Surgery With or Without Chemotherapy in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer
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|ClinicalTrials.gov Identifier: NCT00003725|
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : July 22, 2004
Last Update Posted : November 6, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: valrubicin Procedure: conventional surgery||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|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 Start Date :||December 1996|
U.S. FDA Resources
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003725
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|Study Chair:||Peter R. Carroll, MD||University of California, San Francisco|