The Efficacy of WVI in Patients With Localized Basal Ganglia Intracranial Germ Cell Tumors
Recruiting now · Phase 2
Conditions studied: Intracranial Germ Cell CNS Tumor, Childhood
In brief
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
Key facts
- Study ID
- NCT05124951
- Run by
- Beijing Tiantan Hospital
- People needed
- 150
- Starts
- 2021-09-15
- Expected to finish
- 2026-10-31
- Last updated by the study team
- 2021-11-18
Who can join
Age: 3 and older, up to 30. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Beijing Tiantan Hospital — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
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