Spots Global Cancer Trial Database for Surgery With or Without Chemotherapy in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer
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Trial Identification
Brief Title: Surgery With or Without Chemotherapy in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer
Official Title: Phase III Randomized Study of a Single Adjunctive Instillation of Intravesical AD 32 (N-Trifluoroacetyladriamycin-14-valerate) Versus No Adjunctive Therapy Immediately Following Transurethral Resection in Patients With Multiple Superficial (Ta/T1) Bladder Tumors
Study ID: NCT00003725
Conditions
Study Description
Brief Summary: RATIONALE: Transurethral resection is a less invasive type of surgery for bladder cancer and may have fewer side effects and improve recovery. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether transurethral resection plus AD 32 is more effective than transurethral resection alone for bladder cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of transurethral resection surgery followed by AD 32 with that of transurethral resection alone in treating patients who have newly diagnosed or recurrent bladder cancer.
Detailed Description: OBJECTIVES: I. Assess the efficacy of adjuvant AD 32 following complete transurethral resection versus transurethral resection alone in patients with newly diagnosed or recurrent superficial transitional cell carcinoma of the bladder. II. Assess the toxicity of AD 32 in these patients. OUTLINE: This is an open label, randomized, multicenter study. Patients are randomized to receive surgery with AD 32 or surgery alone. Arm I: Patients undergo surgery to remove bladder tumors. AD 32 is administered by catheter into the bladder within 2-24 hours after surgery. Patients must hold the AD 32 liquid in the bladder for 90 minutes. Arm II: Patients undergo only surgery to remove bladder tumors. Patients with T1 or Tis disease may receive BCG therapy once weekly for 6 weeks, followed by 6 weeks of rest. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: This study will accrue approximately 300 patients.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Urology Associates, Birmingham, Alabama, United States
Urology Associates, Ltd., Phoenix, Arizona, United States
University of California San Diego Cancer Center, La Jolla, California, United States
San Diego Urology Center, La Mesa, California, United States
Hillcrest Urological Medical Group, San Diego, California, United States
San Diego Urology Center, San Diego, California, United States
UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States
Santa Monica Urologic Medical Group, Santa Monica, California, United States
Western Urological Associates, Van Nuys, California, United States
Urology Specialists, P.C., Waterbury, Connecticut, United States
George Washington University Hospital, Washington, District of Columbia, United States
Atlantic Urological Associates, Daytona Beach, Florida, United States
University of Florida - Gainesville, Gainesville, Florida, United States
Sylvester Cancer Center, University of Miami, Miami, Florida, United States
Urology Care - South, Miami, Florida, United States
Urology Health Center, New Port Richey, Florida, United States
Office of Ira W. Klimberg, Ocala, Florida, United States
Urology Treatment Center, Sarasota, Florida, United States
Georgia Urology, Atlanta, Georgia, United States
Affliated Urology, Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Evanston Northwestern Healthcare, Evanston, Illinois, United States
Clinic of Urologic Wellness, Lexington, Kentucky, United States
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, United States
Cambridge Urological Associates, Inc., Cambridge, Massachusetts, United States
Michigan Institute of Urology, Detroit, Michigan, United States
Mississippi Urology Clinic, P.A., Jackson, Mississippi, United States
Urology Center, Omaha, Nebraska, United States
Sheldon Freedman Ltd., Las Vegas, Nevada, United States
Desert Urology, North Las Vegas, Nevada, United States
Norris Cotton Cancer Center, Lebanon, New Hampshire, United States
Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, United States
Office of John Byrne, New Rochelle, New York, United States
Mount Sinai Medical Center, NY, New York, New York, United States
Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Wake Urological Associates, Raleigh, North Carolina, United States
Department of Urology and Urologic Oncology, Columbus, Ohio, United States
Oregon Cancer Center at Oregon Health Sciences University, Portland, Oregon, United States
Urology Clinic, P.C., Portland, Oregon, United States
Office of Jeffrey K. Cohen, Pittsburgh, Pennsylvania, United States
Veterans Affairs Medical Center - Memphis, Memphis, Tennessee, United States
Vanderbilt Cancer Center, Nashville, Tennessee, United States
Urology Associates of North Texas, Arlington, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
Wilford Hall - 59th Medical Wing, Lackland Air Force Base, Texas, United States
Veterans Affairs Medical Center - Temple, Temple, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Sentara Cancer Center, Norfolk, Virginia, United States
Virginia Urology Center, Richmond, Virginia, United States
Office of Ronald G. Anderson, Tacoma, Washington, United States
West Virginia University Hospitals, Morgantown, West Virginia, United States
Ottawa General Hospital, Ottawa, Ontario, Canada
Toronto General Hospital, Toronto, Ontario, Canada
Contact Details
Name: Peter R. Carroll, MD
Affiliation: University of California, San Francisco
Role: STUDY_CHAIR
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