Non-randomized, Phase II, Open-label Study for Efficacy and Safety of Consolidation Paclitaxel/Ifosfamide/Cisplatin (TIP) Chemotherapy for High Risk Pediatric Germ Cell Tumor
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Complete Response Rate
研究概览
简要总结
Germ cell tumor has generally good prognosis, but high risk germ cell tumor has still very poor prognosis. There remains the need of further improvement with other chemotherapy strategy. Especially more than 11 years old, mediastinal germ cell tumor, stage 3 or 4 extragonodal germ cell tumor or the remained tumor after the primary treatment are the group with the poorest prognosis.
Paclitaxel is widely used chemotherapeutic agent in adults and the experience of the agent has also been accumulated in children. The paclitaxel, ifosfamide, cisplatin (TIP) regimen has been used 2nd-line treatment for germ cell tumor and there is some promising result of the role of TIP in first line germ cell tumor treatment. In high risk pediatric germ cell tumor patients, TIP regimen will be able to reduce lung toxicity from the bleomycin as the standard regimen and to improve the survival. In this trial, the efficacy and safety of TIP as the first line treatment for germ cell tumor will be elucidated.
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
- 1 Year 至 20 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Over 1 year old and less than 20 years old
- •Pathologically or cytologically diagnosed germ cell tumor
- •Germ cell tumor which has not been treated previously
- •Higher than stage II (stage I should be excluded)
- •Pathologic type
- •embryonal carcinoma
- •choriocarcinoma
- •yolk sac tumor
- •teratoma with malignant germ cell tumor elements
- •High risk definition
- •More than 11 years old, male or female
- •Less than 11 years old, male or female
- •Extragonodal germ cell tumor, stage III
- •Extragonodal germ cell tumor, stage IV
- •Ovarian germ cell tumor, stage IV
- •More than 8 weeks of life expectancy
- •performance level : ECOG Performance score 0, 1, or 2
- •informed consent should be obtained
排除标准
- •pregnancy or lactating patients (fertile men or women should agree to avoid pregnancy during the trial period)
- •previously reported allergy or hypersensitivity to trial chemotherapeutic agent
- •severe hypersensitivity to the agent containing Cremophor R EL (polyoxyethylated castor oil)
- •Acceptable organ functions
- •Bone marrow : Absolute neutrophil count >=1000/µL , platelet >= 100000/µL
- •Renal function : serum creatinine ≤ 1.5 x upper limit of normal (ULN)
- •Hepatic function : total bilirubin ≤ 1.5 x ULN, ALT ≤ 3.0 x UNL
- •Cardiac Function : Ejection fraction ≥ 50%
- •Uncontrolled infection
- •Uncontrolled urinary obstruction
- •Uncontrolled cystitis
- •Followings will be excluded
- •Mature teratoma
- •Gliomatosis Peritonei
- •Low Risk Germ Cell Tumor
- •testicular stage I
- •ovarian stage I
- •recurrent, refractory tumor
- •Concomitant other trial agent beside the agents in this trial
- •Concomitant chemotherapeutic agents besides the agents in this trial
- •Concomitant tumor other than germ cell tumor
- •Other trial agents
- •Other chemotherapeutic agents
研究组 & 干预措施
TIP treatment arm
干预措施: TIP treatment (paclitaxel/ifosfamide/cisplatin) (Drug)
结局指标
主要结局
Complete Response Rate
时间窗: 12weeks
次要结局
- Overall Response Rate(12 weeks and 18 weeks)
- Event Free Survival(3 years)
- Complete Response Rate(18 weeks)
- Overall Survival(3 years)