The Efficacy of WVI in Patients With Localized Basal Ganglia Intracranial Germ Cell Tumors
Sponsored by Beijing Tiantan Hospital
About this trial
Last updated 4 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started 4 years ago
What is this trial about?
What are the Participation Requirements?
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