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

Primary Purpose

Brain Injuries

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Bevacizumab
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sun Yat-Sen Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HNC patients with radiation-induced brain injury.

HNC patients without brain injury after radiotherapy.

Arm Description

Bevacizumab 2.5mg/kg， q2w，4 cycles.

No treatment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

change of RI volume.
The change of RI volume between the treatment group and the control group.
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.
overall survival
the overall survival between the treatment group and the control group.
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.

Full Information

First Posted
December 19, 2021
Last Updated
March 20, 2022
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05303259
Brief Title
Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury
Acronym
BRAIN
Official Title
Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury in Patients With Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HNC patients with radiation-induced brain injury.
Arm Type
Experimental
Arm Description
Bevacizumab 2.5mg/kg， q2w，4 cycles.
Arm Title
HNC patients without brain injury after radiotherapy.
Arm Type
No Intervention
Arm Description
No treatment.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
Bevacizumab 2.5mg/kg, q2w, 4 cycles.
Primary Outcome Measure Information:
Title
The incidence and duration of onset of clinical symptoms.
Description
The incidence and duration of onset of clinical symptoms within 1 year after treatment between the treatment group and the control group.
Time Frame
Change form baseline to evaluation at 1 year.
Secondary Outcome Measure Information:
Title
change of RI volume.
Description
The change of RI volume between the treatment group and the control group.
Time Frame
Change form baseline to evaluation at 1 year.
Title
change of cognitive function.
Description
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.
Time Frame
Change form baseline to evaluation at 1 year.
Title
overall survival
Description
the overall survival between the treatment group and the control group.
Time Frame
Change form baseline to evaluation at 1 year.
Title
change of quality of life.
Description
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.
Time Frame
Change form baseline to evaluation at 1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yamei Tang, PHD
Phone
+86 13556001992
Email
tangym@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yamei Tang, Ph.D
Organizational Affiliation
sun yat-sen memorial hospital,sun yat-sen universicy
Official's Role
Study Chair
Facility Information:
Facility Name
Sun Yat-Sen Memorial Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yamei Tang, PHD
Phone
+86 13556001992
Email
tangym@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury

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