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The Efficacy of WVI in Patients With Localized Basal Ganglia Intracranial Germ Cell Tumors
RECRUITINGPhase 2Sponsored by Beijing Tiantan Hospital
Actively Recruiting
PhasePhase 2
SponsorBeijing Tiantan Hospital
Started2021-09-15
Est. completion2026-10-31
Eligibility
Age3 Years – 30 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05124951
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
Eligibility
Age: 3 Years – 30 YearsHealthy volunteers accepted
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\<serum/CSF β-HCG \<500IU/L without histology * Mature teratoma with normal AFP and β-HCG \<500IU/L * Inadequate organ function * Poor compliance
Conditions2
CancerIntracranial Germ Cell CNS Tumor, Childhood
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Actively Recruiting
PhasePhase 2
SponsorBeijing Tiantan Hospital
Started2021-09-15
Est. completion2026-10-31
Eligibility
Age3 Years – 30 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05124951