Surgery With or Without Chemotherapy in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer
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
2 other identifiers
interventional
300
2 countries
53
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1996
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
July 22, 2004
CompletedNovember 6, 2013
May 1, 2007
November 1, 1999
November 5, 2013
Conditions
Keywords
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (53)
Urology Associates
Birmingham, Alabama, 35205, United States
Urology Associates, Ltd.
Phoenix, Arizona, 85012, United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658, United States
San Diego Urology Center
La Mesa, California, 91942, United States
Hillcrest Urological Medical Group
San Diego, California, 92103, United States
San Diego Urology Center
San Diego, California, 92120, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128, United States
Santa Monica Urologic Medical Group
Santa Monica, California, 90404, United States
Western Urological Associates
Van Nuys, California, 91405, United States
Urology Specialists, P.C.
Waterbury, Connecticut, 06708, United States
George Washington University Hospital
Washington D.C., District of Columbia, 20037, United States
Atlantic Urological Associates
Daytona Beach, Florida, 32114, United States
University of Florida - Gainesville
Gainesville, Florida, 32610-0277, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136, United States
Urology Care - South
Miami, Florida, 33173, United States
Urology Health Center
New Port Richey, Florida, 34652, United States
Office of Ira W. Klimberg
Ocala, Florida, 32674, United States
Urology Treatment Center
Sarasota, Florida, 3429, United States
Georgia Urology
Atlanta, Georgia, 30342, United States
Affliated Urology
Chicago, Illinois, 60612, United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637, United States
Evanston Northwestern Healthcare
Evanston, Illinois, 60201, United States
Clinic of Urologic Wellness
Lexington, Kentucky, 40509, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932, United States
Cambridge Urological Associates, Inc.
Cambridge, Massachusetts, 02238, United States
Michigan Institute of Urology
Detroit, Michigan, 48236, United States
Mississippi Urology Clinic, P.A.
Jackson, Mississippi, 39202, United States
Urology Center
Omaha, Nebraska, 68122, United States
Sheldon Freedman Ltd.
Las Vegas, Nevada, 89109, United States
Desert Urology
North Las Vegas, Nevada, 89128, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756, United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095, United States
Office of John Byrne
New Rochelle, New York, 10801, United States
Mount Sinai Medical Center, NY
New York, New York, 10029, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Wake Urological Associates
Raleigh, North Carolina, 27607, United States
Department of Urology and Urologic Oncology
Columbus, Ohio, 43210, United States
Oregon Cancer Center at Oregon Health Sciences University
Portland, Oregon, 97201-3098, United States
Urology Clinic, P.C.
Portland, Oregon, 97210, United States
Office of Jeffrey K. Cohen
Pittsburgh, Pennsylvania, 15222, United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104, United States
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838, United States
Urology Associates of North Texas
Arlington, Texas, 76015, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Wilford Hall - 59th Medical Wing
Lackland Air Force Base, Texas, 78236-5300, United States
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84132, United States
Sentara Cancer Center
Norfolk, Virginia, 23507, United States
Virginia Urology Center
Richmond, Virginia, 23230, United States
Office of Ronald G. Anderson
Tacoma, Washington, 98405, United States
West Virginia University Hospitals
Morgantown, West Virginia, 26506-9162, United States
Ottawa General Hospital
Ottawa, Ontario, K1H 8L6, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Peter R. Carroll, MD
University of California, San Francisco