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Clinical Trials/NCT00553345
NCT00553345UnknownPhase 3

Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [TREATMENT]

University of Birmingham2 sites in 1 country515 target enrollmentStarted: December 2005Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Enrollment
515
Locations
2
Primary Endpoint
Recurrence-free interval
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Primary Purpose
Prevention
Masking
Double

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor Class
Other

Study Sites (2)

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