NCT07481786RecruitingPhase 3
Bevacizumab Plus FSRT Versus Hippocampus-Avoidant WBRT in Lung Adenocarcinoma With Extensive Brain Metastases
Application of Bevacizumab Combined With Fractionated Stereotactic Radiotherapy (FSRT-Bev) Versus Hippocampus-Avoidant Whole-Brain Radiotherapy With Simultaneous Integrated Boost (HA-WBRT-SIB) in Patients With Extensive Brain Metastases From Lung Adenocarcinoma: A Phase III Randomized Controlled Trial Evaluating Intracranial Control Efficacy and Neurocognitive Function
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
This is a phase 3, randomized, controlled clinical trial comparing two brain-directed treatment strategies for adult patients with extensive brain metastases from lung adenocarcinoma. The trial compares fractionated stereotactic radiotherapy combined with bevacizumab (FSRT-Bev) versus hippocampus-avoidant whole-brain radiotherapy with simultaneous integrated boost (HA-WBRT-SIB). The main objectives are to evaluate intracranial tumor control and preservation of neurocognitive function . Patients will be randomly assigned in a 1:1 ratio to receive either FSRT plus bevacizumab or HA-WBRT-SIB. In the experimental group, FSRT is delivered to visible brain tumors over 5 daily treatments (total 30 Gy, 6 Gy per fraction). Bevacizumab is given intravenously every 3 weeks for 4 cycles. In the control group, patients receive hippocampus-avoidant whole-brain radiation (25 Gy) with a simultaneous dose boost to metastatic lesions (40 Gy total) over 10 daily treatments.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 15 Mar 2026
- Start date
- 20 Mar 2026
- Primary completion date
- 15 Sept 2029
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Lung cancer
- NCT number
- NCT07481786
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 220
- From 20 Mar 2026 to the primary completion date, 15 Sept 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior brain radiotherapy or surgical resection of brain metastases
Other illness
- Contraindications to bevacizumab (uncontrolled hypertension, history of bleeding/thromboembolism, recent surgery, etc.)
- Severe cardiovascular, vascular, or gastrointestinal disease within 6 months
- Other active malignancies (except curable non-melanoma skin cancer or cervical carcinoma in situ)
Other
- Leptomeningeal metastasis
- Significant mass effect requiring urgent neurosurgical intervention
- Proteinuria ≥3+ or 24-hour urine protein \>1 g
- Inability to comply with neurocognitive testing
- Pregnancy or breastfeeding
Who the study is looking for
- Age ≥18 years
- Pathologically confirmed non-squamous non-small cell lung cancer (adenocarcinoma)
- Extensive brain metastases meeting any of the following:
- 1-2 metastases with at least one ≥3 cm in diameter; or 3-10 metastases with at least one ≥2 cm; or 11-20 metastases
- Stable extracranial disease
- ECOG performance status 0-2
- Adequate bone marrow, hepatic, and renal function
- Written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| The First Affiliated Hospital of Guangzhou University of Chinese Medicine Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.