Clinical trial NCT00553345: Selenium and Vitamin E in Preventing Cancer Progression and Recurrence in Patients With Early-Stage Bladder Cancer
Official title: Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [TREATMENT]
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Bladder Cancer
Keywords: transitional cell carcinoma of the bladder
stage 0 bladder cancer
stage I bladder cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-11-04
Enrollment: 515
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Recurrence-free interval
Secondary outcomes:
measure: Overall survival time
measure: Incidence of transitional cell carcinoma outside the bladder
measure: Incidence of all other malignancies clinically diagnosed
measure: Incidence of cardiovascular events
measure: Quality of life as assessed at each follow-up visit by the quality of life instruments EORTC QLQ-C30, QLQ-BLS24 and QLQ-BLM30
measure: Progression-free interval
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University of Birmingham
state: England
Study officials:
affiliation: University of Birmingham
name: Maurice Zeegers
role: STUDY_CHAIR
References: