Actively Recruiting
Paclitaxel/Ifosfamide/Cisplatin Chemotherapy for High Risk Pediatric Germ Cell Tumor
Led by Yonsei University · Updated on 2022-07-13
42
Participants Needed
1
Research Sites
409 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Paclitaxel/Ifosfamide/Cisplatin Chemotherapy for High Risk Pediatric Germ Cell Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 1 year old and less than 20 years old
- Pathologically or cytologically diagnosed germ cell tumor
- Germ cell tumor not previously treated
- Germ cell tumor stage higher than II (stage I excluded)
- Pathologic types: embryonal carcinoma, choriocarcinoma, yolk sac tumor, or teratoma with malignant germ cell tumor elements
- High risk defined as either: 1) More than 11 years old, male or female; or 2) Less than 11 years old with extragonadal germ cell tumor stage III or IV, or ovarian germ cell tumor stage IV
- More than 8 weeks of life expectancy
- ECOG Performance score 0, 1, or 2
- Informed consent obtained
You will not qualify if you...
- Pregnancy or lactating (fertile men or women must agree to avoid pregnancy during the trial)
- Allergy or hypersensitivity to trial chemotherapeutic agents
- Severe hypersensitivity to Cremophor R EL (polyoxyethylated castor oil)
- Bone marrow dysfunction: absolute neutrophil count <1000/µL or platelets <100000/µL
- Renal dysfunction: serum creatinine >1.5 times upper limit of normal
- Hepatic dysfunction: total bilirubin >1.5 times upper limit of normal or ALT >3.0 times upper limit
- Cardiac dysfunction: ejection fraction less than 50%
- Uncontrolled infection
- Uncontrolled urinary obstruction
- Uncontrolled cystitis
- Presence of mature teratoma or Gliomatosis Peritonei
- Low risk germ cell tumor
- Testicular stage I or ovarian stage I germ cell tumor
- Recurrent or refractory tumor
- Use of other trial agents or chemotherapeutic agents besides those in this trial
- Presence of other tumors besides germ cell tumor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Actively Recruiting
Research Team
J
Jung Woo Han
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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