Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury
BRAIN
1 other identifier
interventional
204
1 country
1
Brief Summary
To investigate the effect of Bevacizumab on asymptomatic radiotherapy-induced brain injury patients with head and neck cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2021
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2021
CompletedFirst Submitted
Initial submission to the registry
December 19, 2021
CompletedFirst Posted
Study publicly available on registry
March 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedMarch 31, 2022
July 1, 2021
3.2 years
December 19, 2021
March 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
change of RI volume.
Change form baseline to evaluation at 1 year.
change of cognitive function.
Change form baseline to evaluation at 1 year.
overall survival
Change form baseline to evaluation at 1 year.
change of quality of life.
Change form baseline to evaluation at 1 year.
Study Arms (2)
HNC patients with radiation-induced brain injury.
EXPERIMENTALBevacizumab 2.5mg/kg， q2w，4 cycles.
HNC patients without brain injury after radiotherapy.
NO INTERVENTIONNo treatment.
Interventions
Bevacizumab 2.5mg/kg, q2w, 4 cycles.
Eligibility Criteria
You may qualify if:
- Head MRI confirmed RI lesions. Sign the informed consent.
You may not qualify if:
- With clinical symptoms of RI lesions. Head MRI showed bleeding lesions Contraindications of Bevacizumab. Pregnant women and parturient women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong, 510120, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yamei Tang, Ph.D
sun yat-sen memorial hospital,sun yat-sen universicy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2021
First Posted
March 31, 2022
Study Start
November 1, 2021
Primary Completion
December 30, 2024
Study Completion
December 30, 2025
Last Updated
March 31, 2022
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share