E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-muscle-invasive urothelial carcinoma |
Carcinoma urotelial no músculo invasivo |
|
E.1.1.1 | Medical condition in easily understood language |
Urothelial carcinoma |
Carcinoma urotelial |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluation of the NMIUC early recurrence rate comparing intravesical instillation of neoadjuvant chemotherapy with RTUV with conventional TURR without neoadjuvant chemotherapy. |
Evaluación de la tasa de recurrencias tempranas del CVNMI comparando la instilación intravesical de quimioterapia neoadyuvante a RTUV con la RTUV convencional sin quimioterapia neoadyuvante. |
|
E.2.2 | Secondary objectives of the trial |
1. Assessment of toxicity, adverse events and complications attributable to intravesical instillation of pre-RTUV chemotherapy. 2. To determine the rate of late recurrences (between 12 and 60 months after the intervention) in both groups. 3. Compare the free time of recurrences between both groups. 4. Determine clinical and demographic variables that could influence a better clinical response. |
1. Evaluación de la toxicidad, eventos adversos y complicaciones atribuibles a la instilación intravesical de quimioterapia previa a la RTUV. 2. Determinar tasa de recurrencias tardías (entre 12 y 60 meses tras la intervención) en ambos grupos. 3. Comparar el tiempo libre de recurrencias entre ambos grupos. 4. Determinar variables clínicas y demográficas que pudieran influir en una mejor respuesta clínica. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients of both genders with ages between 18 and 70 years. 2. Patients with clinical and/or radiological images of bladder tumor with indication of RTUV. 3. Patients with a history of NMIUC in stage: Ta/T1, G1-G3, without concomitant CIS (Carcinoma in situ), with a disease-free period of at least 6 months. 4. Score on the Karnofsky scale > 70%. 5. Patients who agree to participate in the study by signing informed consent. |
1. Pacientes de ambos sexos con edades comprendidas entre 18 y 70 años. 2. Pacientes con evidencia clínica y/o de imágenes de tumor vesical con indicación de RTUV. 3. Pacientes con antecedente de CVNMI en estadio: Ta/T1, G1-G3, sin CIS (Carcinoma in situ) concomitante, siempre que tengan un período libre de enfermedad de al menos 6 meses. 4. Puntaje en la escala de Karnofsky > 70%. 5. Pacientes que estén de acuerdo en participar en el estudio mediante la firma del consentimiento informado. |
|
E.4 | Principal exclusion criteria |
1. Solid-looking or invasive muscle tumors on cystoscopy and/or preoperative imaging tests. 2. Patients in whom it is expected that follow-up will not be possible for any reason. 3. Patients that for any reason should not be included in the study according to individual evaluation of the research team. |
1. Tumores de aspecto sólido o músculo invasivo en la cistoscopia y/o pruebas de imagen preoperatorias. 2. Pacientes en los que se prevea que no va a ser posible el seguimiento por cualquier motivo. 3. Pacientes que por cualquier motivo no deberían ser incluidos en el estudio según evaluación individual del equipo investigador. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Rate of early recurrence of NMIUC. |
Tasa de recurrencia temprana de CVNMI. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1. Adverse events. 2. Demographic characteristics (age, sex). 3. Clinical characteristics (TNM classification, risk group, time of evolution, previous treatments received). |
1. Eventos adversos. 2. Características demográficas (edad, sexo). 3. Características clínicas (clasificación TNM, grupo de riesgo, tiempo de evolución, tratamientos previos recibidos). |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Resección transuretral de vejiga |
Transurethral resection of the bladder |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
Última visita del último sujeto |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |