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Sponsored by: |
University Hospital Birmingham |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00553345 |
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.
Condition | Intervention | Phase |
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Bladder Cancer |
Drug: selenium Drug: vitamin E Procedure: chemoprevention |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Official Title: | Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [TREATMENT] |
Estimated Enrollment: | 1200 |
Study Start Date: | December 2005 |
OBJECTIVES:
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.
In all arms, treatment continues for 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Histopathologically confirmed non-muscle-invasive transitional cell carcinoma (< pT2)
Must meet 1 of the following recurrence risk criteria:
Intermediate risk
High risk
Exclusion criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United Kingdom, England | |
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust | Recruiting |
Birmingham, England, United Kingdom, B15 2TH | |
Contact: K. K. Cheng, MD 44-121-414-6757 |
Study Chair: | K. K. Cheng, MD | University Hospital Birmingham |
Study ID Numbers: | CDR0000574080, CRUK-BCPP-2005-01-TREATMENT, ISRCTN13889738, EU-20768 |
Study First Received: | November 2, 2007 |
Last Updated: | November 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00553345 |
Health Authority: | Unspecified |
transitional cell carcinoma of the bladder stage 0 bladder cancer stage I bladder cancer |
Tocopherol acetate Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Disease Progression Urogenital Neoplasms Carcinoma, Transitional Cell Urologic Neoplasms Transitional cell carcinoma |
Recurrence Alpha-Tocopherol Carcinoma Tocopherols Selenium Vitamin E Urologic Diseases Urinary tract neoplasm Bladder neoplasm |
Neoplasms Antioxidants Neoplasms by Site Molecular Mechanisms of Pharmacological Action Vitamins Growth Substances |
Physiological Effects of Drugs Trace Elements Micronutrients Protective Agents Pharmacologic Actions |