Intracranial Germ Cell CNS Tumor, Childhood
Conditions
Keywords
intracranial germ cell tumors, basal ganglia, radiotherapy, target volume, quality of life
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.
Interventions
RADIATIONWhole-ventricle irradiation
Whole-ventricle irradiation will be applied in patients with localized basal ganglia germ cell tumors after induction chemotherapy
Carboplatin/etoposide regimen is applied as induction chemotherapy in patients with basal ganglia germinoma
DRUGIfosfamide/cisplatin/etoposide
Ifosfamide/cisplatin/etoposide regimen is applied as induction chemotherapy in patients with basal ganglia non-germinomatous germ cell tumors.
PROCEDURESecond-look surgery
Second-look surgery would be applied to patients who presented residue disease after induction chemotherapy.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 30 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year event-free survival | 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. | Event-free survival (DFS) is calculated from the date of enrollment to the date of an event (relapse or death of any cause). |
| Change of score of the QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales, Chinese edition) | Score will be obtained at baseline, 6 months posttreatment, yearly through 3 years posttreatment | The PedsQL 4.0 Generic Core Scale contains 23 items that measures physical (eight items), emotional (five items), social (five items), and school (five items) functions. The Scale comprises parallel patient self-report and parent proxy-report formats. The items are reverse-scored and trans- formed to a 0-100 scale according to the instructions, and higher scores indicate a better HRQOL. (age ≤18 years) |
| Change of score of the QoL questionnaire (Short form-36) | Evaluation will be conducted at baseline, 6 months posttreatment, yearly through 3 years posttreatment | Altogether, 36 questions with standardized response choices were organized into eight scales, including physical functioning (PF), role limitations as a result of physical health problems (RP), body pain (BP), general health perceptions (GH), vitality (VT), social functioning (SF), role limitations as a result of emotional problems (RE), and general mental health (MH). Additionally, reported health transition (HT) was used to evaluate general health changes during the previous year. The raw scores were converted to a 0-100 scale according to the instructions, and higher scores indicated a better HRQOL. Physical component score (PCS) and mental component score (MCS) were also calculated. (Age \>15 years) |
| Change of score of Chinese Wechsler Intelligence Scale for Children | Score will be obtained at baseline, 6 months posttreatment, yearly through 3 years posttreatment | The intelligence of the child was tested by the China-Wechsler Intelligence Scale for Children (C-WISC), which was revised by Gong and Cai at Hunan Medical University. The C-WISC consists of 11 individual tests that include six verbal tests \[Information (I), Comprehend (C), Sorting (S), Arithmetic (A), Vocabulary (V), and Digit symbol (D)\] and five performance tests \[Picture Completing (PC), Picture Arrangement (PA), Block Pattern (BP), Object Assembly (OA), and Coding (CD)\]. Based on individual testing, vocabulary scores (V), procedure scores (P), and full scores (F) were obtained. Furthermore, the VIQ, PIQ, and full intelligence quotient (FIQ) were calculated progressively . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year overall survival | 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. | Overall survival is determined from the date of diagnosis to the date of death of any cause or the last follow-up visit |
| Short-term adverse effects of treatments | From the beginning to the completion of chemoradiotherapy, approximately 6 months. Grade 3/4 toxicities will be documented | NCI CTCAE 5.0 will be used for adverse effects evaluation |
Countries
China
Contacts
Primary ContactBo Li, MD,PhD
Outcome results
None listed