BRAIN: Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05303259
Collaborator
(none)
204
1
2
49.9
4.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
204 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury in Patients With Head and Neck Cancer
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Dec 30, 2024
Anticipated Study Completion Date :
Dec 30, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The incidence and duration of onset of clinical symptoms. [Change form baseline to evaluation at 1 year.]

    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

  1. change of RI volume. [Change form baseline to evaluation at 1 year.]

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

  2. change of cognitive function. [Change form baseline to evaluation at 1 year.]

    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.

  3. overall survival [Change form baseline to evaluation at 1 year.]

    the overall survival between the treatment group and the control group.

  4. change of quality of life. [Change form baseline to evaluation at 1 year.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sun Yat-Sen Memorial Hospital Guangzhou Guangdong China 510120

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT05303259
Other Study ID Numbers:
  • 2021-KY-095
First Posted:
Mar 31, 2022
Last Update Posted:
Mar 31, 2022
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022