NCT05124951

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 30 Years
• Healthy volunteers: Not accepted

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

Detailed description

Intracranial germ cell tumors originating from the basal ganglia area are rare, accounting for less than 20% of patients. Radiotherapy played a vital role in the treatment of this malignancy. However, the optimal target volume is still undetermined. Our study regarding relapse patterns of different radiation volumes showed that the ventricular system and ipsilateral frontal lobe were at risk of relapse after focal radiotherapy. Although craniospinal irradiation (CSI) and whole-brain irradiation (WBI) could significantly reduce the relapse in the above areas, the adverse effect on the quality of life is still a concern. As a result, the investigators proposed whole-ventricular irradiation (WVI) in patients with localized basal ganglia germ cell tumors. In order to evaluate its efficacy and safety, the investigators designed this phase II study.

Conditions

• Intracranial Germ Cell CNS Tumor, Childhood

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-09-15
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2021-11-18
• Last updated: 2021-11-18

Locations

1 site across 1 country: China