Bladder Cancer Clinical Trial
Official title:
Phase III Randomized Chemoprevention Study of Selenium on the Recurrence of Non-invasive Bladder Cancer
Verified date | June 2009 |
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, growing,
or coming back. The use of selenium may keep bladder cancer from growing or coming back. It
is not yet known whether selenium is more effective than a placebo in preventing cancer
recurrence in patients with bladder cancer.
PURPOSE: This randomized phase III trial is studying selenium to see how well it works
compared with a placebo in preventing cancer recurrence in patients with bladder cancer.
Status | Recruiting |
Enrollment | 900 |
Est. completion date | |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histopathologically confirmed non-muscle-invasive transitional cell carcinoma (TCC) of the bladder (< pT2 ), meeting any of the following criteria: - Solitary grade 1, pTa (= 3 cm) tumor - Any other pTa, pTis (carcinoma in situ), or pT1 tumor - Newly diagnosed disease - Meets 1 of the following risk criteria for recurrence: - Intermediate-risk disease - Multiple grade 1, pTa (> 1) tumor - Solitary grade 1, pTa (= 3 cm) tumor - Grade 2, pTa tumor - Grade 1, pT1 tumor - Grade 2, pT1 (1 or 2 tumors) - High-risk disease - Grade 3, pTa tumor - Grade 3, pT1 tumor - Tis (carcinoma in situ) - Multiple grade 2, pT1 (= 3 foci) tumor - Has undergone diagnostic transurethral resection of the bladder tumor/biopsy within the past 3 months - No residual tumor, defined as a recurrence within 3 months after initial treatment (due to incomplete resection of the primary index tumor or implantation after biopsy) - No prostatic, prostatic urethral, or upper tract TCC involvement by the index tumor at resection - No muscle invasion or advanced disease - No metastatic disease PATIENT CHARACTERISTICS: - Able to swallow pills - Not pregnant - Fertile patients must use effective contraception - No other malignancy within the past 5 years - No known hypersensitivity or adverse reactions to selenium - No other serious medical or psychiatric illness that would preclude giving informed consent - No condition that, in the opinion of the investigator, may interfere with the safety of the patient or the evaluation of the study objectives PRIOR CONCURRENT THERAPY: - See Disease Characteristics - More than 30 days since prior daily dietary supplements containing selenium - No other concurrent selenium (contained in individual supplements, antioxidant mix, or multivitamin) intake - No concurrent participation in another study involving a medical, surgical, nutritional, or lifestyle intervention - Concurrent participation in the follow-up phase of another study allowed |
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | U.Z. Gasthuisberg | Leuven |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Gasthuisberg |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of selenium in preventing the recurrence of bladder cancer | No | ||
Secondary | Effect of selenium on the recurrence of bladder cancer, in terms of histological type, number, and size | No |
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