Selenium and Vitamin E in Preventing Cancer Progression and Recurrence in Patients With Early-Stage Bladder Cancer

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. Quality of life is assessed every 6 months for 5 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK.

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

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Drug: selenium
* Drug: vitamin E
* Procedure: chemoprevention


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: selenium|nan|
|Drug: vitamin E|nan|
|Procedure: chemoprevention|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free interval |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival time |  |  | 
| Incidence of transitional cell carcinoma outside the bladder |  |  | 
| Incidence of all other malignancies clinically diagnosed |  |  | 
| Incidence of cardiovascular events |  |  | 
| 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 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transitional cell carcinoma of the bladder, stage 0 bladder cancer, stage I bladder cancer