NCT05455918 Paclitaxel/Ifosfamide/Cisplatin Chemotherapy for High Risk Pediatric Germ Cell Tumor
| NCT ID | NCT05455918 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Yonsei University |
| Condition | Pediatric Germ Cell Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2020-07-26 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 42 participants in total. It began in 2020-07-26 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Jung Woo Han
PRINCIPAL INVESTIGATOR
Department of Pediatric Hematology and Oncology, Yonsei Cancer Center, Yonsei University Health System.
Frequently Asked Questions
Who can join the NCT05455918 clinical trial?
This trial is open to male participants only, aged 1 Year or older, up to 20 Years, studying Pediatric Germ Cell Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05455918 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05455918 currently recruiting?
Yes, NCT05455918 is actively recruiting participants. Contact the research team at JWHAN@yuhs.ac for enrollment information.
Where is the NCT05455918 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05455918 clinical trial?
NCT05455918 is sponsored by Yonsei University. The principal investigator is Jung Woo Han at Department of Pediatric Hematology and Oncology, Yonsei Cancer Center, Yonsei University Health System.. The trial plans to enroll 42 participants.