Bladder cancer is the fourth reason of neoplasia in our environment, there are 25 new cases diagnosed per 100,000 inhabitants each year. To decrease the recurrence there are two standardized treatments: Mitomycin as chemotherapy drug and BCG \*Bacile Calmette-Guérin" as immunotherapy drug. BCG Moreau strain is not authorized by AEMPS, it was developed in Brazil and this country has extensive experience in treatment of non-muscle invasive bladder cancer with BCG Moreau, also BCG Moreau Rio de Janeiro make same immunological reaction as TICE, but with less adverse events. Thus, BCG Moreau RJ treatment could be used more time than TICE with the same dose, keeping immunologic status and better prophylaxis of recurrence or progression results for the patient. Each patient will be instillated via transurethral each time with 80 mg of IMUNO BCG Moreau RJ. There are 15 instillations during the clinical trial, 6 instillations on induction phase and 9 will be performed during maintaince phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
306
Instillation in bladder will be done once per week during first six weeks after inclusion, and 3 instillations (one per week) on month three, another three on moth six and last three on month twelve .
Complexo Hospitalario Universitario A Coruña
A Coruña, Spain
NOT_YET_RECRUITINGHospital Universitario Basurto
Bilbao, Spain
ACTIVE_NOT_RECRUITINGComplejo Hospitalario Puerta Del Mar
Cadiz, Spain
ACTIVE_NOT_RECRUITINGComplejo Hospitalario Regional Reina Sofía
Córdoba, Spain
ACTIVE_NOT_RECRUITINGHospital Universitario Virgen de Las Nieves
Granada, Spain
RECRUITINGComplejo Hospitalario Médico Quirúrjico de Jaén
Jaén, Spain
ACTIVE_NOT_RECRUITINGHospital de Especialidades de Jerez de La Frontera
Jerez de la Frontera, Spain
ACTIVE_NOT_RECRUITINGHospital Fundacion Jimenez Diaz
Madrid, Spain
ACTIVE_NOT_RECRUITINGHospital Universitario 12 de Octubre
Madrid, Spain
ACTIVE_NOT_RECRUITINGComplejo Universitario La Paz
Madrid, Spain
ACTIVE_NOT_RECRUITING...and 5 more locations
progression-free survival
The primary objective is to assessment the progression-free survival of patients diagnosed with high-risk non-muscle invasive bladder tumors treated with IMUNO BCG Moreau RJ adjuvant.
Time frame: 24 months
Disease-free survival.
The secondary objective is to assessment the disease-free survival.
Time frame: 24 months
Assessment of the quality of life
Assessment will be measure with FACT-BL version4th
Time frame: 24 months
Assessment of adverse reactions
Assessment will be measure in number and relation with IMP
Time frame: 24 months
Assessment of the dropout rate due to toxicity
Assessment will be measure in number
Time frame: 24 months
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