Study of Tomotherapy HD in Medulloblastoma

Not Applicable

• Conditions: Medulloblastoma
• Interventions: Device: Tomotherapy HD; Device: 3DCRT

• Registration Number: NCT03675230
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Study Start: 2018-01-12
• Status Verified: 2018-07
• Study First Submitted: 2018-09-16
• Study First Submitted QC: 2018-09-16
• Last Update Submitted: 2018-09-16
• Study First Posted: 2018-09-18
• Last Update Posted: 2018-09-18
• Primary Completion: 2019-05-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tomotherapy HD，TOMO	Tomotherapy HD	This arm will be planned by TOMO to the treatment of the Medulloblastoma
3DCRT	3DCRT	This arm will be planned by 3DCRT to the treatment of the Medulloblastoma

Primary Outcome Measures

Name	Time	Method
QoL(quality of life)	2 years	Changes in quality of life were assessed by EORTC QLQ-C30

Secondary Outcome Measures

Name	Time	Method
PFS (progression free survival)	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 ).
OS (overall survival)	2 years	from the first day of therapy to death or last follow-up

Trial Locations

Locations (1)

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