Phase II, open-label study for efficacy and safety of consolidation paclitaxel/ifosfamide/cisplatin (TIP) chemotherapy for high risk pediatric germ cell tumor
- Conditions
- Neoplasms
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 42
1Over 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
2High 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
3More than 8 weeks of life expectancy???? 8? ??
4performance level : ECOG Performance score 0, 1, or 2
5informed consent should be obtained
1pregnancy or lactating patients (fertile men or women should agree to avoid pregnancy during the trial period)
2previously reported allergy or hypersensitivity to trial chemotherapeutic agent
3severe hypersensitivity to the agent containing Cremophor R EL (polyoxyethylated castor oil)
4Acceptable 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
5Followings will be excluded
?)Mature teratoma
?)Gliomatosis Peritonei
?)Low Risk Germ Cell Tumor
?)testicular stage I
?)ovarian stage I
?)recurrent, refractory tumor
6Concomitant other trial agent beside the agents in this trial
7Concomitant chemotherapeutic agents besides the agents in this trial
?)Concomitant tumor other than germ cell tumor
?)Other trial agents
?)Other chemotherapeutic agents
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method complete response rate
- Secondary Outcome Measures
Name Time Method Overall Response Rate, ORR;Overall survival, OS;Event Free Survival, EFS;Safety analysis