NON-MUSCLE INVASIVE BLADDER CANCER
Conditions
Interventions
Trade Name: Hexvix
Product Name: Hexvix
Pharmaceutical Form: Powder for bladder irrigation
INN or Proposed INN: Hexyl(5-amonio-4oxopentanoat)
Concentration unit: mmol/l millimole(s)/litre
Concentratio
Sponsors
Free state of Bavaria
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 125
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: 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.;Primary end point(s): The final analysis will be conducted after at least 93 observed recurrences (=target events);Timepoint(s) of evaluation of this end point: every three months up to one year altogether | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. ;Timepoint(s) of evaluation of this end point: every three months up to one year altogether | — |
Countries
Austria, Germany
Contacts
Public ContactDr. Josef Reisinger
multi-service-monitoring
Outcome results
None listed