Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT05455918
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
1 Year
Maximum Age:
20 Years
Study:
NCT05455918
Study Brief:
Protocol Section:
NCT05455918