NCT05455918RecruitingPhase 2
Paclitaxel/Ifosfamide/Cisplatin Chemotherapy for High Risk Pediatric Germ Cell Tumor
Non-randomized, Phase II, Open-label Study for Efficacy and Safety of Consolidation Paclitaxel/Ifosfamide/Cisplatin (TIP) Chemotherapy for High Risk Pediatric Germ Cell Tumor
Source: ClinicalTrials.gov · Last updated 13 Jul 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 8 Jul 2022
- Start date
- 26 Jul 2020
- Primary completion date
- Jun 2025
- Lead sponsor
- Yonsei University
- Diseases
- Childhood cancers
- NCT number
- NCT05455918
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 42
- From 26 Jul 2020 to the primary completion date, Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previously reported allergy or hypersensitivity to trial chemotherapeutic agent
- 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
Other illness
- severe hypersensitivity to the agent containing Cremophor R EL (polyoxyethylated castor oil)
Lab values
- 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
Other
- pregnancy or lactating patients (fertile men or women should agree to avoid pregnancy during the trial period)
- Followings will be excluded
- Mature teratoma
- Gliomatosis Peritonei
- Low Risk Germ Cell Tumor
- testicular stage I
- ovarian stage I
- recurrent, refractory tumor
Who the study is looking for
- 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
- choriocarcinoma
- 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
Age in the registry: 1 year to 20 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yonsei University Health System, Severance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.