Actively Recruiting

Phase 2
Age: 3Years - 30Years
All Genders
NCT05124951

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

Led by Beijing Tiantan Hospital · Updated on 2021-11-18

150

Participants Needed

1

Research Sites

267 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 3Years - 30Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 3 and 30 years
  • Newly diagnosed unilateral basal ganglia or thalamus lesion
  • Histologically confirmed germinoma or non-germinomatous germ cell tumor; or elevated serum/CSF tumor markers as specified
  • No additional lesions in the central nervous system on imaging
  • Negative cerebrospinal fluid cytology test
  • Adequate organ function
  • Written informed consent provided
Not Eligible

You will not qualify if you...

  • Lesions in both basal ganglia or thalamus
  • Presence of synchronous pineal or sellar/suprasellar lesions
  • Diagnosis of diabetes insipidus
  • Presence of extracranial lesions
  • Serum or CSF beta-HCG levels greater than 50 IU/L without histological confirmation for germinoma
  • Serum or CSF beta-HCG levels between 50 IU/L and 500 IU/L without histological confirmation for non-germinomatous tumors
  • Mature teratoma with normal tumor markers
  • Inadequate organ function
  • Poor compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital

Beijing, China, 100070

Actively Recruiting

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Research Team

B

Bo Li, MD,PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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