E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
locally advanced rectal cancer |
cancro del retto localmente avanzato |
|
E.1.1.1 | Medical condition in easily understood language |
locally advanced rectal cancer |
cancro del retto localmente avanzato |
|
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 |
Increase of the complete response rate with the aim of organ sparing. Evaluated by histopathological analysis based on TRG performed on specimen exported from local excision. |
Incremento del tasso di risposta completa istopatologica del braccio di trattamento rispetto al braccio di controllo |
|
E.2.2 | Secondary objectives of the trial |
a) Local recurrence rate b) Pain control c) Quality of life d) Electrochemotherapy toxicity
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a) tasso di recidiva locale b) controllo del dolore c) qualità di vita d) tossicità dell’elettrochemioterapia
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
a) Male or female patients aged > 18 years b) Histological confirmation of rectal adenocarcinoma c) Patients undergoing neoadjuvant treatment for locally advanced tumor of the rectum with confirmed major clinical response after neoadjuvant treatment d) Rectal tumor up to 12 cm from the external anal margin e) Patients must be willing to comply with the study protocol and give their informed written consent. f) Patients with an ECOG status performance <3
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a) Pazienti maschio o femmina età >18 anni b) Neoplasia con conferma istologica di adenocarcinoma del retto c) Pazienti sottoposti a trattamento neoadiuvante per tumore localmente avanzato del retto con risposta clinica maggiore alla ristadiazione d) Neoplasia a massimo 12 cm dal margine anale esterno e) Disponibilità a rispettare il protocollo di studio e dare il loro consenso informato scritto. f) I pazienti con una ECOG status performance <3
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E.4 | Principal exclusion criteria |
a) Age less than 18 years b) Patients with neoplasia more than 12 cm from the anal margin c) Patients with stable disease or disease progression after neoadjuvant treatment d) Patients, who for medical reasons, cannot be given bleomycin e) Lesions not suitable for ECT (bony invasion, large vessels infiltration, etc.); f) Acute lung infection; g) Symptoms of poor lung function; h) Non correctable severe coagulation disorders; i) Previous allergic reactions to bleomycin; j) Previous cumulative dose of 250 mg/m2 of bleomycin exceeded; k) Chronic renal dysfunction (creatinine> 150 µmol/L must be considered a lower administered dose of bleomycin) l) Pregnancy or lactation**
**Pregnancy has been established prior to enrolment by beta-HCG assay on urine (pregnancy test or urinary beta-HCG) or blood (plasma beta-HCG).
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a) Età inferiore ai 18 anni b) Pazienti con neoplasia a oltre 12 cm dal margine anale c) Pazienti valutati come con malattia stabile o progressione di malattia alla ristadiazione dopo trattamento neoadiuvante d) Pazienti che per ragioni mediche non possono ricevere la bleomicina e) Infezione polmonare acuta f) Scarsa funzionalità polmonare o funzionalità anomala g) Disordini importanti della coagulazione h) Allergia alla bleomicina i) Dosi cumulative di 250 mg/m2 di bleomicina ricevuta l) Disfunzione renale cronica (creatinina> 150 µmol/L) m) Qualsiasi malattia sistemica grave e incontrollata n) Gravidanza o allattamento**
**Lo stato di gravidanza è stato accertato prima dall’arruolamento mediante il dosaggio della Beta-HCG sulle urine (Test di gravidanza o beta-HCG urinaria) o sul sangue (beta-HCG plasmatica).
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E.5 End points |
E.5.1 | Primary end point(s) |
Incremento del tasso di risposta completa istopatologica del braccio di trattamento rispetto al braccio di controllo |
Incremento del tasso di risposta completa istopatologica del braccio di trattamento rispetto al braccio di controllo |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At visit 4 (37 ± 5 days from treatment) |
Alla visita 4 (37 ± 5 giorni dal trattamento) |
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E.5.2 | Secondary end point(s) |
a) Local recurrence rate b) Pain control c) Quality of life d) Electrochemotherapy toxicity
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a) tasso di recidiva locale b) controllo del dolore c) qualità di vita d) tossicità dell’elettrochemioterapia
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
For end points a) the detection will be performed at 60 months from the treatment while for the end points b), c) and d) at each follow-up visit for the 24 months following the treatment |
Per end point a) la rilevazione sarà eseguita a 60 mesi dal trattamento mentre per gli end point b), c) e d) ad ogni visita di follow-up per i 24 mesi successivi al trattamento |
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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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
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 |
Il gruppo di controllo farà la chirurgia come da pratica clinica |
The control group will do the surgery as per clinical practice |
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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
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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 | 8 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 8 |