drugset / Trial / NCT05455918

Paclitaxel/Ifosfamide/Cisplatin Chemotherapy for High Risk Pediatric Germ Cell Tumor

NCT05455918 ↗

Phase 2 Recruiting 42 enrolled Yonsei University
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2020-07-26
Primary completion
2025-06
Completion
2028-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 25 mg/m2 —
Subject Ifosfamide Small molecule 1500 mg/m2 —
Subject Paclitaxel Small molecule 240 mg/m2 —