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Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer

This study is currently recruiting participants.
Verified June 2009 by National Cancer Institute (NCI)
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00729287
First received: August 6, 2008
Last updated: November 10, 2009
Last verified: June 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
 Dietary Supplement: selenium
Other: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase III Randomized Chemoprevention Study of Selenium on the Recurrence of Non-invasive Bladder Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Effect of selenium in preventing the recurrence of bladder cancer [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of selenium on the recurrence of bladder cancer, in terms of histological type, number, and size [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: June 2008
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm I
Patients receive oral placebo daily in addition to standard care.
 Other: placebo
Given orally
Experimental: Arm II
Patients receive oral selenium daily in addition to standard care.
 Dietary Supplement: selenium
Given orally

Detailed Description:

OBJECTIVES:

Primary

  • To determine the effect of selenium, when administered with standard care, in preventing the recurrence of bladder cancer in patients with non-muscle-invasive transitional cell carcinoma of the bladder at risk for recurrence.

Secondary

  • To determine the effect of selenium on the recurrence of bladder cancer, in terms of histological type, number, and size.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral placebo daily in addition to standard care.
  • Arm II: Patients receive oral selenium daily in addition to standard care.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729287

Locations
Belgium
U.Z. Gasthuisberg Recruiting
Leuven, Belgium, B-3000
Contact: Frank Buntinx, MD     32-16-337-493        
Sponsors and Collaborators
U.Z. Gasthuisberg
Investigators
Principal Investigator: Frank Buntinx, MD U.Z. Gasthuisberg
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Frank Buntinx, U.Z. Gasthuisberg
ClinicalTrials.gov Identifier: NCT00729287     History of Changes
Other Study ID Numbers: CDR0000602239, UZG-CUL-UHG-Non-InvasiveBladde, EU-20870
Study First Received: August 6, 2008
Last Updated: November 10, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage 0 bladder cancer
stage I bladder cancer
transitional cell carcinoma of the bladder

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Recurrence
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes
 Selenium
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on May 22, 2013