Intracranial Germ Cell CNS Tumor, ChildhoodPhase 2NCT05124951
The Efficacy of WVI in Patients With Localized Basal Ganglia Intracranial Germ Cell Tumors
A Phase 2 study testing Whole-ventricle irradiation, Carboplatin/etoposide and Ifosfamide/cisplatin/etoposide in people with Intracranial Germ Cell CNS Tumor, Childhood, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 30 years
- Conditions the study is for
- Intracranial Germ Cell CNS Tumor, Childhood
- What is being tested?
- Whole-ventricle irradiation, Carboplatin/etoposide and Ifosfamide/cisplatin/etoposide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2021to 31 Oct 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- Adequate organ function
- Written informed consent
- 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
Who cannot join
- 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
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- Inadequate organ function
- Poor compliance
- Stratum II: non-germinomatous germ cell tumors
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, 100070
Bo Li, MD,PhD, (86)10-59975581, libo@bjtth.org
About this study
Official title: The Efficacy of Whole-ventricle Irradiation Plus Primary Boost in Patients With Localized Basal Ganglia Germ Cell Tumors: Prospective Phase II Study
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
Read the 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.
- Being tested
- Whole-ventricle irradiation, Carboplatin/etoposide, Ifosfamide/cisplatin/etoposide, Second-look surgery
- Keywords
- intracranial germ cell tumors, basal ganglia, radiotherapy, target volume, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-ventricle irradiationRadiation
Whole-ventricle irradiation will be applied in patients with localized basal ganglia germ cell tumors after induction chemotherapy
Carboplatin/etoposideDrug
Carboplatin/etoposide regimen is applied as induction chemotherapy in patients with basal ganglia germinoma
Ifosfamide/cisplatin/etoposideDrug
Ifosfamide/cisplatin/etoposide regimen is applied as induction chemotherapy in patients with basal ganglia non-germinomatous germ cell tumors.
Second-look surgeryProcedure or surgery
Second-look surgery would be applied to patients who presented residue disease after induction chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| iGCTS | Experimental | 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. Receives: Radiation: Whole-ventricle irradiation; Drug: Carboplatin/etoposide; Drug: Ifosfamide/cisplatin/etoposide; Procedure: Second-look surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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)
Measured: Score will be obtained at baseline, 6 months posttreatment, yearly through 3 years posttreatment
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)
Measured: Evaluation will be conducted at baseline, 6 months posttreatment, yearly through 3 years posttreatment
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 .
Measured: Score will be obtained at baseline, 6 months posttreatment, yearly through 3 years posttreatment
Secondary outcomes (2)
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
Measured: 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
NCI CTCAE 5.0 will be used for adverse effects evaluation
Measured: From the beginning to the completion of chemoradiotherapy, approximately 6 months. Grade 3/4 toxicities will be documented
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start15 Sep 2021
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Germ Cell CNS Tumor, ChildhoodStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Jiang, Beijing Tiantan Hospital
- Investigators
- Tao Jiang, MD, PhD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124951
- Sponsor's protocol ID
- CHN-IGCT-001
- Status last verified
- Nov 2021
- First submitted
- 13 Oct 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Whole-ventricle Irradiation Plus Primary Boost in Patients With Localized Basal Ganglia Germ Cell Tumors: Prospective Phase II Study
- ClinicalTrials.gov ID
- NCT05124951
- Acronym / sponsor ID
- CHN-IGCT-001
- Keywords
- intracranial germ cell tumors, basal ganglia, radiotherapy, target volume, quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 18 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iGCTS | Experimental | Radiation: Whole-ventricle irradiation, Drug: Carboplatin/etoposide, Drug: Ifosfamide/cisplatin/etoposide, Procedure: Second-look surgeryStratum 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. |
Who may qualify
- Ages
- 3 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-ventricle irradiationWhole-ventricle irradiation will be applied in patients with localized basal ganglia germ cell tumors after induction chemotherapy | Radiation | iGCTS |
| Carboplatin/etoposideCarboplatin/etoposide regimen is applied as induction chemotherapy in patients with basal ganglia germinoma | Drug | iGCTS |
| Ifosfamide/cisplatin/etoposideIfosfamide/cisplatin/etoposide regimen is applied as induction chemotherapy in patients with basal ganglia non-germinomatous germ cell tumors. | Drug | iGCTS |
| Second-look surgerySecond-look surgery would be applied to patients who presented residue disease after induction chemotherapy. | Procedure or surgery | iGCTS |
Primary outcome
3-year event-free survival
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.
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)
Time frame: 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)
Time frame: 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
Time frame: 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 .
2 secondary outcomes
3-year overall survival
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.
Short-term adverse effects of treatments
Time frame: From the beginning to the completion of chemoradiotherapy, approximately 6 months. Grade 3/4 toxicities will be documented
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tao Jiang, MD, PhD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Whole-ventricle irradiation, Carboplatin/etoposide and Ifosfamide/cisplatin/etoposide in people with Intracranial Germ Cell CNS Tumor, Childhood, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bo Li, MD,PhD ((86)10-59975581, libo@bjtth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year event-free survival (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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021.