Overview

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

Status:
Recruiting
Trial end date:
2026-10-31
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Beijing Tiantan Hospital
Treatments:
Carboplatin
Etoposide
Etoposide phosphate
Ifosfamide
Criteria
Stratum I: germinoma

Inclusion Criteria:

- 3 years ≤ age ≤ 30 years

- Newly diagnosed

- Unilateral basal ganglia/thalamus lesion

- Germinoma：Histologically confirmed; and/or serum and/or CSF beta-HCG elevation
(≤50IU/L); AFP negative

- No radiological evidence of additional lesions in the CNS

- Negative CSF cytology test

- Adequate organ function

- Written informed consent

Exclusion Criteria:

- Bilateral basal ganglia/ thalamus lesions

- Synchronous pineal or sellar/suprasellar lesion

- Diabetes insipidus

- With extracranial lesion(s)

- Serum/CSF β-HCG >50IU/L without histology

- Mature teratoma with normal tumor markers

- Inadequate organ function

- Poor compliance

Stratum II: non-germinomatous germ cell tumors

Inclusion Criteria:

- 3 years ≤ age ≤ 30 years

- Newly diagnosed

- Unilateral basal ganglia/thalamus lesion

- NGGCTs: Histologically confirmed; and/or serum and/or CSF AFP elevation;
beta-HCG≥500IU/L

- No radiological evidence of additional lesions in the CNS

- Negative CSF cytology test

- Adequate organ function

- Written informed consent

Exclusion Criteria:

- Bilateral basal ganglia/ thalamus lesions

- Synchronous pineal or sellar/suprasellar lesion

- Diabetes insipitus

- With extracranial lesion(s)

- 50IU/L
- Mature teratoma with normal AFP and β-HCG <500IU/L

- Inadequate organ function

- Poor compliance