Targeted FSRT plus bevacizumab versus hippocampus-sparing whole-brain radiation for people with lung adenocarcinoma that has spread to the brain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, phase 3 randomized trial comparing two brain-directed approaches for adults with extensive brain metastases from lung adenocarcinoma. Participants are randomized 1:1 to receive either FSRT (30 Gy in 5 fractions) combined with intravenous bevacizumab every 3 weeks for four cycles, or hippocampus-avoidant whole-brain radiotherapy (25 Gy) with a simultaneous integrated boost to lesions (40 Gy total) over 10 fractions. The trial's main goals are to improve intracranial tumor control while preserving neurocognitive function, with secondary assessments of safety and overall outcomes. The study is conducted at Sun Yat-sen University Cancer Center and two affiliated hospitals in China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* Contraindications to bevacizumab (uncontrolled hypertension, history of bleeding/thromboembolism, recent surgery, etc.)
* Leptomeningeal metastasis
* Prior brain radiotherapy or surgical resection of brain metastases
* Significant mass effect requiring urgent neurosurgical intervention
* Severe cardiovascular, vascular, or gastrointestinal disease within 6 months
* Proteinuria ≥3+ or 24-hour urine protein \>1 g
* Other active malignancies (except curable non-melanoma skin cancer or cervical carcinoma in situ)
* Inability to comply with neurocognitive testing
* Pregnancy or breastfeeding

Where it's running

• The First Affiliated Hospital of Chongqing Medical University
  Chongqing, Chongqing Municipality, China Recruiting
• Sun yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• The First Affiliated Hospital of Guangzhou University of Chinese Medicine
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Hui Liu
• Email: liuhuisysucc@126.com
• Phone: 02087343031

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.