Clinical trial NCT05124951: The Efficacy of WVI in Patients With Localized Basal Ganglia Intracranial Germ Cell Tumors
Official title: The Efficacy of Whole-ventricle Irradiation Plus Primary Boost in Patients With Localized Basal Ganglia Germ Cell Tumors: Prospective Phase II Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Intracranial Germ Cell CNS Tumor, Childhood
Keywords: intracranial germ cell tumors
basal ganglia
radiotherapy
target volume
quality of life
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 150
Sex: ALL
Minimum age (years): 3
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 3-year event-free survival
timeFrame: From the enrollment to the event (relapse or death of any cause), approximately 3 years. The patients will receive long-term follow-up including MRI and serum tumor markers examination every 3 months until 36 months.
measure: Change of score of the QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales, Chinese edition)
timeFrame: Score will be obtained at baseline, 6 months posttreatment, yearly through 3 years posttreatment
measure: Change of score of the QoL questionnaire (Short form-36)
timeFrame: Evaluation will be conducted at baseline, 6 months posttreatment, yearly through 3 years posttreatment
measure: Change of score of Chinese Wechsler Intelligence Scale for Children
timeFrame: Score will be obtained at baseline, 6 months posttreatment, yearly through 3 years posttreatment
Secondary outcomes:
measure: 3-year overall survival
timeFrame: From the enrollment to the death of any cause or last follow-up, approximately 3 years.The patients will receive long-term follow-up including MRI and serum tumor markers examination every 3 months until 36 months.
measure: Short-term adverse effects of treatments
timeFrame: From the beginning to the completion of chemoradiotherapy, approximately 6 months. Grade 3/4 toxicities will be documented
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
affiliation: Beijing Tiantan Hospital
name: Tao Jiang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: