Investigating Bevacizumab for brain injury from radiotherapy
Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury in Patients With Head and Neck Cancer
This study is testing if Bevacizumab can help people with head and neck cancer who have early signs of brain injury from radiation treatment but aren't showing any symptoms yet.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | Bevacizumab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05303259 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of Bevacizumab on patients with asymptomatic radiotherapy-induced brain injury (RI) who have head and neck cancer. The study is designed as a multicenter, randomized trial to assess both the efficacy and safety of Bevacizumab in this specific patient population. Given that previous research has focused on symptomatic RI, this trial seeks to determine whether early intervention is beneficial for those who do not yet exhibit clinical symptoms. Participants will undergo head MRI to confirm the presence of RI lesions before being enrolled in the study.
Who should consider this trial
Good fit: Ideal candidates for this study are head and neck cancer patients with MRI-confirmed asymptomatic radiotherapy-induced brain lesions.
Not a fit: Patients who already exhibit clinical symptoms of radiotherapy-induced brain injury will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could prevent the progression of brain injury in patients who currently show no symptoms.
How similar studies have performed: While previous studies have shown Bevacizumab's effectiveness in symptomatic cases, this approach for asymptomatic patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-Sen Memorial Hospital — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Yamei Tang, PHD
- Email: tangym@mail.sysu.edu.cn
- Phone: +86 13556001992
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.