Bladder Cancer
Conditions
Keywords
transitional cell carcinoma of the bladder, stage 0 bladder cancer, stage I bladder cancer
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.
Interventions
Sponsors
University of Birmingham
Study design
Allocation
RANDOMIZED
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free interval | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
| Incidence of cardiovascular events | — |
Countries
United Kingdom
Outcome results
None listed