Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury (BRAIN)

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

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

Study Overview

• Status: Recruiting
• Conditions: Brain Injuries
• Intervention / Treatment: Drug: Bevacizumab

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 204
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yamei Tang, PHD; Phone Number: +86 13556001992; Email: tangym@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-sen Memorial Hospital
      • Contact: Yamei Tang, PHD; Phone Number: +86 13556001992; Email: tangym@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HNC patients with radiation-induced brain injury.; Bevacizumab 2.5mg/kg， q2w，4 cycles.	Drug: Bevacizumab; Bevacizumab 2.5mg/kg, q2w, 4 cycles.
NO_INTERVENTION: HNC patients without brain injury after radiotherapy.; No treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
overall survival	the overall survival between the treatment group and the control group.	Change form baseline to evaluation at 1 year.
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.

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Study Chair: Yamei Tang, Ph.D, sun yat-sen memorial hospital,sun yat-sen universicy

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2021
• Primary Completion (ANTICIPATED): December 30, 2024
• Study Completion (ANTICIPATED): December 30, 2025

Study Registration Dates

• First Submitted: December 19, 2021
• First Submitted That Met QC Criteria: March 20, 2022
• First Posted (ACTUAL): March 31, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 20, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: 2021-KY-095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No