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FSRT Combines With Bevacizumab for Multiple Brain Metastases in Lung Adenocarcinoma

ConditionMultiple 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Bevacizumab

    Drug

    Bevacizumab starts on day 1 (one week before FSRT treatment), q3w，a total of 4 treatment courses, intravenous injection, with a dose of 7.5mg/kg.

  • FSRT

    Radiation

    The FSRT group received simple FSRT radiotherapy; FSRT is targeted at visible intracranial lesions, with a total dose of 30Gy, administered once a day for a total of 5 days, with a fraction dose of 6Gy.

  • Whole brain radiotherapy

    Radiation

    The WBRT group received whole brain radiotherapy and locally increased dose radiotherapy for visible intracranial lesions, with a total dose of 40Gy for local lesions and 25Gy for the whole brain, once a day for a total of 10 days.

Treatment groups

258 Participants
are divided into 3 treatment groups
Group A: The FSRT+beva groupExperimental treatment 2 interventions
Group B: The FSRT groupActive comparator 1 intervention
Group C: The WBRT groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intracranial progression free survival

the time interval from the end of radiotherapy to the first occurrence of intracranial progression or death or the last follow-up;

Time frame
2 years

Secondary outcomes

1

Progress free survival

Progress free survival (PFS) is defined as the time interval from the end of radiotherapy to the first occurrence of disease progression or death or the last follow-up

Time frame
2 years
2

Overall survival

Overall survival (OS) is defined as the time interval from the end of radiotherapy to the occurrence of death or the last follow-up

Time frame
2 years
3

The quality of life (QOL)

The quality of life (QOL) is evaluated using the European Organization for Research and Treatment of Cancer QOL questionnaire version 3.0 (QLQ-C30).

Time frame
2 years
4

Treatment related side effects

Graded according to CTCAE 5.0

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-Sen University Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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