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The Efficacy of WVI in Patients With Localized Basal Ganglia Intracranial Germ Cell Tumors

NCT05124951 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-11-18

No results posted yet for this study

Summary

Primary endpoint

1. three-year disease-free survival of patients with localized basal ganglia germ cell tumors receiving whole-ventricle irradiation
2. Health-related quality of life measured by PedsQL 4.0 and SF-36

Second endpoint

1. three-year overall survival of patients with localized basal ganglia germ cell tumors receiving whole-ventricle irradiation
2. Adverse effects of chemoradiotherapy measured by NCI CTCAE 5.0

Conditions

  • Intracranial Germ Cell CNS Tumor, Childhood

Interventions

RADIATION

Whole-ventricle irradiation

Whole-ventricle irradiation will be applied in patients with localized basal ganglia germ cell tumors after induction chemotherapy

DRUG

Carboplatin/etoposide

Carboplatin/etoposide regimen is applied as induction chemotherapy in patients with basal ganglia germinoma

DRUG

Ifosfamide/cisplatin/etoposide

Ifosfamide/cisplatin/etoposide regimen is applied as induction chemotherapy in patients with basal ganglia non-germinomatous germ cell tumors.

PROCEDURE

Second-look surgery

Second-look surgery would be applied to patients who presented residue disease after induction chemotherapy.

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Tao Jiang, MD, PhD · Beijing Tiantan Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • China

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 NCT05124951 on ClinicalTrials.gov