E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Multiple, Ta / T1, G1 / G2, non-muscle invasive bladder carcinoma |
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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 demonstrate that treatment of non-muscle invasive bladder carcinoma with incomplete TUR and Il-2 is therapeutically more effective than treatment with complete TUR and IL-2 |
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E.2.2 | Secondary objectives of the trial |
To establish the mechanism of action of incomplete TUR in combination with IL-2 instillations in patients with multiple, Ta / T1, G1 / G2, non-muscle invasive bladder carcinoma. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with a multiple (< 10) resectable Ta(G1,2) or T1(G1,2) transitional cell carcinoma of the bladder as diagnosed by pathological examination. |
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E.4 | Principal exclusion criteria |
- Excluded are patients with CIS, or a cancer type other than urothelial cell carcinoma, or with a second malignancy (except treated basal carcinoma of the skin), or a tumour in the prostatic urethra or in a diverticulum or in the upper urinary tract. - Patients who received local or systemic chemotherapy within 3 months before inclusion, or BCG within 6 months of inclusion, or any prior treatment with IL-2. - Patients who received local radiotherapy for any muscle invasive bladder cancer. - Patients who have recurrent severe bacterial or drug-induced cystitis. - Patients that received less than 3 months earlier systemically applied immune suppressive drugs. - Patients who require or are likely to require corticosteroids systemically or locally in the bladder or kidney for intercurrent disease. - HIV positive patients - Pregnancy or lactation. Or the patient is likely to become pregnant within 2 months after TUR.
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E.5 End points |
E.5.1 | Primary end point(s) |
1. The recurrence-free period after intervention. 2. The percentage of recurrence-free patients 2 years after intervention. 3. The percentage of complete regression of the marker tumours 3 months after intervention.
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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) | 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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 3 |
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 | 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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |