Clinical trial · Interventional
The Efficacy of WVI in Patients With Localized Basal Ganglia Intracranial Germ Cell Tumors
The Efficacy of Whole-ventricle Irradiation Plus Primary Boost in Patients With Localized Basal Ganglia Germ Cell Tumors: Prospective Phase II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intracranial Germ Cell CNS Tumor, Childhood | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin/etoposide | Drug | — | UNRESOLVED |
| Ifosfamide/cisplatin/etoposide | Drug | — | UNRESOLVED |
| Second-look surgery | Procedure | — | UNRESOLVED |
| Whole-ventricle irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- iGCTS
- description
- Stratum I (Germinoma) Patients who achieved complete response after induction chemotherapy will receive WVI 2400cGy/15f plus primary boost 640cGy/4f. Stratum II (NGGCTs) At the time of response evaluation before radiotherapy, those with complete response or residue disease \<1.5cm will receive WVI 3060cGy/17f plus primary boost 2340cGy/13f.
- interventionNames
- Radiation: Whole-ventricle irradiation
- Drug: Carboplatin/etoposide
- Drug: Ifosfamide/cisplatin/etoposide
- Procedure: Second-look surgery
Primary outcomes (4)
- measure
- 3-year event-free survival
- timeFrame
- From the enrollment to the event (relapse or death of any cause), approximately 3 years. The patients will receive long-term follow-up including MRI and serum tumor markers examination every 3 months until 36 months.
- description
- Event-free survival (DFS) is calculated from the date of enrollment to the date of an event (relapse or death of any cause).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 30 Years
Show eligibility criteria text
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
References
Publications (0)
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