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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002928-24 | EudraCT Number |
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| Name | Class |
|---|---|
| Fundación para la Investigación en Urología (FIU) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treated with IMUNO BCG Moreau RJ adjuvant. | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Instillation of IMUNO BCG Moreau RJ | Biological | 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 . |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival. | The secondary objective is to assessment the disease-free survival. | 24 months |
| Assessment of the quality of life | Assessment will be measure with FACT-BL version4th |
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Inclusion Criteria:
Exclusion Criteria:
7. Impossibility of performing a second transurethral resection (ReRTU) between 4 and 8 weeks after the first.
8. Inability to start treatment within the first 4 weeks after the second transurethral resection (ReRTU).
9. Participation in another clinical study where they received a research drug in the 6 months prior to signing the informed consent.
10. Woman considered potentially fertile. Following the Clinical Trial Facilitation Group (CTFG) recommendations, a woman is considered childbearing potential (WOCBP), following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
11. Patients with difficulties to perform the follow-up visits established in the protocol.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ingrid Murillo, MSc. | Contact | 0034986330400 | ingrid.murillo@biofabri.es | |
| Sara Barja, MSc. | Contact | 0034986330400 | sara.barja@biofabri.es |
| Name | Affiliation | Role |
|---|---|---|
| Miguel Unda, MD | Hospital Universitario Basurto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complexo Hospitalario Universitario A Coruña | Not yet recruiting | A Coruña | 15006 | Spain |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 24 months |
| Assessment of adverse reactions | Assessment will be measure in number and relation with IMP | 24 months |
| Assessment of the dropout rate due to toxicity | Assessment will be measure in number | 24 months |
| Hospital Universitario Basurto | Active, not recruiting | Bilbao | 48013 | Spain |
| Complejo Hospitalario Puerta Del Mar | Active, not recruiting | Cadiz | 11009 | Spain |
| Complejo Hospitalario Regional Reina Sofía | Active, not recruiting | Córdoba | 14004 | Spain |
| Hospital Universitario Virgen de Las Nieves | Recruiting | Granada | 18014 | Spain |
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| Complejo Hospitalario Médico Quirúrjico de Jaén | Active, not recruiting | Jaén | 23007 | Spain |
| Hospital de Especialidades de Jerez de La Frontera | Active, not recruiting | Jerez de la Frontera | 11408 | Spain |
| Hospital Fundacion Jimenez Diaz | Active, not recruiting | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Active, not recruiting | Madrid | 28041 | Spain |
| Complejo Universitario La Paz | Active, not recruiting | Madrid | 28046 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Not yet recruiting | Majadahonda | 28222 | Spain |
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| Complejo Hospitalario Regional de Málaga | Not yet recruiting | Málaga | 29010 | Spain |
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| Hospital Universitario Central de Asturias | Not yet recruiting | Oviedo | 33011 | Spain |
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| Clinica Universidad de Navarra | Not yet recruiting | Pamplona | 31008 | Spain |
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| Hospital Clínico Universitario de Valladolid | Not yet recruiting | Valladolid | 47003 | Spain |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |