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

  • STATUS
    Recruiting
  • End date
    Oct 31, 2026
  • participants needed
    150
  • sponsor
    Beijing Tiantan Hospital
Updated on 25 November 2021

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

Description

Intracranial germ cell tumors originating from the basal ganglia area are rare, accounting for less than 20% of patients. Radiotherapy played a vital role in the treatment of this malignancy. However, the optimal target volume is still undetermined.

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.

Details
Condition Intracranial Germ Cell CNS Tumor, Childhood
Treatment Second-Look Surgery, Whole-ventricle irradiation, Carboplatin/etoposide, Carboplatin/etoposide, Ifosfamide/cisplatin/etoposide
Clinical Study IdentifierNCT05124951
SponsorBeijing Tiantan Hospital
Last Modified on25 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

years age 30 years
Newly diagnosed
Unilateral basal ganglia/thalamus lesion
NGGCTs: Histologically confirmed; and/or serum and/or CSF AFP elevation; beta-HCG500IU/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)
IU/L<serum/CSF -HCG <500IU/L without histology
Mature teratoma with normal AFP and -HCG <500IU/L
Inadequate organ function
Poor compliance
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