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RECRUITING
NCT05124951
PHASE2

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

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

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

Official title: The Efficacy of Whole-ventricle Irradiation Plus Primary Boost in Patients With Localized Basal Ganglia Germ Cell Tumors: Prospective Phase II Study

Key Details

Gender

All

Age Range

3 Years - 30 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2021-09-15

Completion Date

2026-10-31

Last Updated

2021-11-18

Healthy Volunteers

No

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.

Locations (1)

Beijing Tiantan Hospital

Beijing, China