Bevacizumab as a treatment for radiation necrosis of brain metastases post stereotactic radiosurgery.
Dustin Boothe, Robert Young, Yoshiya Yamada...
https://pubmed.ncbi.nlm.nih.gov/23814264Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID07481786
Bevacizumab Plus Fractionated Stereotactic Radiotherapy Versus Hippocampus-Avoidant Whole-Brain Radiotherapy With Simultaneous Integrated Boost in Lung Adenocarcinoma Patients With Extensive Brain Metastases A Phase 3 Randomized Trial
Led by Sun Yat-sen University · Updated on 2026-04-06
220
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two different brain-directed treatment strategies for adults with extensive brain metastases from lung adenocarcinoma in a phase 3 randomized clinical trial. The study aims to compare fractionated stereotactic radiotherapy combined with bevacizumab (FSRT-Bev) against hippocampus-avoidant whole-brain radiotherapy with simultaneous integrated boost (HA-WBRT-SIB). The goal is to assess which approach better controls intracranial tumors and preserves neurocognitive function. Participants are randomly assigned to one of two groups. The experimental group receives FSRT targeting visible brain tumors over 5 daily sessions with a total dose of 30 Gy, alongside bevacizumab given intravenously every 3 weeks for 4 cycles starting one week before radiotherapy. The control group undergoes hippocampus-avoidant whole-brain radiotherapy at 25 Gy with a simultaneous boost to metastatic lesions totaling 40 Gy over 10 daily treatments. Throughout the study, participants undergo regular assessments including neurocognitive tests like the Hopkins Verbal Learning Test-Revised, Controlled Oral Word Association Test, and Trail Making Tests. Researchers monitor intracranial progression-free survival over 18 months and neurocognitive function failure at 6 months post-radiotherapy. Additional evaluations include overall survival, quality of life, and safety over 18 months. The trial involves continuous monitoring and follow-up to evaluate treatment effects and participant well-being.
CONDITIONS
Brief Title
Bevacizumab Plus FSRT Versus Hippocampus-Avoidant WBRT in Lung Adenocarcinoma With Extensive Brain Metastases
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed non-squamous non-small cell lung cancer (adenocarcinoma)
- Extensive brain metastases with either 1-2 lesions (one ≥3 cm), or 3-10 lesions (one ≥2 cm), or 11-20 lesions
- Stable disease outside the brain
- ECOG performance status of 0 to 2
- Adequate bone marrow, liver, and kidney function
- Provided written informed consent
You will not qualify if you...
- Contraindications to bevacizumab such as uncontrolled hypertension, history of bleeding or blood clots, or recent surgery
- Presence of leptomeningeal metastasis
- Previous brain radiotherapy or brain surgery
- Severe brain swelling requiring urgent surgery
- Serious heart, blood vessel, or digestive diseases within the last 6 months
- Significant proteinuria (≥3+ or >1 g in 24-hour urine)
- Other active cancers except certain skin or cervical cancers
- Unable to complete neurocognitive testing
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 4 to 6 weeks
Participants receive one of two treatments: FSRT combined with bevacizumab or hippocampus-avoidant whole-brain radiotherapy with simultaneous integrated boost. FSRT is given in 5 daily fractions, and bevacizumab is administered every 3 weeks for 4 cycles starting one week before FSRT. Alternatively, whole-brain radiotherapy with hippocampal avoidance and simultaneous integrated boost is delivered in 10 daily fractions.
5 daily visits for FSRT and 4 bevacizumab infusions every 3 weeks OR 10 daily visits for whole-brain radiotherapy
Follow-up
Duration - Up to 18 months
Participants are monitored for intracranial progression, neurocognitive function, quality of life, and safety outcomes after treatment completion.
Periodic visits for assessments over 18 months
Trial Site Locations
Total: 3 locations
1
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016
Actively Recruiting
2
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
3
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China, 510405
Actively Recruiting
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Research Team
H
Hui Liu
B
Bo Qiu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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