Study of Tomotherapy HD in Medulloblastoma

September 16, 2018 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Recruiting
        • The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:
        • Principal Investigator:
          • Mawei Jiang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 3DCRT
This arm will be planned by 3DCRT to the treatment of the Medulloblastoma
Device: 3DCRT
Patients with Medulloblastoma receiving Three-Dimensional Conformal Radiation Therapy
Experimental: Tomotherapy HD，TOMO
This arm will be planned by TOMO to the treatment of the Medulloblastoma
Device: Tomotherapy HD
Patients with Medulloblastoma receiving Tomotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QoL(quality of life)
Time Frame: 2 years
Changes in quality of life were assessed by EORTC QLQ-C30
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS (progression free survival)
Time Frame: 2 years
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 ).
2 years
OS (overall survival)
Time Frame: 2 years
from the first day of therapy to death or last follow-up
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: mawei jiang, MD, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2018

Primary Completion (Anticipated)

May 30, 2019

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

September 16, 2018

First Submitted That Met QC Criteria

September 16, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-18-012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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