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
Beijing Tiantan Hospital
150 participants
Sep 15, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria17
- Stratum I: germinoma
- 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
- 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 Criteria17
- 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
- Bilateral basal ganglia/ thalamus lesions
- Synchronous pineal or sellar/suprasellar lesion
- Diabetes insipitus
- With extracranial lesion(s)
- IU/L<serum/CSF β-HCG <500IU/L without histology
- Mature teratoma with normal AFP and β-HCG <500IU/L
- Inadequate organ function
- Poor compliance
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Whole-ventricle irradiation will be applied in patients with localized basal ganglia germ cell tumors after induction chemotherapy
Carboplatin/etoposide regimen is applied as induction chemotherapy in patients with basal ganglia germinoma
Ifosfamide/cisplatin/etoposide regimen is applied as induction chemotherapy in patients with basal ganglia non-germinomatous germ cell tumors.
Second-look surgery would be applied to patients who presented residue disease after induction chemotherapy.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05124951