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

Last updated: November 7, 2021
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Testicular Cancer

Treatment

N/A

Clinical Study ID

NCT05124951
CHN-IGCT-001
  • Ages 3-30
  • All Genders

Study 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 Criteria

Inclusion

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

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

Study Design

Total Participants: 150
Study Start date:
September 15, 2021
Estimated Completion Date:
October 31, 2026

Study 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.

Connect with a study center

  • Beijing Tiantan Hospital

    Beijing, 100070
    China

    Active - Recruiting

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