Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury

Brain Injuries Clinical Trial

— BRAIN  

Official title:

Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury in Patients With Head and Neck Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05303259
• Other study ID #: 2021-KY-095
• Status: Recruiting
• Phase: Phase 2
• Start date: November 1, 2021
• Est. completion date: December 30, 2025

Study information

• Verified date: July 2021
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Yamei Tang, PHD
• Phone: +86 13556001992
• Email: tangym[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the effect of Bevacizumab on asymptomatic radiotherapy-induced brain injury patients with head and neck cancer.

Description:

Radiotherapy-induced brain injury (RI) is a serious complication of radiotherapy in head and neck cancer (HNC) patients. Previous studies have confirmed that Bevacizumab has a good effect on patients with symptomatic RI .However, patients with RI maybe do not show clinical symptoms in the early stage. The clinical symptoms will appear with the progression of the RI lesion. There has been no relevant research on whether early intervention is necessary for asymptomatic RI. The investigators conduct this multicenter, randomized clinical research to explore the efficacy and safety of Bevacizumab in asymptomatic RI.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Head MRI confirmed RI lesions. Sign the informed consent.

Exclusion Criteria:

With clinical symptoms of RI lesions. Head MRI showed bleeding lesions Contraindications of Bevacizumab. Pregnant women and parturient women.

Related Conditions & MeSH terms

• Brain Injuries
• Wounds and Injuries

Intervention

Drug:
• Bevacizumab
Bevacizumab 2.5mg/kg, q2w, 4 cycles.

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence and duration of onset of clinical symptoms.	The incidence and duration of onset of clinical symptoms within 1 year after treatment between the treatment group and the control group.	Change form baseline to evaluation at 1 year.
Secondary	change of RI volume.	The change of RI volume between the treatment group and the control group.	Change form baseline to evaluation at 1 year.
Secondary	change of cognitive function.	The change of cognitive function (MoCa scores) between the treatment group and the control group. The MoCA score ranges from 0 to 30, and higher scores mean a better outcome.	Change form baseline to evaluation at 1 year.
Secondary	overall survival	the overall survival between the treatment group and the control group.	Change form baseline to evaluation at 1 year.
Secondary	change of quality of life.	The change of quality of life ( WHOQOL scale) between the treatment group and the control group. The higher the QOL scores mean a better outcome.	Change form baseline to evaluation at 1 year.