NCT02414685已完成2 期
A Treatment Strategy of the Use of 1st Line Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors Based on Tumor Marker Decline: A Phase II Trial of Paclitaxel, Ifosfamid and Cisplatin Regimen.
National Cancer Institute, Slovakia1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2015年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Complete response rate
研究概览
简要总结
TIP in the 1st line treatment of GCTs patients with unfavorable decline of serum tumor markers after 1 cycle of the BEP regimen.TIP will be administered to the patient until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.
详细描述
Cycle 1: BEP regimen
Serum tumor markers at day 18-21:
•Patients with an unfavorable pattern of tumor marker decrease after 1 cycle of BEP will receive 4 more cycles of TIP.
TIP regimen:
- Taxol 250 mg/ m2 iv on day 1
- Ifosfamid 1,2 g/ m2/ day iv x 5 days
- Cisplatin 20 mg/ m2/ day iv x 5 days One cycle of therapy consists of 22 days. Estimated duration of treatment: Until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients older than 16 years.
- •Evidence of NSGCT based on histologic examination or based on clinical evidence and high serum HCG or AFP levels (in case of clinical emergency, therapy can be started before pathologic sample is obtained if tumor markers are very elevated)
- •Testicular, retroperitoneal, or mediastinal primary site.
- •Evidence of disseminated disease (clinical stages II or III).
- •Disease classified as poor prognosis according to IGCCCG criteria:
- •Primary mediastinal NSGCT or
- •Non-pulmonary visceral metastases or
- •HCG > 50,000 UI/l, or AFP > 10,000 ng/ml, or LDH > 10 times the upper normal value.
- •No prior chemotherapy.
- •No previous carcinoma, except basal-cell carcinoma of the skin.
- •Adequate renal function: measured or calculated creatinine clearance> 60 ml/min.
- •Absolute granulocyte count >= 1,500/mm3, platelets >= 100,000 mm3, bilirubine <= 1.5 fold the upper normal value.
- •Unfavorable tumor marker decline after 1.cycle of BEP
- •Signed informed consent.
排除标准
- •Patients infected by the Human Immunodeficiency Virus (HIV).
- •Patients who do not fit inclusion criteria.
研究组 & 干预措施
intravenous chemotherapy
Experimental
TIP regimen:
- Paclitaxel 250 mg/ m2 iv on day 1
- Ifosfamide 1,2 g/ m2/ day iv x 5 days
- Cisplatin 20 mg/ m2/ day iv x 5 days
干预措施: Paclitaxel (Drug)
intravenous chemotherapy
Experimental
TIP regimen:
- Paclitaxel 250 mg/ m2 iv on day 1
- Ifosfamide 1,2 g/ m2/ day iv x 5 days
- Cisplatin 20 mg/ m2/ day iv x 5 days
干预措施: Ifosfamide (Drug)
intravenous chemotherapy
Experimental
TIP regimen:
- Paclitaxel 250 mg/ m2 iv on day 1
- Ifosfamide 1,2 g/ m2/ day iv x 5 days
- Cisplatin 20 mg/ m2/ day iv x 5 days
干预措施: Cisplatin (Drug)
结局指标
主要结局
Complete response rate
时间窗: 36 month
according RECIST criteria version 1.1
次要结局
- Response rate(36 month)
- Number of adverse events grade III and IV(36 month)
- overall survival(36 months)
- Progression-free survival(36 month)
研究者
研究点 (1)
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