E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
NON-MUSCLE INVASIVE BLADDER CANCER |
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E.1.1.1 | Medical condition in easily understood language |
bladder cancer |
Blasenkrebs |
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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 |
The primary objective is to compare the recurrence-free survival in patients with intermediate risk non-muscle invasive bladder cancer undergoing Hexvix® assisted transurethral resection of the bladder (TURB) and subsequently treated with one immediate intravesical chemotherapy instillation versus standard white-light TURB and subsequently treated with immediate and maintenance intravesical chemotherapy |
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E.2.2 | Secondary objectives of the trial |
To demonstrate that health related quality of life in relation to Hexvix®- guided TURB followed by one immediate instillation exceeds health related quality of life in relation to white light guided TURB followed by immediate and maintenance adjuvant Mitomycin C instillation. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male and female patients over 18 years of age
• WHO performance state 0-2
• Normal upper urinary tract as documented by either ultrasound of the urinary tract, IV urography or Uro-CT-scan
• Able to understand and follow treatment scheme
• Signed and dated Informed Consent
• Cystoscopy demonstrating suspected non-muscle invasive urothelial bladder cancer with indication for TURB
• Recurrence score ≥ 1 according to EORTC risk tables for Ta/T1 bladder cancer based on Cystoscopy
• Progression score ≤ 13 according to EORTC risk tables for Ta/T1 bladder cancer based on Cystoscopy
• Willingness to apply adequate contraception (Pearl Index <1) for study duration.
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E.4 | Principal exclusion criteria |
• History of other active malignancy within previous five years, except adequately treated basal cell and squamous cell carcinoma of the skin and prostate cancer
• Other serious illness or medical conditions (e.g. history of significant cardiac or respiratory dysfunction)
• Patients with a contra-indication preventing adjuvant intavesical chemotherapy
• Known hypersensitivity to any of the components of the study drugs
• Pregnant or nursing women
• Untreated bacterial cystitis |
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E.5 End points |
E.5.1 | Primary end point(s) |
The final analysis will be conducted after at least 93 observed recurrences (=target events) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
every three months up to one year altogether |
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E.5.2 | Secondary end point(s) |
To demonstrate that health related quality of life in relation to Hexvix®- guided TURB followed by one immediate instillation exceeds health related quality of life in relation to white light guided TURB followed by immediate and maintenance adjuvant Mitomycin C instillation as demonstrated by the validated questionnaires EORTC QLQ-C30 and QLQ-BLS24.
To demonstrate that the superiority in health related quality of life is related to less frequent office visits, catheterization and Mitomycin C related side effects as demonstrated by a set of questions that follow the EORTC QLQ response format and that were specifically constructed for this study (HELENA-Treatment-Related-Bother-Score)
To demonstrate that Hexvix®-guided follow-up cystoscopy enhances detection of tumour recurrence as demonstrated by white-light cystoscopy followed by Hexvix®- guided cystoscopy in one patient serving as control (white-light cystoscopy) and case (Hexvix®-cystoscopy) and documentation of additional lesions visible by Hexvix®-cystoscopy in all patients regardless of treatment arm.
To evaluate by clonality analysis if recurring tumours in either arm stem from the initial tumours resected or represent novel neoplasia and if more thorough resection by Hexvix®- guided TURB would reduce occurrence from recurring tumours of the clone initially removed.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
every three months up to one year altogether |
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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 | 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 | 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 | 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 | Yes |
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 |
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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
| 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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 11 |
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 | 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
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See protocol section 5.6.1 |
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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 | 4 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |