Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [TREATMENT]
18 Years
N/A
Both
Bladder Cancer
Trial Information
Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [TREATMENT]
OBJECTIVES:
- To investigate whether selenium and/or vitamin E (α-tocopherol) supplementation reduces
the risk of recurrence and progression.
OUTLINE: This is a multicenter study. Patients are stratified by recurrence risk group (high
vs intermediate) and treatment center and randomized to 1 of 4 treatment arms.
- Arm I: Patients receive oral selenium tablet and oral vitamin E capsule once daily.
- Arm II: Patients receive oral selenium tablet and oral placebo capsule once daily.
- Arm III: Patients receive oral placebo tablet and oral vitamin E capsule once daily.
- Arm IV: Patients receive oral placebo tablet and oral placebo capsule once daily.
In all arms, treatment continues for up to 5 years in the absence of disease progression or
unacceptable toxicity.
Quality of life is assessed every 6 months for 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histopathologically confirmed non-muscle-invasive transitional cell carcinoma (< pT2)
- Newly diagnosed disease
- Able to be randomized within twelve months of diagnostic transurethral resection
bladder tumor/biopsy
- Must meet 1 of the following recurrence risk criteria:
- Intermediate risk
- Multiple G1 pTa (> 1)
- Solitary G1 pTa (≥ 3 cm)
- G2 pTa
- G1 pT1
- G2 pT1 (1 or 2 tumors)
- High risk
- G3 pTa
- G3 pT1
- Cis
- Multiple G2 pT1 (3 or more foci)
- Low risk
- Solitary G1 pTa < 3 cm
PATIENT CHARACTERISTICS:
- Not pregnant or breast feeding
- No HIV infection
- No condition that, in the opinion of the local investigator, might interfere with the
safety of the patient or evaluation of the trial objectives
PRIOR CONCURRENT THERAPY:
- No concurrent immunosuppressive therapy after organ transplantation
- No concurrent cyclosporine
- Those who currently use or have used selenium and/or vitamin E supplements will not
be excluded, however, they must agree not to take supplements containing selenium and
vitamin E above a pre-specified dosage
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Outcome Measure:
Recurrence-free interval
Principal Investigator
Maurice Zeegers
Investigator Role:
Study Chair
Investigator Affiliation:
University of Birmingham
Authority:
Unspecified
Study ID:
CDR0000574080
NCT ID:
NCT00553345
Start Date:
December 2005
Completion Date:
Related Keywords:
- Bladder Cancer
- transitional cell carcinoma of the bladder
- stage 0 bladder cancer
- stage I bladder cancer
- Urinary Bladder Neoplasms
Name | Location |
|---|
