Whole-ventricle irradiation for localized basal ganglia 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
This study is testing a type of radiation treatment for young people with localized brain tumors to see if it helps them live longer and feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 3 Years to 30 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05124951 on ClinicalTrials.gov |
What this trial studies
This phase II study evaluates the efficacy and safety of whole-ventricle irradiation (WVI) in patients aged 3 to 30 years with localized basal ganglia germ cell tumors. The primary endpoints include three-year disease-free survival and overall survival rates, alongside assessments of health-related quality of life using standardized questionnaires. The study also aims to identify adverse effects of chemoradiotherapy. By focusing on a specific radiation approach, the study seeks to optimize treatment while minimizing negative impacts on patients' quality of life.
Who should consider this trial
Good fit: Ideal candidates are children and young adults aged 3 to 30 years with newly diagnosed unilateral basal ganglia or thalamus germ cell tumors.
Not a fit: Patients with bilateral lesions, synchronous tumors, or those with inadequate organ function may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and quality of life for patients with localized basal ganglia germ cell tumors.
How similar studies have performed: While there have been studies on craniospinal and whole-brain irradiation, the specific approach of whole-ventricle irradiation in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing
- Beijing Tiantan Hospital — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Tao Jiang, MD, PhD — Beijing Tiantan Hospital
- Study coordinator: Bo Li, MD,PhD
- Email: libo@bjtth.org
- Phone: (86)10-59975581
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.