E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
NON MUSCULAR INVASIVE BLADDER CANCER WITH INTERMEDIATE RISK OF RECURRENCE |
TUMOR VESICAL NO MÚSCULO INVASIVO CON RIESGO INTERMEDIO DE RECURRENCIA |
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E.1.1.1 | Medical condition in easily understood language |
SUPERFICIAL BLADDER CANCER |
CÁNCER VESICAL SUPERFICIAL |
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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 the efficacy in terms of disease-free survival after 24 months of follow of hyperthermic vs. non hyperthermic intravesical instillation with Mitomycin |
Comparar la eficacia en términos de supervivencia libre de enfermedad tras 24 meses de seguimiento de instilación intravesical con Mitomicina hipertérmica vs. no hipertérmica |
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E.2.2 | Secondary objectives of the trial |
To compare the tolerability, recurrence rate, time to progression and quality of life after 24 months of follow up, of hyperthermic vs non hyperthermic intravesical chemotherapy |
Comparar la tolerabilidad, tasa de recurrencia, tiempo hasta progresión y calidad de vida, tras 24 meses de seguimiento, de instilación intravesical con Mitomicina hipertérmica vs. no hipertérmica |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. New or Recurrence of intermediate risk NMIBC following TURBT defined as; ? Grade 2 or grade 1 stage T1 disease ? Any grade G2 or G1 other than Low risk 2. Age ? 18 yrs 3. WHO performance status 0, 1, 2, 3 4. Normal kidneys and ureters on imaging study within the past 12 months** 5. Pre-treatment haematology and biochemistry values within acceptable limits: - haemoglobin ? 10 g/dl - neutrophil count ? 1.5 x 109/l - platelets ? 100 x 109/l - WBC ? 3.0 x 109/l or ANC ? 1.5 x 109/l - Serum creatinine < 1.5 x UNL 6. Negative pregnancy test for women of child-bearing potential. 7. Available for long-term follow-up. 8. Written informed consent. |
1. Paciente con TVNMI nuevo o recurrente al que se haya practicado RTU con riesgo intermedio de recidiva definido como ? Grado 2 o Grado 1 estadío T1* ? Cualquier Grado 1 o Grado 2 que no sea bajo riesgo 2. Escala WHO 0, 1, 2, 3 3. Pacientes mayores de 18 años 4. Pacientes con riñones y uréteres normales según prueba de imagen realizada en los últimos 12 meses 5. Pacientes con valores hematológicos y bioquímicos pre-tratamiento dentro de los límites aceptables: ? Hemoglobina ?10g/dl ? Neutrófilos ? 1.5 x 109/l ? Plaquetas ? 100 x 109/l ? WBC ? 3.0 x 109/l ó ANC ? 1.5 x 109/l ? Creatinina Sérica < 1.5 x UNL 6. Test de embarazo negativo en mujeres en edad fértil con alguna posibilidad de estar embarazadas. 7. Con posibilidad de realizar seguimiento a largo plazo. 8. Pacientes que hayan firmado el consentimiento informado |
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E.4 | Principal exclusion criteria |
1. Patients with any of the following conditions: - Grade 3 UCC. - CIS - Primary Solitary Ta G1<3cm - Primary Solitary Ta G2 <3cm 2. ?T2 UCC 3. Previous intravesical chemotherapy in the past 6 months, other than single instillation post-TUR. 4. History of limited vesical capacity (<200cc) 5. UCC involving the prostatic urethra or upper urinary tract. 6. Known allergy to MMC 7. Pregnant or lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception. 8. Other malignancy within the past five years, except: non-melanomatous skin cancer cured by excision, adequately treated carcinoma in situ of the cervix or DCIS/LCIS of the breast or prostate cancer with less than 5yrs life expectancy. 9. Patients with tumours histologically different tan transitional cell carcinoma 10. Concurrent chemotherapy. |
1. Pacientes con alguna de las siguientes características ? Grado 3 TCC ? CIS ? Tumor primario único TaG1<3cm ? Tumor primario único TaG2<3cm 2. Pacientes con estadiaje >T2 TCC 3. Pacientes que hayan sigo tratados con quimioterapia intravesical en los últimos 6 meses excepto aquellos que hayan recibido únicamente instilación inmediata post RTU 4. Pacientes con hipersensibilidad o alergia a MMC 5. Pacientes con capacidad vesical limitada inferior a 200c.c. 6. Carcinoma de células uroteliales comprometiendo uretra prostática o tracto urinario superior 7. Mujeres embarazadas o en período de lactancia o mujeres en edad fértil que no deseen o no puedan usar anticonceptivos no hormonales 8. Pacientes con otros tumores malignos en los últimos 5 años excepto cáncer de piel no melanomatoso curado por escisión, carcinoma in situ de cérvix tratado adecuadamente, carcinoma in situ ductal o lobular (DCIS/ LCIS) de cáncer de mama o próstata con menos de 5 años de esperanza de vida 9. Pacientes con tumores histológicamente diferentes al carcinoma transicional de vejiga. 10. Pacientes que por cualquier motivo deban recibir quimioterapia de forma simultánea. |
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E.5 End points |
E.5.1 | Primary end point(s) |
EFFICACY PARAMETERS
? Disease-free survival ? Recurrence rate ? Time to progression |
PARÁMETROS DE EFICACIA: ? Supervivencia libre de enfermedad ? Tasa de recurrencia ? Tiempo hasta la progresión |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Cystoscopy at the end of the treatment and at 4, 8, 12, 18 and 24 months of follow up |
Cistoscopia al final del tratamiento y a los 4, 8, 12, 18 y 24 meses de seguimiento |
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E.5.2 | Secondary end point(s) |
Safety Parameters - Dysuria, Urinary frequency, nocturia by IPSS scale - Graded visual pain scale (VAS) - Others reported by the health professional - EORTC Quality of Life Questionnaire QLQ-BLS24 |
PARÁMETROS DE SEGURIDAD - Disuria, Polaquiuria, nicturia mediante escala IPSS - Escala visual de dolor graduada (VAS) - Otros manifestados por el profesional sanitario (dificultad de sondaje, hematuria, rash cutáneo, calor) - Calidad de Vida Cuestionario EORTC QLQ-BLS24 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
? Before each new instillation: the patient will report any side effect occurred from the last instillation. ? After the instillation: - the patient will report any side effect occurred during the present instillation. - healthcare professional will report any other side effect occurred during the present instillation. ? The quality of life questionnaire will be completed by the patients before receiving adjuvant treatment and repeated in the last study visit. |
? Antes de cada nueva instilación el paciente reportará el estado miccional desde la última dosis ? Al finalizar la instilación: - el paciente reportará la sensación de dolor de la instilación recibida - el profesional sanitario evaluará cada una de los ciclos recibidos de forma independiente ? El cuestionario de calidad de vida será cumplimentado por el pacientes antes de recibir el tratamiento adyuvante y se repetirá en la última visita del estudio. |
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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 | 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 | 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 device |
Device assisted therapy |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 7 |
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
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LVLS |
Ultima visita último sujeto |
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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 | |