The Efficacy of WVI in Patients With Localized Basal Ganglia Intracranial Germ Cell Tumors
NCT ID: NCT05124951
Last Updated: 2021-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2021-09-15
2026-10-31
Brief Summary
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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
Detailed Description
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Our study regarding relapse patterns of different radiation volumes showed that the ventricular system and ipsilateral frontal lobe were at risk of relapse after focal radiotherapy. Although craniospinal irradiation (CSI) and whole-brain irradiation (WBI) could significantly reduce the relapse in the above areas, the adverse effect on the quality of life is still a concern. As a result, the investigators proposed whole-ventricular irradiation (WVI) in patients with localized basal ganglia germ cell tumors. In order to evaluate its efficacy and safety, the investigators designed this phase II study.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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iGCTS
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.
Whole-ventricle irradiation
Whole-ventricle irradiation will be applied in patients with localized basal ganglia germ cell tumors after induction chemotherapy
Carboplatin/etoposide
Carboplatin/etoposide regimen is applied as induction chemotherapy in patients with basal ganglia germinoma
Ifosfamide/cisplatin/etoposide
Ifosfamide/cisplatin/etoposide regimen is applied as induction chemotherapy in patients with basal ganglia non-germinomatous germ cell tumors.
Second-look surgery
Second-look surgery would be applied to patients who presented residue disease after induction chemotherapy.
Interventions
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Whole-ventricle irradiation
Whole-ventricle irradiation will be applied in patients with localized basal ganglia germ cell tumors after induction chemotherapy
Carboplatin/etoposide
Carboplatin/etoposide regimen is applied as induction chemotherapy in patients with basal ganglia germinoma
Ifosfamide/cisplatin/etoposide
Ifosfamide/cisplatin/etoposide regimen is applied as induction chemotherapy in patients with basal ganglia non-germinomatous germ cell tumors.
Second-look surgery
Second-look surgery would be applied to patients who presented residue disease after induction chemotherapy.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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)
* 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
3 Years
30 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Responsible Party
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Tao Jiang
Principal investigator
Principal Investigators
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Tao Jiang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Locations
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Beijing Tiantan Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Bo Li, MD,PhD
Role: primary
Other Identifiers
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CHN-IGCT-001
Identifier Type: -
Identifier Source: org_study_id