Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University204 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

204

Conditions

Brain Injuries

Interventions

BevacizumabDRUG

Bevacizumab 2.5mg/kg, q2w, 4 cycles.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

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.