Study of Tomotherapy HD in Medulloblastoma

Medulloblastoma Clinical Trial

Official title:

Study of Tomotherapy HD in Medulloblastoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03675230
• Other study ID #: XH-18-012
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2018
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: chuanying zhu, MD
• Phone: 13795327309
• Email: zhuchuanying[@]xinhuamed.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: June 30, 2020
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Medulloblastoma

Intervention

Device:
• Tomotherapy HD
Patients with Medulloblastoma receiving Tomotherapy
• 3DCRT
Patients with Medulloblastoma receiving Three-Dimensional Conformal Radiation Therapy

Locations

Country	Name	City	State
China	The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QoL(quality of life)	Changes in quality of life were assessed by EORTC QLQ-C30	2 years
Secondary	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 ).	2 years
Secondary	OS (overall survival)	from the first day of therapy to death or last follow-up	2 years