RecruitingPhase 2

The Efficacy of WVI in Patients With Localized Basal Ganglia Intracranial Germ Cell Tumors

China150 participantsStarted 2021-09-15

Plain-language 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

Who can participate

Age range

3 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Change of score of the QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales, Chinese edition)

Timeframe: Score will be obtained at baseline, 6 months posttreatment, yearly through 3 years posttreatment

Change of score of the QoL questionnaire (Short form-36)

Timeframe: Evaluation will be conducted at baseline, 6 months posttreatment, yearly through 3 years posttreatment

Change of score of Chinese Wechsler Intelligence Scale for Children

Timeframe: Score will be obtained at baseline, 6 months posttreatment, yearly through 3 years posttreatment

Trial details

NCT IDNCT05124951

SponsorBeijing Tiantan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-31

Contact for this trial

Bo Li, MD,PhD

(86)10-59975581 libo@bjtth.org

View on ClinicalTrials.gov More Intracranial Germ Cell CNS Tumor, Childhood trials

Plain-language summary

Who can participate

Age range

3 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

3-year event-free survival

Change of score of the QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales, Chinese edition)

Timeframe: Score will be obtained at baseline, 6 months posttreatment, yearly through 3 years posttreatment

Change of score of the QoL questionnaire (Short form-36)

Timeframe: Evaluation will be conducted at baseline, 6 months posttreatment, yearly through 3 years posttreatment

Change of score of Chinese Wechsler Intelligence Scale for Children

Timeframe: Score will be obtained at baseline, 6 months posttreatment, yearly through 3 years posttreatment