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Treatment of CNS germinoma using chemotherapy followed by reduced dose radiotherapy

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

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005442
    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

    Institutional Review Board Information
    Board Approval Status Submitted approval
    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 Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    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

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    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

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Samsung Medical Center
    Organization Type Medical Institute
    Project ID SMC 2020-03-145-004
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Samsung Medical Center
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    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.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    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

    Subject Eligibility Information
    Condition(s)/Problem(s) * (C00-D48)Neoplasms 
       (C72.9)Malignant neoplasm of central nervous system, unspecified 

    Central nervous system germinoma
    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)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    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

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2030. 12
    Way of Sharing Available on Request
    (leejw.lee@samsung.com)
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