Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury

NCT ID: NCT05303259

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2025-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Brain Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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HNC patients with radiation-induced brain injury.

Bevacizumab 2.5mg/kg, q2w,4 cycles.

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

Bevacizumab 2.5mg/kg, q2w, 4 cycles.

HNC patients without brain injury after radiotherapy.

No treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bevacizumab

Bevacizumab 2.5mg/kg, q2w, 4 cycles.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yamei Tang, Ph.D

Role: STUDY_CHAIR

sun yat-sen memorial hospital,sun yat-sen universicy

Locations

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Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yamei Tang, PHD

Role: CONTACT

+86 13556001992

Facility Contacts

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Yamei Tang, PHD

Role: primary

+86 13556001992

Other Identifiers

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2021-KY-095

Identifier Type: -

Identifier Source: org_study_id

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