EUCTR2016-000658-37-AT进行中（未招募）1 期
eoadjuvant chemotherapy with gemcitabine and cisplatin (GC) versus dose-dense methotrexate, vinblastine, doxorubicin and cisplatin (MVAC) in muscle-invasive urothelial carcinoma of the bladder
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 124
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •· Transitional cell carcinoma; may have papillary, squamous, or adenocarcinoma features provided the dominant histology is TCC. Small cell will not be permitted.
- •· Pathologic stage of T3, T4, or N+ without evidence of distant metastases
- •· Radical cystectomy/nephrectomy (for upper tract) within 90 days prior to
- •· ECOG performance status 0 or 1
- •· Adequate renal function, with serum creatinine < institutional ULN or
- •measured 24-hour creatinine clearance >50 mL/min
- •· Adequate hematopoietic function, with WBC >3.0, Hb >9, and platelets
- •>100,000.
- •· Adequate hepatic function, with bilirubin <1.5x ULN (except for patients with
- •Gilbert’s) and AST/ALT < 3 x ULN
- •· Normal LV EF and no unstable angina
- •· No prior systemic therapy for UC (intravesical therapy is permitted)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •please refer to Inclusion criteria
研究者
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