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Surgery With or Without Chemotherapy in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer

2014-08-27 03:58:33 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Conditions

Bladder Cancer

Intervention

valrubicin, conventional surgery

Location

Urology Associates
Birmingham
Alabama
United States
35205

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:58:33-0400

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PubMed Articles [26085 Associated PubMed Articles listed on BioPortfolio]

Cohort profile: The Swedish National Register of Urinary Bladder Cancer (SNRUBC) and the Bladder Cancer Data Base Sweden (BladderBaSe).

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Increased Accuracy of a novel mRNA-based Urine Test for Bladder Cancer Surveillance.

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Hyaluronic acid family in bladder cancer: potential prognostic biomarkers and therapeutic targets.

Molecular markers of clinical outcome may aid in designing targeted treatments for bladder cancer. However, only a few bladder cancer biomarkers have been examined as therapeutic targets.

Review of the Clinical Approaches to the Use of Urine-based Tumor Markers in Bladder Cancer.

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Fangchinoline Induces Apoptosis, Autophagy and Energetic Impairment in Bladder Cancer.

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Medical and Biotech [MESH] Definitions

Tumors or cancer of the URINARY BLADDER.

A HERNIA-like condition in which the weakened pelvic muscles cause the URINARY BLADDER to drop from its normal position. Fallen urinary bladder is more common in females with the bladder dropping into the VAGINA and less common in males with the bladder dropping into the SCROTUM.

Endoscopic examination, therapy or surgery of the urinary bladder.

That portion of the stomach remaining after gastric surgery, usually gastrectomy or gastroenterostomy for cancer of the stomach or peptic ulcer. It is a common site of cancer referred to as stump cancer or carcinoma of the gastric stump.

Involuntary discharge of URINE as a result of physical activities that increase abdominal pressure on the URINARY BLADDER without detrusor contraction or overdistended bladder. The subtypes are classified by the degree of leakage, descent and opening of the bladder neck and URETHRA without bladder contraction, and sphincter deficiency.

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