Chemotherapy using Paclitaxel, Ifosfamide, and Cisplatin for high-risk pediatric germ cell tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of a chemotherapy regimen consisting of paclitaxel, ifosfamide, and cisplatin (TIP) as a first-line treatment for high-risk pediatric germ cell tumors. The study focuses on patients aged 1 to 20 years with untreated germ cell tumors that are classified as stage II or higher. The TIP regimen aims to improve survival rates while reducing lung toxicity compared to standard treatments. The trial will assess the outcomes of this approach in a population known to have poor prognoses.

Why it matters

Who can join: the full rules

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

  1. embryonal carcinoma
  2. choriocarcinoma
  3. yolk sac tumor
  4. teratoma with malignant germ cell tumor elements
* High risk definition

  1. More than 11 years old, male or female
  2. Less than 11 years old, male or female

     1. Extragonodal germ cell tumor, stage III
     2. Extragonodal germ cell tumor, stage IV
     3. 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

  1. Bone marrow : Absolute neutrophil count \>=1000/µL , platelet \>= 100000/µL
  2. Renal function : serum creatinine ≤ 1.5 x upper limit of normal (ULN)
  3. Hepatic function : total bilirubin ≤ 1.5 x ULN, ALT ≤ 3.0 x UNL
  4. Cardiac Function : Ejection fraction ≥ 50%
  5. Uncontrolled infection
  6. Uncontrolled urinary obstruction
  7. Uncontrolled cystitis
* Followings will be excluded

  1. Mature teratoma
  2. Gliomatosis Peritonei
  3. Low Risk Germ Cell Tumor
  4. testicular stage I
  5. ovarian stage I
  6. recurrent, refractory tumor
* Concomitant other trial agent beside the agents in this trial
* Concomitant chemotherapeutic agents besides the agents in this trial

  1. Concomitant tumor other than germ cell tumor
  2. Other trial agents
  3. Other chemotherapeutic agents

Where it's running

• Yonsei University Health System, Severance Hospital
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Jung Woo Han — Department of Pediatric Hematology and Oncology, Yonsei Cancer Center, Yonsei University Health System.
• Study coordinator: Jung Woo Han
• Email: JWHAN@yuhs.ac
• Phone: 82-2-2228-2050

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.