NCT00080795已完成2 期
Phase II Trial of Neoadjuvant, Multi-Agent Chemotherapy For Locally Advanced Urothelial Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as ifosfamide, doxorubicin, gemcitabine, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them before surgery, may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well neoadjuvant combination chemotherapy works in treating patients undergoing radical cystectomy for locally advanced carcinoma of the urothelium.
详细描述
OBJECTIVES:
Primary
- Determine the response rate and 4-year disease-free survival of patients with locally advanced carcinoma of the urothelium undergoing radical cystectomy treated with neoadjuvant chemotherapy comprising ifosfamide, doxorubicin, and gemcitabine followed by cisplatin, gemcitabine, and ifosfamide.
Secondary
- Compare perioperative morbidity and mortality of patients treated with this regimen vs historical standards.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed carcinoma of the urothelium, meeting 1 of the following criteria for locally advanced disease:
- •Clinical stage T3b disease, defined by presence of a mass on examination under anesthesia
- •Clinical stage T4a disease, defined by direct invasion of prostatic stroma, vagina, or rectum
- •Lymphovascular invasion on transurethral resection specimen
- •Upper tract disease or micropapillary histology allowed
- •No evidence of disease outside the pelvis
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Bone marrow function adequate
- •Liver function adequate
- •Creatinine clearance ≥ 45 mL/min
- •Cardiovascular
- •Ejection fraction ≥ 50%
- •Not pregnant
- •No other malignancy likely to be life-threatening within the next 4 years
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Response rate
时间窗: 6 weeks following treatment
Disease-free survival at 4 years
时间窗: 4 years
次要结局
- Comparison of perioperative treatment morbidity and mortality with historical standards(Minimally reviewed following 6 weeks post treatment)
研究者
研究点 (2)
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