJ strain will be assessed primarily by calculating the rate of progression at 24 months after the last transurethral resection (LTRU). The progression rate at 24 months is the proportion of patients who, after the last tumor resection and within a follow-up period of 24 months, undergo progression according to the TNM classification approved by the International Union Against Cancer in its 8th edition of 2017.
Detailed description
Progression rate at 12 months: proportion of patients, out of the total, who have been on treatment with the IMUNO BCG Moreau RJ strain and in whom the tumour has progressed within a 12-month follow-up period., Progression rate at 24 months: proportion of patients, out of the total, who have been on treatment with the IMUNO BCG Moreau RJ strain and in whom the tumour has progressed within a follow-up period of 24 months., Disease-free survival: tumour classification (TNM) from the date of first instillation (time zero) to recurrence or end of follow-up will be assessed., Quality of life: questionnaire published and validated in the scientific literature and adapted to Spanish, Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-BL) v. 4., Adverse reactions (ARs): the description of ARs will be based on the MedDRA dictionary of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The number and frequency of patients with AEs, their severity, as well as the distribution of all AEs will be described., Dropout rate due to toxicity: study withdrawals (number and percentage) due to the impossibility of continuing due to side effects will be evaluated, as well as those patients who have not discontinued., Immunological response: analysis of cytokines in urine prior to instillation at induction visits 1, 2, 5 and 6.
Interventions
DRUGIMUNO BCG Moreau RJ
Sponsors
Biofabri S.L., Fundacion Para La Investigacion En Urologia
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effectiveness of the IMUNO BCG Moreau RJ strain will be assessed primarily by calculating the rate of progression at 24 months after the last transurethral resection (LTRU). The progression rate at 24 months is the proportion of patients who, after the last tumor resection and within a follow-up period of 24 months, undergo progression according to the TNM classification approved by the International Union Against Cancer in its 8th edition of 2017. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression rate at 12 months: proportion of patients, out of the total, who have been on treatment with the IMUNO BCG Moreau RJ strain and in whom the tumour has progressed within a 12-month follow-up period., Progression rate at 24 months: proportion of patients, out of the total, who have been on treatment with the IMUNO BCG Moreau RJ strain and in whom the tumour has progressed within a follow-up period of 24 months., Disease-free survival: tumour classification (TNM) from the date of first instillation (time zero) to recurrence or end of follow-up will be assessed., Quality of life: questionnaire published and validated in the scientific literature and adapted to Spanish, Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-BL) v. 4., Adverse reactions (ARs): the description of ARs will be based on the MedDRA dictionary of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The number and frequenc | — |
Countries
Spain
Outcome results
None listed