BCPP - bladder cancer (superficial and invasive)
Conditions
Interventions
Patients are randomised to receive one of the following:
1. Selenium and vitamin E placebo
2. Selenium placebo and vitamin E (alpha-tocopherol)
3. Selenium and vitamin E (alpha-tocopherol)
4. Selenium
Sponsors
University of Birmingham (United Kingdom)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for SELENIB Trial: 1. Able to give informed consent for SELENIB 2. Previously registered onto the Bladder Cancer Prognosis Programme 3. Disease characteristics: histopathologically confirmed non-muscle invasive transitional cell carcinoma. Solitary grade 1 pTa larger than 3 cm and all other stage pTa, pT1 or pTcis
Exclusion criteria
Exclusion criteria: Exclusion criteria for SELENIB trial: 1. Disease characteristics - solitary grade 1 pTa <3 cm or stage pT2 and above 2. Patients that are pregnant or breastfeeding 3. Patients diagnosed with human immunodeficiency virus (HIV) infection 4. Patients who are on immunosuppressive therapy following organ transplantion 5. Patients taking cyclosporin 6. Any condition, which, in the opinion of the local investigator, might interfere with the safety of the patient or evaluation of the trial objectives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SELENIB trial - primary outcomes 1. Recurrence-free interval 2. Progression-free interval Progression is defined as a recurrence with: 1. An increase in grade from grade 1/grade 2 to grade 3 2. An increase in tumour, node, metastasis (TNM) stage 3. The new occurrence of carcinoma in situ (CIS) in a bladder previously free from such lesions 4. The new occurrence of multiple urothelial tumours following resection of a solitary urothelial tumour 5. The need for a cystectomy because of refractory disease | — |
Secondary
| Measure | Time frame |
|---|---|
| SELENIB trial - secondary outcomes 1. All cause mortality 2. Incidence of transitional cell carcinoma (TCC) outside the bladder - we expect pathological confirmation will be available in most cases but a diagnosis based on strong clinical, radiological and cytological evidence will be acceptable 3. Incidence of all other malignancies clinically diagnosed - they may be pathologically confirmed or diagnosed based on strong clinical, radiological, laboratory marker or cytological evidence 4. Incidence of cardiovascular events: a. Myocardial infarction - the patient must have symptoms meeting World Health Organization (WHO) criteria and the event associated with abnormal levels of cardiac enzymes or diagnostic electrocardiograms (ECGs)b. Stroke - the patient must have a new neurological deficit of sudden onset that has persisted for more than 24 hours or until death within 24 hours c. Death from cardiovascular causes - this will be confirmed by autopsy reports, death certificates or medical records 5. Quality of life - as assessed by the quality of life instruments: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-BLS24 and QLQ-BLM30 | — |
Countries
England, United Kingdom
Contacts
Public ContactBen Abbotts
Outcome results
None listed