E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-muscle-invasive transitional cell carcinoma of the bladder |
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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 |
To investigate whether selenium and/or vitamin E (d-a-tocopherol) supplementation reduce the risk of recurrence and progression amongst patients with non-muscle-invasive bladder cancer. Primary Outcome Measure •Recurrence-free interval This is defined as time from date of trial entry to date of recurrence. For those patients who are not observed to have a recurrence by the time of analysis, the interval will be censored at date last known to be recurrence-free. A recurrence is defined as the new occurrence of a bladder cancer at the same or different site as the initial index primary cancer and excluding tumours identified at the first check cystoscopy. Recurrence at the 3-month follow up cystoscopy will be excluded as the majority of these “recurrences” are predominantly due to incomplete resection of the primary index tumour, and have little prospect of being affected by any chemoprevention. |
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E.2.2 | Secondary objectives of the trial |
Secondary Outcome Measures •Progression-free interval: this is defined as time from date of trial entry to date of progression. For those patients who are not observed to have a progression by the time of analysis, the interval will be censored at date last known to be progression-free. Our definition of progression includes important risk factors for “progression to muscle-invasive disease“, a clinically important endpoint. •Overall survival •Incidence of all other clinically-diagnosed malignancies •Incidence of cardiovascular events and diabetes •Death from cardiovascular causes •Quality of Life – as assessed at each follow-up visit by the quality of life instruments EORTC QLQ-C30, QLQ-BLS24 and QLQ-BLM30 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Able to give informed consent for SELENIB. - An initial diagnosis of: Histopathologically confirmed non-muscle-invasive transitional cell carcinoma (<pT2) (i.e. All stage pTa, pT1 or pTcis) - Diagnostic surgery (TURBT/biopsy) within the previous twelve months. |
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E.4 | Principal exclusion criteria |
• Disease characteristics – stage pT2 and above • Patients that are pregnant or breastfeeding • Patients diagnosed with HIV infection • Patients who are on immunosuppressive therapy following organ transplantion • Patients taking cyclosporin • Any condition which, in the opinion of the local investigator, might interfere with the safety of the patient or evaluation of the trial objectives. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Outcome Measure •Recurrence-free interval This is defined as time from date of trial entry to date of recurrence. For those patients who are not observed to have a recurrence by the time of analysis, the interval will be censored at date last known to be recurrence-free. A recurrence is defined as the new occurrence of a bladder cancer at the same or different site as the initial index primary cancer and excluding tumours identified at the first check cystoscopy. Recurrence at the 3-month follow up cystoscopy will be excluded as the majority of these “recurrences” are predominantly due to incomplete resection of the primary index tumour, and have little prospect of being affected by any chemoprevention. Secondary Outcome Measures •Progression-free interval: this is defined as time from date of trial entry to date of progression. For those patients who are not observed to have a progression by the time of analysis, the interval will be censored at date last known to be progression-free. Our definition of progression includes important risk factors for “progression to muscle-invasive disease“, a clinically important endpoint. Progression is defined as a RECURRENCE with: o an increase in grade from grade 1/grade 2 to grade 3, or o an increase in T-stage (determined by histopathology), or o the new occurrence of carcinoma in situ (CIS) in a bladder previously free from CIS, or o the new occurrence of multiple urothelial tumours following the initial diagnosis of a solitary urothelial tumour OR: o the need for a cystectomy because of refractory disease OR: o the new development of nodal and/or distant metastases (determined by imaging) •Overall survival •Incidence of all other clinically-diagnosed malignancies •Incidence of cardiovascular events and diabetes •Death from cardiovascular causes •Quality of Life – as assessed at each follow-up visit by the quality of life instruments EORTC QLQ-C30, QLQ-BLS24 and QLQ-BLM30 |
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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 | 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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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.8.5 | 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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
For the purposes of Clinical Trial Authorisation (CTA), under the European Union Directive 2001/20/EC, the study is deemed to have ended 30 days after the last patient receives the last dose of the investigational medicinal product (IMP) (selenium, vitamin E or placebo). The trial will then enter a follow-up phase. |
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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 | 9 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 9 |
E.8.9.2 | In all countries concerned by the trial months | 0 |