NCT03675230

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

September 18, 2018

Status Verified

July 1, 2018

Enrollment Period

1.4 years

First QC Date

September 16, 2018

Last Update Submit

September 16, 2018

Conditions

Medulloblastoma

Keywords

TOMO irradiation

Outcome Measures

Primary Outcomes (1)

  • QoL(quality of life)

    Changes in quality of life were assessed by EORTC QLQ-C30

    2 years

Secondary Outcomes (2)

  • PFS (progression free survival)

    2 years

  • OS (overall survival)

    2 years

Study Arms (2)

3DCRT

ACTIVE COMPARATOR

This arm will be planned by 3DCRT to the treatment of the Medulloblastoma

Device: 3DCRT

Tomotherapy HD，TOMO

EXPERIMENTAL

This arm will be planned by TOMO to the treatment of the Medulloblastoma

Device: Tomotherapy HD

Interventions

Tomotherapy HDDEVICE

Patients with Medulloblastoma receiving Tomotherapy

Tomotherapy HD，TOMO
3DCRTDEVICE

Patients with Medulloblastoma receiving Three-Dimensional Conformal Radiation Therapy

3DCRT

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Previous radiotherapy in the whole brain, whole spinal cord or primary focus; Postoperative radiotherapy for more than 28 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Conditions

Medulloblastoma

Condition Hierarchy (Ancestors)

GliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeuroectodermal Tumors, PrimitiveNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • mawei jiang, MD

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

chuanying zhu, MD

CONTACT

13795327309zhuchuanying@xinhuamed.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2018

First Posted

September 18, 2018

Study Start

January 12, 2018

Primary Completion

May 30, 2019

Study Completion

June 30, 2020

Last Updated

September 18, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)