Bladder CancerPhase 3NCT00553345
Selenium and Vitamin E in Preventing Cancer Progression and Recurrence in Patients With Early-Stage Bladder Cancer
A Phase 3 study testing selenium, vitamin E and chemoprevention in people with Bladder Cancer, run by University of Birmingham at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- selenium, vitamin E and chemoprevention
- Type of treatment
- Surgery or procedure
- How many people
- 515 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2005to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Birmingham
Birmingham, England, B15 2TT
Maurice Zeegers, 44 -121- 414- 6721
About this study
Official title: Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [TREATMENT]
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.
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- selenium, vitamin E, chemoprevention
- Keywords
- transitional cell carcinoma of the bladder, stage 0 bladder cancer, stage I bladder cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
seleniumDrug
vitamin EDrug
chemopreventionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free interval
Secondary outcomes (6)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2007 (estimated)
- Study startDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 515 participants
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Investigators
- Maurice Zeegers, Study chair, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553345
- Sponsor's protocol ID
- CDR0000574080
- Other IDs
- CRUK-BCPP-2005-01-TREATMENT, ISRCTN13889738, EU-20768
- Status last verified
- Feb 2010
- First submitted
- 2 Nov 2007
- Last updated
- 10 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [TREATMENT]
- ClinicalTrials.gov ID
- NCT00553345
- Acronym / sponsor ID
- CDR0000574080
- Conditions
- Bladder Cancer
- Keywords
- transitional cell carcinoma of the bladder, stage 0 bladder cancer, stage I bladder cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 515 participants
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- Dec 2005
- First posted
- 5 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| selenium | Drug | – |
| vitamin E | Drug | – |
| chemoprevention | Procedure or surgery | – |
Primary outcome
Recurrence-free interval
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurice Zeegers study chair
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing selenium, vitamin E and chemoprevention in people with Bladder Cancer, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free interval. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2014.