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

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Primary Purpose

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Whole-ventricle irradiation

Carboplatin/etoposide

Ifosfamide/cisplatin/etoposide

Second-look surgery

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

3 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Intracranial Germ Cell CNS Tumor, Childhood

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial