Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [TREATMENT]
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Bladder Cancer
- Sponsor
- University of Birmingham
- Enrollment
- 515
- Locations
- 1
- Primary Endpoint
- Recurrence-free interval
- Last Updated
- 12 years ago
Overview
Brief Summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of selenium and vitamin E may stop cancer from growing or coming back.
PURPOSE: This randomized phase III trial is studying giving selenium together with vitamin E to see how well it works compared with a placebo in preventing cancer progression and recurrence in patients with early-stage bladder cancer.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Recurrence-free interval
Secondary Outcomes
- Incidence of cardiovascular events
- Incidence of transitional cell carcinoma outside the bladder
- Incidence of all other malignancies clinically diagnosed
- Overall survival time
- Quality of life as assessed at each follow-up visit by the quality of life instruments EORTC QLQ-C30, QLQ-BLS24 and QLQ-BLM30
- Progression-free interval