Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin Un-fit Advanced Urothelial Carcinoma: Randomized Phase II Study
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- Response rate
研究概览
简要总结
Cisplatin-based chemotherapy is the standard regimen for advanced urothelial carcinoma.
But cisplatin-unfit patients account for up to 30-40% of patients in clinical practice.
Recently reported phase II/III trial of EORTC 30986 comparing gemcitabine/carboplatin (GCb) with MCAVI (Methotrexate, Carboplatin, Vinblastine) suggested that GCb be the preferred regimen over MCAVI based on the response rates, adverse events, and severe acute toxicities.
But the grade 3 or worse toxicities associated with GCb are not infrequent and need more effective and more tolerable regimens.
GemOx has been reported to be effective and have very favorable toxicity profiles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cytologically of histologically confirmed urothelial carcinoma
- •Locally advanced or metastatic disease
- •Measurable disease according to RECIST v.1.1
- •ECOG PS 0-2
- •Cisplatin-unfit condition (any of the followings: NYHA functional class 3, creatinine clearance 30-60 ml/min, and ECOG PS=2)
- •Adequate organ function
- •Chemotherapy-naive
排除标准
- •Histology other than urothelial carcinoma, but squamous cell carcinoma or adenocarcinoma mixed with urothelial carcinoma are allowed
- •CNS metastases
- •Peripheral neuropathy grade 2 or worse
- •Serious medical or surgical conditions
研究组 & 干预措施
GCb
Gemcitabine plus Carboplatin
干预措施: GCb (Drug)
GemOx
Gemcitabine plus Oxaliplatin
干预措施: GemOx (Drug)
结局指标
主要结局
Response rate
时间窗: 12 weeks
Response rate based on RECIST 1.1
次要结局
- Safety(12 months)
- Progression-free survival(1 year)
- Overall survival(1 year)
研究者
JLee
Associate professor
Asan Medical Center