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Multiple Brain Metastases in Lung AdenocarcinomaPhase 3NCT07058428

FSRT Combines With Bevacizumab for Multiple Brain Metastases in Lung Adenocarcinoma

A Phase 3 study testing Bevacizumab, FSRT and Whole brain radiotherapy in people with Multiple Brain Metastases in Lung Adenocarcinoma, run by Sun Yat-Sen University Cancer Center at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bevacizumab, FSRT and Whole brain radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
258 participants
Where
1 siteChina
Study dates
30 Jun 2025to 30 Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
  • Eastern Cooperative Oncology Group (ECOG) physical fitness status score 0-2 points
  • Normal liver, kidney, and bone marrow function within 14 days prior to enrollment: peripheral blood white blood cell count ≥ 4 × 10^9/L; neutrophil count ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L, hemoglobin ≥ 100g/L, serum creatinine<1.5 times the upper limit of normal values; Bilirubin<1.5 times the upper limit of normal value; Transaminase<2 times the upper limit of normal value;
  • The patient and their family agree and sign an informed consent form.

Who cannot join

  • 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;
  • Use full dose anticoagulant therapy within the past month;
  • Has experienced severe vascular disease in the past 6 months;
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  • Have experienced gastrointestinal fistula, perforation, or abdominal abscess within the past 6 months;
  • Has experienced hypertensive crisis, hypertensive encephalopathy, symptomatic heart failure (New York Class II or above), acute myocardial infarction, cerebral infarction, cerebral parenchymal hemorrhage, or other active cerebrovascular or cardiovascular diseases within the past 6 months;
  • Patients with a history of arterial aneurysm or arteriovenous malformation;
  • Having undergone major surgery within 28 days, or minor surgery or needle biopsy within 48 hours;
  • Urinary protein 3-4+, or 24-hour urinary protein quantification>1g;
  • Simultaneously accompanied by serious and uncontrolled other diseases.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hui Liu contact

02087343031

liuhui@sysucc.org.cn

Qiu Bo contact

02087343031

qiubo@sysucc.org.cn

China1 site, 1 recruiting

  • Sun yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

    Hui Liu, 02087343031, liuhui@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: Fractionated Stereotactic Radiotherapy Combines With Bevacizumab for the Treatment of Multiple Brain Metastases in Lung Adenocarcinoma: a Prospective Controlled Phase III Study

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.

Read the detailed description

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.

Patients will be randomly assigned to three groups in a ratio of 1:1:1. The FSRT+beva group receives FSRT radiotherapy+bevacizumab treatment; FSRT targets 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. 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. The FSRT group receives 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, and a fraction dose of 6Gy for segmentation. The WBRT group receives whole-brain radiotherapy (WBRT) with a simultaneous integrated boost (SIB) to visible intracranial lesions. The prescribed doses are: 40 Gy total to gross lesions and 25 Gy total to the whole brain, delivered in 10 daily fractions.

Being tested
Bevacizumab, FSRT, Whole brain radiotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabDrug

    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.

  • FSRTRadiation

    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 radiotherapyRadiation

    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.

Study groups in NCT07058428
Study groupRoleWhat they receive
The FSRT+beva groupExperimentalThe FSRT+beva group receives FSRT radiotherapy+bevacizumab treatment; FSRT targets visible intracranial lesions with a total dose of 30Gy, administered once a day for a total of 5 times, with a single dose of 6Gy. 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.
Receives: Drug: Bevacizumab; Radiation: FSRT
The FSRT groupActive comparatorThe FSRT group receives 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.
Receives: Radiation: FSRT
The WBRT groupActive comparatorThe WBRT group receive whole-brain radiotherapy (WBRT) with a simultaneous integrated boost (SIB) to visible intracranial lesions. The prescribed doses are: 40 Gy total to gross lesions and 25 Gy total to the whole brain, delivered in 10 daily fractions.
Receives: Radiation: Whole brain radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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;

    Measured: 2 years

Secondary outcomes (5)

  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

    Measured: 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

    Measured: 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).

    Measured: 2 years

  4. Treatment related side effects

    Graded according to CTCAE 5.0

    Measured: 2 years

  5. Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall (DR) failure

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2025
  2. Study start30 Jun 2025
  3. Primary completion30 Dec 2028 (estimated)
  4. Study completion30 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
258 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07058428
Sponsor's protocol ID
GASTO-10137
Status last verified
Nov 2025
First submitted
1 Jul 2025
Last updated
2 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This study is a clinical trial to ensure that patient privacy information is not disclosed.

Publications

  • Yuan X, Liu WJ, Li B, Shen ZT, Shen JS, Zhu XX. A Bayesian network meta-analysis of whole brain radiotherapy and stereotactic radiotherapy for brain metastasis. Medicine (Baltimore). 2017 Aug;96(34):e7698. doi: 10.1097/MD.0000000000007698.

    PubMed 28834873

  • Boothe D, Young R, Yamada Y, Prager A, Chan T, Beal K. Bevacizumab as a treatment for radiation necrosis of brain metastases post stereotactic radiosurgery. Neuro Oncol. 2013 Sep;15(9):1257-63. doi: 10.1093/neuonc/not085. Epub 2013 Jun 27.

    PubMed 23814264

  • Jiang T, Zhang Y, Li X, Zhao C, Chen X, Su C, Ren S, Yang N, Zhou C. EGFR-TKIs plus bevacizumab demonstrated survival benefit than EGFR-TKIs alone in patients with EGFR-mutant NSCLC and multiple brain metastases. Eur J Cancer. 2019 Nov;121:98-108. doi: 10.1016/j.ejca.2019.08.021. Epub 2019 Sep 27.

