Status Approved
First Submitted Date
2020/09/17
Registered Date
2020/09/25
Last Updated Date
2023/11/16
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005442 |
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Unique Protocol ID | SMC 2020-03-145 |
Public/Brief Title | Treatment of CNS germinoma with chemotherapy and radiotherapy |
Scientific Title | Treatment of CNS germinoma using chemotherapy followed by reduced dose radiotherapy |
Acronym | |
MFDS Regulated Study | Yes |
IND/IDE Protocol | |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Submitted approval |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | SMC 2020-03-145-004 |
Approval Date | 2020-08-19 |
Institutional Review Board Name | Samsung Medical Center Institutional Review Board |
Institutional Review Board Address | 81, Irwon-ro, Gangnam-gu, Seoul |
Institutional Review Board Telephone | 02-3410-2973 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
---|---|
Name | Ki Woong Sung |
Title | Professor |
Telephone | +82-2-3410-3539 |
Affiliation | Samsung Medical Center |
Address | 81 Irwon-ro, Gangnam-gu, Seoul |
Contact Person for Public Queries | |
Name | Ji Won Lee |
Title | Associate Professor |
Telephone | +82-2-3410-0659 |
Affiliation | Samsung Medical Center |
Address | 81 Irwon-ro, Gangnam-gu, Seoul |
Contact Person for Updating Information | |
Name | Ji Won Lee |
Title | Associate Professor |
Telephone | +82-2-3410-0659 |
Affiliation | Samsung Medical Center |
Address | 81 Irwon-ro, Gangnam-gu, Seoul |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Active, not recruiting | |
Date of First Enrollment | 2021-01-05 Actual | |
Target Number of Participant | 44 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Samsung Medical Center | |
Recruitment Status | Active, not recruiting | |
Date of First Enrollment | 2021-01-05 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Samsung Medical Center |
Organization Type | Medical Institute |
Project ID | SMC 2020-03-145-004 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Samsung Medical Center |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Central nervous system (CNS) germinomas respond well to radiation and chemotherapy, and radiotherapy alone reports a high survival rate of about 90%. Standard radiotherapy was craniospinal irradiation (CSI) followed by primary site radiotherapy. The treatment effect was excellent, but late side effects such as endocrine dysfunction and cognitive dysfunction were inevitable. With this background, recent studies have been conducted to reduce the field or dose of radiation therapy by attempting prior chemotherapy, and as a result, it has been reported that there is no difference in survival rate. However, there are no guidelines for the most appropriate chemotherapy or radiation therapy yet. On the other hand, there is controversy about the effect of an increase in b-HCG on the prognosis in CNS germinomas. Early studies suggested that the increase in b-HCG was associated with a poor prognosis, but recent studies show that the increase in b-HCG is not related to the prognosis. In our previous study, 4 cycles of chemotherapy were given prior to radiotherapy in CNS germinoma with b-hCG level < 200 mIU/mL. An 18 Gy of craniospinal RT for metastatic tumors, whole brain RT for basal ganglia tumors, or otherwise whole ventricular RT followed by 12.6 Gy of boost RT to the primary tumor bed was administered after the induction chemotherapy. This study resulted in a high 5-year event-free survival rate of 96.7 ± 3.3%. In this study, we explore the feasibility of further reduced dose of radiotherapy following induction chemotherapy in the treatment of CNS germinomas with b-hCG levels < 200 mIU/ml. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Not applicable |
Intervention Model | Single Group |
Blinding/Masking | Open |
Allocation | Not Applicable |
Intervention Type | Drug, Radiation |
Intervention Description | 1. Chemotherapy A regimen (CE): carboplatin 450 mg/m^2/day (d0), etoposide 150 mg/m^2/day (d0-2) B regimen (ECy): etoposide 150 mg/m^2/day (d0-2), cyclophosphamide 1,000 mg/m^2/day (d0-1) Total 6 cycles alternatively (every 3-4 weeks) 2. Radiotherapy 1) Localized tumor within ventricle: Whole ventricle 10.8 Gy + primary tumor 10.8 Gy 2) Localized tumor beyond ventricle: Whole brain 10.8 Gy + primary tumor 10.8 Gy 3) Metastatic tumor: Craniospinal irradiation 10.8 Gy + primary tumor 10.8 Gy |
Number of Arms | 1 |
Arm 1 |
Arm Label CNS germinoma with b-hCG level < 200 mIU/ml |
Target Number of Participant 44 |
|
Arm Type Experimental |
|
Arm Description 1. Chemotherapy A regimen (CE): carboplatin 450 mg/m^2/day (d0), etoposide 150 mg/m^2/day (d0-2) B regimen (ECy): etoposide 150 mg/m^2/day (d0-2), cyclophosphamide 1,000 mg/m^2/day (d0-1) Total 6 cycles alternatively (every 3-4 weeks) 2. Radiotherapy 1) Localized tumor within ventricle: Whole ventricle 10.8 Gy + primary tumor 10.8 Gy 2) Localized tumor beyond ventricle: Whole brain 10.8 Gy + primary tumor 10.8 Gy 3) Metastatic tumor: Craniospinal irradiation 10.8 Gy + primary tumor 10.8 Gy |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (C00-D48)Neoplasms (C72.9)Malignant neoplasm of central nervous system, unspecified Central nervous system germinoma |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 3Year~30Year |
|
Description 1) Pathologically proven CNS germinoma 2) Age: 3-30 years 3) Normal plasma and CSF aFP 4) Plasma and CSF b-hCG < 200 mIU/ml 5) Patients with informed consent |
|
Exclusion Criteria |
1) Patients with organ dysfunction as follows - Serum Cr > 1.5 x ULN or creatinine clearance ≤ 30 mL/min - Cardiac ejection fraction <40% or severe arrhythmia or conduction disorder 2) Other sever mediacal illness which makes scheduled treatment impossible 3) Pregnant or nursing women 4) Patients with a past history of severe hypersensitivity to clinical trial drugs 5) Patients who are currently using pentostatin |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | /Safety/Efficacy | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | Rate of event free survival |
|
Timepoint | Up to 5 years |
|
Secondary Outcome(s) 1 | ||
Outcome | Rate of late adverse effects |
|
Timepoint | Up to 5 years |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2030. 12 |
Way of Sharing | Available on Request
(leejw.lee@samsung.com) |
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