|

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

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

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.