Paclitaxel/Ifosfamide/Cisplatin Chemotherapy for High Risk Pediatric Germ Cell Tumor

  • End date
    Jun 29, 2028
  • participants needed
  • sponsor
    Yonsei University
Updated on 4 October 2022


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.

Condition Pediatric Germ Cell Tumor
Treatment TIP treatment (paclitaxel/ifosfamide/cisplatin)
Clinical Study IdentifierNCT05455918
SponsorYonsei University
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

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
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

Exclusion Criteria

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
Clear my responses

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