Phase II, open-label study for efficacy and safety of consolidation paclitaxel/ifosfamide/cisplatin (TIP) 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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0005355

Enrollment

Registered

2020-08-26

Start date

2024-07-29

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : The treatment for high risk germ cell tumor as primary treatment is as follows

? Paclitaxel 240mg/m2/day D1 (total 240mg/m2) ? Ifosfamide 1.5g/m2/day D2~5 (total 6g/m2) ? Cisplatin 25mg/m2/day D2~5 (total 100mg/m2)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 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 2 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 3 More than 8 weeks of life expectancy???? 8? ?? 4 performance level : ECOG Performance score 0, 1, or 2 5 informed consent should be obtained

Exclusion criteria

Exclusion criteria: 1 pregnancy or lactating patients (fertile men or women should agree to avoid pregnancy during the trial period) 2 previously reported allergy or hypersensitivity to trial chemotherapeutic agent 3 severe hypersensitivity to the agent containing Cremophor R EL (polyoxyethylated castor oil) 4 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 5 Followings will be excluded ?) Mature teratoma ?) Gliomatosis Peritonei ?) Low Risk Germ Cell Tumor ?) testicular stage I ?) ovarian stage I ?) recurrent, refractory tumor 6 Concomitant other trial agent beside the agents in this trial 7 Concomitant chemotherapeutic agents besides the agents in this trial ?) Concomitant tumor other than germ cell tumor ?) Other trial agents ?) Other chemotherapeutic agents

Design outcomes

Primary

Measure	Time frame
complete response rate	—

Secondary

Measure	Time frame
Overall Response Rate, ORR;Overall survival, OS;Event Free Survival, EFS;Safety analysis;complete response rate;Overall Response Rate, ORR	—

Countries

Korea, Republic of

Contacts

Public ContactYun-Jung Go

The Korean Society of Pediatric Hematology-Oncology

yjgo@kphog.or.kr+82-2-2228-2050

Outcome results