E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
Superficial bladder cancer |
Cáncer vesical superficial |
|
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 |
COMPARE EFFICACY OF NEOADJUNCTIVE THERAPY WITH CHEMO-HYPERTHERMIA WITH STANDARD ADJUNCTIVE THERAPY FOR NMIBT AT 24 MONTHS |
COMPARAR LA EFICACIA DEL TRATAMIENTO NEOADYUVANTE CON QUIMIIO-HYPERTHERMIA CON TRATAMIENTO ADYUVANTE ESTÁNDAR PARA EL TVNMI A LOS 24 MESES |
|
E.2.2 | Secondary objectives of the trial |
EVALUATE EFFICACY OF NEOADJUNCTIVE THERAPY IN TERMS OF COMPLETE AND PARTIAL RESPONSE AND COMPARE TOLERABILITY, QOL AND COST EFFECTIVENESS OF BOTH TREATMENT REGIMES |
EVALUAR EFICACIA EN TÉRMINOS DE RESPUESTA PARCIAL Y COMPLETA DEL TRATAMIENTO NEOAYUVANTE Y COMPARAR TOLERABILIDAD, CALIDAD DE VIDA Y COSTE EFECTIVIDAD DE AMBOS REGÍMENES DE TRATAMIENTO |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients with NMIBC for which TURB is indicated except those recurrent with previous T1G3 or CIS in the last 12 moths and positive cytology - WHO scale 0, 1, 2, 3 - Age ? 18 yrs - Normal kidneys and ureters - Pre-treatment haematology and biochemistry values within acceptable limits - Negative pregnancy test for women of child-bearing potential - Written informed consent (IC) |
- Paciente con TVNMI con indicación de próxima RTU vesical excepto paciente recurrente con T1G3 ó CIS previo en los últimos 12 meses y citología positiva. - Escala WHO 0, 1, 2, 3 - Pacientes mayores de 18 años - Pacientes con vía urinaria superior normal - Pacientes con valores hematológicos y bioquímicos pre-tratamiento dentro de los límites aceptables - Test de embarazo negativo en mujeres en edad fértil con alguna posibilidad de estar embarazadas - Pacientes que hayan firmado el consentimiento informado (CI) |
|
E.4 | Principal exclusion criteria |
- Patient with solid tumor and muscle infiltrating aspect or with associated plane lesions suspicious for CIS - Recurrent patients with previous T1G3 or CIS in the last 12 months and positive cytology - Patients with hypersensitivity or allergy to MMC - History of limited vesical capacity (<200cc) - UCC involving the prostatic urethra or upper urinary tract - Pregnant or lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception - Other malignancy within the past five years, except: nonmelanomatous skin cancer cured by excision, adequately treated carcinoma in situ of the cervix or DCIS/LCIS of the breast or prostate cancer. cancer. - Patients with tumours histologically different tan transitional cell carcinoma - Patients that for any reason should receive concurrent chemotherapy |
- Pacientes con tumor sólido y aspecto músculo infiltrante o con lesiones planas asociadas sospechosas de CIS - Pacientes recurrentes con T1G3 ó CIS previo en los últimos 12 meses y citología positiva. - Pacientes con hipersensibilidad o alergia a MMC - Pacientes con capacidad vesical limitada inferior a 200c.c. - Carcinoma de células uroteliales comprometiendo uretra prostática o tracto urinario superior - Mujeres embarazadas o en período de lactancia o mujeres en edad fértil que no deseen o no puedan usar anticonceptivos no hormonales - Pacientes con otros tumores malignos en los últimos 5 años excepto cáncer de piel no melanomatoso curado por escisión, carcinoma in situ de cérvix, carcinoma in situ ductal o lobular (DCIS/ LCIS) de cáncer de mama o cáncer de próstata tratados adecuadamente. - Pacientes con tumores histológicamente diferentes al carcinoma transicional de vejiga - Pacientes que por cualquier motivo deban recibir quimioterapia de forma simultánea |
|
E.5 End points |
E.5.1 | Primary end point(s) |
DFSR (Disease Free Survival Rate) |
TLE (Tiempo Libre de Enfermedad) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Cytoscopy at week 4 and at 4, 8, 12, 18 and 24 months after treatment completion |
Cistoscopia a la semana 4 y al mes 4, 8, 12, 18 y 24 meses de seguimiento |
|
E.5.2 | Secondary end point(s) |
Complete and partial response of neoadjunctive therapy, tolerability, quality of life and cost effectiveness |
Respuesta parcial y completa del tratamiento neoayuvante, tolerabilidad, calidad de vida y coste efectividad |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Cytology at week 4, side effects reported by patient and healthcare professional before and after every instillation, qol questionnaire at screening visit and last visit. |
Citología en la semana 4, efectos secundarios reportados por profesional sanitario y paciente antes y después de cada instilación, cuestionario calidad de vida en la visita de screening y última visita |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
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 |
Terapia asistida por equipo |
Device assiisted therapy |
|
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |