Surgery With or Without Chemotherapy in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer
- Conditions
- Bladder Cancer
- Registration Number
- NCT00003725
- Lead Sponsor
- Anthra Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (52)
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
🇺🇸San Diego, California, United States
Hillcrest Urological Medical Group
🇺🇸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
Scroll for more (42 remaining)Urology Associates🇺🇸Birmingham, Alabama, United States