Bladder Cancer Clinical Trial
Official title:
Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [TREATMENT]
Verified date | February 2010 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | Unspecified |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 515 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Birmingham | Birmingham | England |
Lead Sponsor | Collaborator |
---|---|
University of Birmingham |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence-free interval | |||
Secondary | Overall survival time | |||
Secondary | Incidence of transitional cell carcinoma outside the bladder | |||
Secondary | Incidence of all other malignancies clinically diagnosed | |||
Secondary | Incidence of cardiovascular events | |||
Secondary | Quality of life as assessed at each follow-up visit by the quality of life instruments EORTC QLQ-C30, QLQ-BLS24 and QLQ-BLM30 | |||
Secondary | Progression-free interval | No |
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