Back to resultsReduced Dose Radiotherapy Following High Dose Chemotherapy in Intracranial Non-germinomatous Germ Cell Tumor
Primary Purpose
Intracranial Non-germinomatous Germ Cell Tumor
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Carboplatin
Etoposide
Cyclophosphamide
Bleomycin
Thiotepa
Melphalan
Reduced dose radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Non-germinomatous Germ Cell Tumor
Eligibility Criteria
Inclusion Criteria:
- Patients with pathologically proven intracranial non-germinomatous germ cell tumor or
- Patients who have brain mass which are suspected as intracranial germ cell tumor and elevated serum or cerebrospinal fluid alpha-feto protein.
Exclusion Criteria:
- Patients with organ dysfunction (ejection fraction <40%, creatinine > 3 x upper limit of normal (ULN), aspartate aminotransferase/alanine aminotransaminase > 5 x ULN).
- Pregnant or nursing women
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intracranial NGGCT
Arm Description
Six cycles of chemotherapy with carboplatin, etoposide, bleomycin (CEB) and cyclophosphamide, etoposide, bleomycin (CyEB) regimen. Peripheral blood stem cell collection during the first cycle of chemotherapy. Surgery, if there is residual tumor after chemotherapy. Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation (auto-SCT) 1st HDCT: Carboplatin, thiotepa, etoposide 2nd HDCT: Cyclophosphamide, melphalan Reduced dose of radiotherapy
Outcomes
Primary Outcome Measures
Rate of event free survival
Secondary Outcome Measures
Rate of late adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02784054
Brief Title
Reduced Dose Radiotherapy Following High Dose Chemotherapy in Intracranial Non-germinomatous Germ Cell Tumor
Official Title
Reduced-dose Radiotherapy Following High-dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With Central Nervous System Non-germinomatous Germ Cell Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the outcome of intracranial non-germinomatous germ cell tumor (NGGCT) treated with reduced radiotherapy following high dose chemotherapy and autologous stem cell transplantation (HDCT/auto-SCT).
Detailed Description
Treatment outcome of intracranial NGGCT is around 50% with conventional chemo- and radiotherapy. Also, late sequelae such as endocrinopathy or cognitive problem are unavoidable especially with craniospinal irradiation. In this study, high dose chemotherapy and reduced dose of radiotherapy will be used to improve survival and minimize the late sequelae in the patients with intracranial NGGCT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Non-germinomatous Germ Cell Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intracranial NGGCT
Arm Type
Experimental
Arm Description
Six cycles of chemotherapy with carboplatin, etoposide, bleomycin (CEB) and cyclophosphamide, etoposide, bleomycin (CyEB) regimen.
Peripheral blood stem cell collection during the first cycle of chemotherapy.
Surgery, if there is residual tumor after chemotherapy.
Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation (auto-SCT)
1st HDCT: Carboplatin, thiotepa, etoposide
2nd HDCT: Cyclophosphamide, melphalan
Reduced dose of radiotherapy
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Bleomycin
Intervention Type
Drug
Intervention Name(s)
Thiotepa
Intervention Type
Drug
Intervention Name(s)
Melphalan
Intervention Type
Radiation
Intervention Name(s)
Reduced dose radiotherapy
Primary Outcome Measure Information:
Title
Rate of event free survival
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Rate of late adverse events
Time Frame
Up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with pathologically proven intracranial non-germinomatous germ cell tumor or
Patients who have brain mass which are suspected as intracranial germ cell tumor and elevated serum or cerebrospinal fluid alpha-feto protein.
Exclusion Criteria:
Patients with organ dysfunction (ejection fraction <40%, creatinine > 3 x upper limit of normal (ULN), aspartate aminotransferase/alanine aminotransaminase > 5 x ULN).
Pregnant or nursing women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ki Woong Sung, MD, PhD
Phone
82-2-3410-3529
Email
kiwoong.sung@samsung.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki Woong Sung
Phone
82-2-3410-3529
Email
kwsped@skku.edu
First Name & Middle Initial & Last Name & Degree
Ki Woong Sung
12. IPD Sharing Statement
Learn more about this trial
Reduced Dose Radiotherapy Following High Dose Chemotherapy in Intracranial Non-germinomatous Germ Cell Tumor
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