Идёт набор NCT05124951

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

Фаза II С лечением Intracranial Germ Cell CNS Tumor, Childhood

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Whole-ventricle irradiation, Carboplatin/etoposide, Ifosfamide/cisplatin/etoposide, Second-look surgery.
Кому может быть актуально: Состояния в реестре: Intracranial Germ Cell CNS Tumor, Childhood. Базовые параметры: 3 лет — 30 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Efficacy of Whole-ventricle Irradiation Plus Primary Boost in Patients With Localized Basal Ganglia Germ Cell Tumors: Prospective Phase II Study

Обзор

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

Подробное описание

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.

Вмешательства

Лучевая терапия Whole-ventricle irradiation
Whole-ventricle irradiation will be applied in patients with localized basal ganglia germ cell tumors after induction chemotherapy
Препарат Carboplatin/etoposide
Carboplatin/etoposide regimen is applied as induction chemotherapy in patients with basal ganglia germinoma
Препарат Ifosfamide/cisplatin/etoposide
Ifosfamide/cisplatin/etoposide regimen is applied as induction chemotherapy in patients with basal ganglia non-germinomatous germ cell tumors.
Процедура Second-look surgery
Second-look surgery would be applied to patients who presented residue disease after induction chemotherapy.

Первичные конечные точки

3-year event-free survival [Срок оценки: 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.]
Change of score of the QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales, Chinese edition) [Срок оценки: Score will be obtained at baseline, 6 months posttreatment, yearly through 3 years posttreatment]
Change of score of the QoL questionnaire (Short form-36) [Срок оценки: Evaluation will be conducted at baseline, 6 months posttreatment, yearly through 3 years posttreatment]
Change of score of Chinese Wechsler Intelligence Scale for Children [Срок оценки: Score will be obtained at baseline, 6 months posttreatment, yearly through 3 years posttreatment]

Вторичные конечные точки (2)

3-year overall survival [Срок оценки: 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.]
Short-term adverse effects of treatments [Срок оценки: From the beginning to the completion of chemoradiotherapy, approximately 6 months. Grade 3/4 toxicities will be documented]

Критерии участия

Stratum I: germinoma

Критерии включения

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

Критерии исключения

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

Критерии включения

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