FSRT Combines With Bevacizumab for Multiple Brain Metastases in Lung Adenocarcinoma

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-Sen University Cancer Center

About this trial

For non-small cell lung cancer brain metastases, stereotactic radiotherapy is gradually replacing whole brain radiotherapy as the standard treatment. When patients have multiple brain metastases or larger tumors (diameter\>2cm), single session stereotactic radiotherapy (SRS) may cause significant neurological damage, so fractionated stereotactic radiotherapy (FSRT) is often used. The recent objective remission rate of FSRT is about 50%, and the 1-year intracranial control rate is about 45%, but intracranial progression remains the main factor affecting long-term survival of patients.

Bevacizumab is a recombinant humanized monoclonal antibody against vascular endothelial growth factor, which can improve the efficacy of cranial radiotherapy by normalizing neovascularization and improving the hypoxic state of tumor cells. In addition, bevacizumab can improve the abnormal permeability of neovascularization, reduce exudation and extracellular brain edema, thereby further alleviating the toxic side effects associated with brain radiotherapy.

Based on this, this prospective, controlled phase III study will explore the efficacy and safety of the combined use of fractionated stereotactic radiotherapy and bevacizumab in multiple brain metastases of lung adenocarcinoma.

Eligibility criteria

Qualifiers

Age ≥ 18 years old;

Cellular or histopathological confirmation of lung adenocarcinoma;

Prior to enrollment, brain enhanced magnetic resonance imaging shows (1) 1-2 brain metastases, with at least one measuring ≥3 cm in diameter; or (2) 3-10 brain metastases, with at least one measuring ≥2 cm in diameter; or (3) 11-20 brain metastases; and deemed unsuitable for single-session SRS by radiation oncologists;

At the time of enrollment, the extracranial disease status is stable;

Disqualifiers

There are contraindications for bevacizumab, such as a history of cardiac and/or thromboembolic events, or uncontrolled hypertension;

Meningeal metastasis or extensive intracranial metastasis are not suitable for FSRT;

Bleeding tendency or coagulation dysfunction;

Patients with hemoptysis (≥ 1/2 teaspoon of fresh blood per day) within the past month;

Trial design

Treatments tested in this trial

  • Bevacizumab
  • FSRT
  • Whole brain radiotherapy

Treatment groups

258 Participants
are divided into 3 treatment groups