    PubMed 31569068

  • Zustovich F, Ferro A, Lombardi G, Zagonel V, Fiduccia P, Farina P. Bevacizumab as front-line treatment of brain metastases from solid tumors: a case series. Anticancer Res. 2013 Sep;33(9):4061-5.

    PubMed 24023350

  • Socinski MA, Langer CJ, Huang JE, Kolb MM, Compton P, Wang L, Akerley W. Safety of bevacizumab in patients with non-small-cell lung cancer and brain metastases. J Clin Oncol. 2009 Nov 1;27(31):5255-61. doi: 10.1200/JCO.2009.22.0616. Epub 2009 Sep 8.

    PubMed 19738122

  • Barrett OC, McDonald AM, Thompson JW, Bredel M, McGwin G, Riley KO, Fiveash JB. Distant brain recurrence in patients with five or more newly diagnosed brain metastases treated with focal stereotactic radiotherapy alone. J Radiosurg SBRT. 2017;4(4):255-263.

    PubMed 28626600

  • Aoyama H, Shirato H, Tago M, Nakagawa K, Toyoda T, Hatano K, Kenjyo M, Oya N, Hirota S, Shioura H, Kunieda E, Inomata T, Hayakawa K, Katoh N, Kobashi G. Stereotactic radiosurgery plus whole-brain radiation therapy vs stereotactic radiosurgery alone for treatment of brain metastases: a randomized controlled trial. JAMA. 2006 Jun 7;295(21):2483-91. doi: 10.1001/jama.295.21.2483.

    PubMed 16757720

  • Mekhail T, Sombeck M, Sollaccio R. Adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of one to three cerebral metastases: results of the EORTC 22952-26001 study. Curr Oncol Rep. 2011 Aug;13(4):255-8. doi: 10.1007/s11912-011-0180-1. No abstract available.

    PubMed 21584645

  • Baliga S, Garg MK, Fox J, Kalnicki S, Lasala PA, Welch MR, Tome WA, Ohri N. Fractionated stereotactic radiation therapy for brain metastases: a systematic review with tumour control probability modelling. Br J Radiol. 2017 Feb;90(1070):20160666. doi: 10.1259/bjr.20160666. Epub 2016 Dec 12.

    PubMed 27936894

  • Manning MA, Cardinale RM, Benedict SH, Kavanagh BD, Zwicker RD, Amir C, Broaddus WC. Hypofractionated stereotactic radiotherapy as an alternative to radiosurgery for the treatment of patients with brain metastases. Int J Radiat Oncol Biol Phys. 2000 Jun 1;47(3):603-8. doi: 10.1016/s0360-3016(00)00475-2.

    PubMed 10837942

  • Rades D, Janssen S, Dziggel L, Blanck O, Bajrovic A, Veninga T, Schild SE. A matched-pair study comparing whole-brain irradiation alone to radiosurgery or fractionated stereotactic radiotherapy alone in patients irradiated for up to three brain metastases. BMC Cancer. 2017 Jan 6;17(1):30. doi: 10.1186/s12885-016-2989-3.

    PubMed 28061768

  • Serizawa T, Yamamoto M, Higuchi Y, Sato Y, Shuto T, Akabane A, Jokura H, Yomo S, Nagano O, Kawagishi J, Yamanaka K. Local tumor progression treated with Gamma Knife radiosurgery: differences between patients with 2-4 versus 5-10 brain metastases based on an update of a multi-institutional prospective observational study (JLGK0901). J Neurosurg. 2019 Apr 26;132(5):1480-1489. doi: 10.3171/2019.1.JNS183085. Print 2020 May 1.

    PubMed 31026833

  • Yamamoto M, Serizawa T, Shuto T, Akabane A, Higuchi Y, Kawagishi J, Yamanaka K, Sato Y, Jokura H, Yomo S, Nagano O, Kenai H, Moriki A, Suzuki S, Kida Y, Iwai Y, Hayashi M, Onishi H, Gondo M, Sato M, Akimitsu T, Kubo K, Kikuchi Y, Shibasaki T, Goto T, Takanashi M, Mori Y, Takakura K, Saeki N, Kunieda E, Aoyama H, Momoshima S, Tsuchiya K. Stereotactic radiosurgery for patients with multiple brain metastases (JLGK0901): a multi-institutional prospective observational study. Lancet Oncol. 2014 Apr;15(4):387-95. doi: 10.1016/S1470-2045(14)70061-0. Epub 2014 Mar 10.

    PubMed 24621620

  • Chang EL, Wefel JS, Hess KR, Allen PK, Lang FF, Kornguth DG, Arbuckle RB, Swint JM, Shiu AS, Maor MH, Meyers CA. Neurocognition in patients with brain metastases treated with radiosurgery or radiosurgery plus whole-brain irradiation: a randomised controlled trial. Lancet Oncol. 2009 Nov;10(11):1037-44. doi: 10.1016/S1470-2045(09)70263-3. Epub 2009 Oct 2.

    PubMed 19801201

  • Aoyama H, Tago M, Kato N, Toyoda T, Kenjyo M, Hirota S, Shioura H, Inomata T, Kunieda E, Hayakawa K, Nakagawa K, Kobashi G, Shirato H. Neurocognitive function of patients with brain metastasis who received either whole brain radiotherapy plus stereotactic radiosurgery or radiosurgery alone. Int J Radiat Oncol Biol Phys. 2007 Aug 1;68(5):1388-95. doi: 10.1016/j.ijrobp.2007.03.048.

    PubMed 17674975

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bevacizumab, FSRT and Whole brain radiotherapy in people with Multiple Brain Metastases in Lung Adenocarcinoma, run by Sun Yat-Sen University Cancer Center at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hui Liu (02087343031, liuhui@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intracranial progression free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07058428, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.

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