The Efficacy of WVI in Patients With Localized Basal Ganglia Intracranial Germ Cell Tumors
Primary Purpose
Intracranial Germ Cell CNS Tumor, Childhood
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Whole-ventricle irradiation
Carboplatin/etoposide
Ifosfamide/cisplatin/etoposide
Second-look surgery
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Germ Cell CNS Tumor, Childhood focused on measuring intracranial germ cell tumors, basal ganglia, radiotherapy, target volume, quality of life
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
Sites / Locations
- Beijing Tiantan HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
iGCTS
Arm 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.
Outcomes
Primary Outcome Measures
3-year event-free survival
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)
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)
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
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 Outcome Measures
3-year overall survival
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
NCI CTCAE 5.0 will be used for adverse effects evaluation
Full Information
NCT ID
NCT05124951
First Posted
October 13, 2021
Last Updated
November 7, 2021
Sponsor
Beijing Tiantan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05124951
Brief Title
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
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
October 31, 2026 (Anticipated)
Study Completion Date
October 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Primary endpoint
three-year disease-free survival of patients with localized basal ganglia germ cell tumors receiving whole-ventricle irradiation
Health-related quality of life measured by PedsQL 4.0 and SF-36
Second endpoint
three-year overall survival of patients with localized basal ganglia germ cell tumors receiving whole-ventricle irradiation
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Germ Cell CNS Tumor, Childhood
Keywords
intracranial germ cell tumors, basal ganglia, radiotherapy, target volume, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
iGCTS
Arm Type
Experimental
Arm 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.
Intervention Type
Radiation
Intervention Name(s)
Whole-ventricle irradiation
Intervention Description
Whole-ventricle irradiation will be applied in patients with localized basal ganglia germ cell tumors after induction chemotherapy
Intervention Type
Drug
Intervention Name(s)
Carboplatin/etoposide
Intervention Description
Carboplatin/etoposide regimen is applied as induction chemotherapy in patients with basal ganglia germinoma
Intervention Type
Drug
Intervention Name(s)
Ifosfamide/cisplatin/etoposide
Intervention Description
Ifosfamide/cisplatin/etoposide regimen is applied as induction chemotherapy in patients with basal ganglia non-germinomatous germ cell tumors.
Intervention Type
Procedure
Intervention Name(s)
Second-look surgery
Intervention Description
Second-look surgery would be applied to patients who presented residue disease after induction chemotherapy.
Primary Outcome Measure Information:
Title
3-year event-free survival
Description
Event-free survival (DFS) is calculated from the date of enrollment to the date of an event (relapse or death of any cause).
Time Frame
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.
Title
Change of score of the QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales, Chinese edition)
Description
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)
Time Frame
Score will be obtained at baseline, 6 months posttreatment, yearly through 3 years posttreatment
Title
Change of score of the QoL questionnaire (Short form-36)
Description
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)
Time Frame
Evaluation will be conducted at baseline, 6 months posttreatment, yearly through 3 years posttreatment
Title
Change of score of Chinese Wechsler Intelligence Scale for Children
Description
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 .
Time Frame
Score will be obtained at baseline, 6 months posttreatment, yearly through 3 years posttreatment
Secondary Outcome Measure Information:
Title
3-year overall survival
Description
Overall survival is determined from the date of diagnosis to the date of death of any cause or the last follow-up visit
Time Frame
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.
Title
Short-term adverse effects of treatments
Description
NCI CTCAE 5.0 will be used for adverse effects evaluation
Time Frame
From the beginning to the completion of chemoradiotherapy, approximately 6 months. Grade 3/4 toxicities will be documented
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bo Li, MD,PhD
Phone
(86)10-59975581
Email
libo@bjtth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tao Jiang, MD, PhD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
ZIP/Postal Code
100070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Li, MD,PhD
Phone
(86)10-59975581
Email
libo@bjtth.org
12. IPD Sharing Statement
Learn more about this trial
The Efficacy of WVI in Patients With Localized Basal Ganglia Intracranial Germ Cell Tumors
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