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

NCT05455918 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-07-13

No results posted yet for this study

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.

Conditions

  • Pediatric Germ Cell Tumor

Interventions

DRUG

TIP treatment (paclitaxel/ifosfamide/cisplatin)

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)

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Jung Woo Han · Department of Pediatric Hematology and Oncology, Yonsei Cancer Center, Yonsei University Health System.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
20 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-26
Primary Completion
2025-06-30
Completion
2028-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05455918 on ClinicalTrials.gov