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

Capital Medical University

Status and phase: Enrolling; Phase 2

Conditions: Intracranial Germ Cell CNS Tumor, Childhood

Treatments: Drug: Ifosfamide/cisplatin/etoposide; Drug: Carboplatin/etoposide; Radiation: Whole-ventricle irradiation; Procedure: Second-look surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05124951

CHN-IGCT-001

Details and patient eligibility

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 3 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

iGCTS

Experimental group

Description:

Stratum I (Germinoma) Patients who achieved complete response after induction chemotherapy will receive WVI 2400cGy/15f plus primary boost 640cGy/4f. Stratum II (NGGCTs) At the time of response evaluation before radiotherapy, those with complete response or residue disease \<1.5cm will receive WVI 3060cGy/17f plus primary boost 2340cGy/13f.

Treatment:

Procedure: Second-look surgery

Drug: Carboplatin/etoposide

Radiation: Whole-ventricle irradiation

Drug: Ifosfamide/cisplatin/etoposide