E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
high grade non muscle invasive bladder cancer |
cancro alla vescica non muscolo-invasivo ad alto rischio |
|
E.1.1.1 | Medical condition in easily understood language |
high grade non muscle invasive bladder cancer |
cancro alla vescica non muscolo-invasivo ad alto rischio |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10005003 |
E.1.2 | Term | Bladder cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
COMPARISON OF WHITE LIGHT TUR VS PHOTODYNAMIC DIAGNOSIS (PDD)- GUIDED TUR AS ASSESSED BY SECOND LOOK TUR FOR THE TREATMENT OF HIGH RISK NON MUSCLE INVASIVE BLADDER CANCER (NMIBC)
|
Impatto dell’utilizzo dell’acido Examinolevulinico nel corso della prima resezione endoscopica (PDD-TURBT) rispetto alla resezione standard in luce bianca (WL-TURBT) nella riduzione della malattia residua alla seconda TURBT nei pazienti affetti da NMIBC ad alto grado |
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E.2.2 | Secondary objectives of the trial |
Time to first recurrence and Time to progression (18 month follow up) |
tempo alla prima recidiva e
tempo alla progressione ad un follow-up minimo di 18 mesi
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age between 30-80 years;
- Male and Female;
- Suspicion of high grade (Ta/T1) or CIS non muscle invasive bladder tumour with positive cytology
-Suspicion of high grade (Ta/T1) or CIS non muscle invasive bladder tumour cystoscopy on-going or suspected ecography
-Written Voluntary Consent of the subject
|
- età compresa tra 30 e 80 anni
- pazienti di entrambi i sessi
- sospetto tumore vescicale transizionale non-muscolo invasivo di alto grado (Ta/T1) o CIS da citologia positiva
- sospetto tumore vescicale transizionale non-muscolo invasivo di alto grado (Ta/T1) o CIS in corso di cistoscopia o ecografia sospetta per neoplasia vescicale
- Consenso Informato volontario firmato dal paziente
|
|
E.4 | Principal exclusion criteria |
- Endovesical BCG performed < 4 months before
- Lesions >3 cm in size
- Presence of more than 2 lesions
- Bladder stones
- Upper urinary tract involvement
- Concomitant second cancer
- Unwilling or unable to comply with study requirement including follow up treatment
- Pregnancy or Breast-feeding
- Hypersensitivity to the active principle or to any of the excipients (disodium phosphate dihydrate, potassium dihydrogen phosphate, sodium chloride, hydrochloric acid, sodium hydroxide)
- Porphyria documented
|
- Terapia Endovescicale con BCG effettuata entro 4 mesi prima della resezione endoscopica
- Neoformazioni vescicali >3 cm in diametro
- Presenza di più di 2 lesioni
- Concomitanza di calcoli renali
- Concomitante neoplasia delle vie urinarie superiori
- Concomitante seconda neoplasia
- Paziente non collaborativo o incapace di aderire alle procedure di studio inclusi trattamento e follow-up
- Donna in gravidanza o allattamento
- Ipersensibilità al principio attivo o a qualsiasi degli eccipienti (disodio fosfato diidrato; potassio diidrogeno fosfato; sodio cloruro; acido cloridrico; sodio idrossido)
- Porfiria documentata |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Definition of residual disease at second TUR (6-8 weeks) in both groups.
For residual disease means, unequivocally, the presence of at least one cell compatible with urothelial neoplasm (of any grade and stage) in the sample after the second TUR using the WHO / ISUP 2004 classification. |
Definizione di malattia residua alla resezione transuretrale secondaria ( a 6-8 settimane) in entrambi i gruppi.
Per malattia residua si intende, univocamente, la presenza di almeno una cellula compatibile con neoplasia uroteliale (di qualunque grado e stadio) nel campione analizzato dopo seconda TUR utilizzando la classificazione WHO/ISUP 2004. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Definition of time to first recurrence and progression in the two groups of patients at 18 month follow-up |
Definzione del tempo alla prima recidiva e alla progressione nei due gruppi di pazienti a 18 mesi di follow-up. |
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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 | Yes |
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 | No |
E.8.1.3 | Single blind | Yes |
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 |
Al gruppo di controllo non viene somministrato farmaco diagnostico |
The comparator group is without medicinal product |
|
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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |