NCT00818090终止2 期
A Phase II Study of Paclitaxel and Cisplatin in Previously Untreated, Unresectable Invasive Thymoma or Thymic Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
To assess the efficacy and safety of the regimen in previously untreated, unresectable invasive thymoma or thymic carcinoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •histologically or cytologically confirmed invasive thymoma or thymic carcinoma
- •unresectable tumor: by either local invasion, distant metastasis, or recurred (assessed by investigator)
- •no previous systemic treatment for invasive thymoma or thymic carcinoma
- •at least one measurable lesion by RECIST criteria
- •18 years old or older
- •ECOG performance status 0, 1, 2
- •adequate lab. findings neutrophil ≥ 1.5 x 10^9/L platelet ≥ 75 x 10^9/L hemoglobin ≥ 9.0 g/dL bilirubin ≤ 1.5 x upper normal limit AST, ALT ≤ 2.5 x upper normal limit Alkaline phosphatase ≤ 2.5 x upper normal limit (if liver metastasis, ≤ 5 x upper normal limit) serum creatinine ≤ 1.0 x upper normal limit if serum creatinine > 1.0 x upper normal limit, creatinine clearance ≥ 60 mL/min
- •patient who agree to written, informed consent
排除标准
- •other malignancy (exception: non-melanoma skin cancer, cervical carcinoma in situ, cancer without evidence more than 5 years since curative resection)
- •active bacterial infection
- •history of clinical trial with investigational drug within 30 days
- •radiotherapy to thoracic or mediastinal area (other area radiotherapy is permitted)
- •pregnant, or lactating women
- •patient with organ transplantation
- •peripheral neuropathy, grade 2 or greater
- •severe, medical condition unstable cardiac disease despite of adequate management myocardial infarction within 6 months active ulcer disease refractory to medication chronic obstructive lung disease requiring admission treatment within 1 year
- •uncontrolled seizure, cerebral nervous system disorder, psychiatric problem which decrease treatment compliance
研究组 & 干预措施
TP
Experimental
paclitaxel and cisplatin every 3 weeks
干预措施: paclitaxel and cisplatin (Drug)
结局指标
主要结局
Response rate
时间窗: 6 weeks, 12 weeks, 18 weeks
次要结局
- toxicity(start of medication to 4 weeks since the last medication)
- progression-free survival(till progression)
- duration of response(till progression)
- overall survival(till death, last follow-up)
研究者
Se-Hoon Lee
Korean Cancer Study Group
Korean Cancer Study Group
研究点 (1)
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