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Tests treatment safety and results for Intracranial Germ Cell CNS Tumor, Childhood
Official title The Efficacy of WVI in Patients With Localized Basal Ganglia Intracranial Germ Cell Tumors
ClinicalTrials.gov ID: NCT05124951
What this study is testing
What is Carboplatin/etoposide?
Carboplatin/etoposide is an investigational medicine, being studied as a potential treatment for intracranial germ cell cns tumor, childhood.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Primary endpoint 1. three-year disease-free survival of patients with localized basal ganglia germ cell tumors receiving whole-ventricle irradiation 2.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 30
You may be able to join if
- Stratum I: germinoma
- 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
You likely can't join 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
See the full eligibility criteria
- Stratum I: germinoma
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.