Back to resultsStudy of Tomotherapy HD in Medulloblastoma
Primary Purpose
Medulloblastoma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tomotherapy HD
3DCRT
Sponsored by
About this trial
This is an interventional treatment trial for Medulloblastoma focused on measuring TOMO irradiation
Eligibility Criteria
Inclusion Criteria:
- The patient was diagnosed as myeloblastoma by surgical pathology with definite pathological classification. MRI of the head and spinal cord before and after operation, with definite staging; Radiotherapy was performed within 28 days after surgery.
Exclusion Criteria:
- Previous radiotherapy in the whole brain, whole spinal cord or primary focus; Postoperative radiotherapy for more than 28 days.
Sites / Locations
- The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
3DCRT
Tomotherapy HD，TOMO
Arm Description
This arm will be planned by 3DCRT to the treatment of the Medulloblastoma
This arm will be planned by TOMO to the treatment of the Medulloblastoma
Outcomes
Primary Outcome Measures
QoL(quality of life)
Changes in quality of life were assessed by EORTC QLQ-C30
Secondary Outcome Measures
PFS (progression free survival)
from the first day of therapy to the date of disease progression or death from any cause, whichever was first (according the criterion of RECIST 1.1 ).
OS (overall survival)
from the first day of therapy to death or last follow-up
Full Information
NCT ID
NCT03675230
First Posted
September 16, 2018
Last Updated
September 16, 2018
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03675230
Brief Title
Study of Tomotherapy HD in Medulloblastoma
Official Title
Study of Tomotherapy HD in Medulloblastoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 12, 2018 (Actual)
Primary Completion Date
May 30, 2019 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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
The aim of the study was to improve local control and long-term survival in children with medulloblastoma, reduce the side effects of treatment and improve quality of life.
Detailed Description
The technical advantages of Tomotherapy HD in the radiotherapy of children medulloblastoma (advantages in clinical operation and physics) were transformed into clinical advantages, and the possible mechanisms were explored.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medulloblastoma
Keywords
TOMO irradiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3DCRT
Arm Type
Active Comparator
Arm Description
This arm will be planned by 3DCRT to the treatment of the Medulloblastoma
Arm Title
Tomotherapy HD，TOMO
Arm Type
Experimental
Arm Description
This arm will be planned by TOMO to the treatment of the Medulloblastoma
Intervention Type
Device
Intervention Name(s)
Tomotherapy HD
Intervention Description
Patients with Medulloblastoma receiving Tomotherapy
Intervention Type
Device
Intervention Name(s)
3DCRT
Intervention Description
Patients with Medulloblastoma receiving Three-Dimensional Conformal Radiation Therapy
Primary Outcome Measure Information:
Title
QoL(quality of life)
Description
Changes in quality of life were assessed by EORTC QLQ-C30
Time Frame
2 years
Secondary Outcome Measure Information:
Title
PFS (progression free survival)
Description
from the first day of therapy to the date of disease progression or death from any cause, whichever was first (according the criterion of RECIST 1.1 ).
Time Frame
2 years
Title
OS (overall survival)
Description
from the first day of therapy to death or last follow-up
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient was diagnosed as myeloblastoma by surgical pathology with definite pathological classification. MRI of the head and spinal cord before and after operation, with definite staging; Radiotherapy was performed within 28 days after surgery.
Exclusion Criteria:
Previous radiotherapy in the whole brain, whole spinal cord or primary focus; Postoperative radiotherapy for more than 28 days.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
chuanying zhu, MD
Phone
13795327309
Email
zhuchuanying@xinhuamed.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mawei jiang, MD
Organizational Affiliation
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuanying zhu, MD
Phone
862125076994
Email
sdnanhai123@163.com
First Name & Middle Initial & Last Name & Degree
Mawei Jiang, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Tomotherapy HD in Medulloblastoma
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