Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT05124951
Brief 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
Detailed 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.
Study:
NCT05124951
Study Brief:
Protocol Section:
NCT05124951