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MRI-guided Adaptive RadiotherapyPhase 2NCT06582940

Elimination of PTV Margins Based on MRI-guided Adaptive Stereotactic Radiotherapy for Non-small Cell Lung Cancer With Brain Metastasis

A Phase 2 study testing MRI-guided adaptive SRT and Conventional SRT in people with MRI-guided Adaptive Radiotherapy and Non-small Cell Lung Cancer, run by Sun Yat-sen University 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
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Trial summary

This study aims to explore the safety and efficacy of eliminating the planning target volume (PTV) margins based on MRI-guided adaptive stereotactic radiotherapy for non-small cell lung cancer (NSCLC) patients with brain metastasis. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
MRI-guided adaptive SRT and Conventional SRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
1 siteChina
Study dates
1 Mar 2024to 1 Mar 2026
Phase
Phase 2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18-75 years
  • Histologically or cytologically confirmed non-small cell lung cancer
  • 1-10 metastases on contrast-enhanced MRI
  • Radiotherapy for extracranial lesions is permitted
  • Tyrosine kinase inhibitors (TKI) are permitted in patients with progression of
  • intracranial metastases during previous TKI therapy
Show all 10Show fewer
  • Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Normal function of organs and bone marrow within 14 days: Total bilirubin 1.5 times or less the upper limits of normal (ULN); AST and ALT 1.5 times or less the ULN; absolute neutrophil count≥ 500 cells/mm3; creatinine clearance rate(CCR) ≥45 mL/min; Platelet count≥50,000 cells/mm3; international normalized ratio(INR) ≤1.5#Prothrombin Time (PT)≤ 1.5 × ULN
  • Informed-consent

Who cannot join

  • Small cell carcinoma of lung
  • Intracranial metastases needed surgical decompression
  • Patients with contraindications for MRI
  • Previous radiotherapy or excision for intracranial metastases
  • Hypertensive crisis, hypertensive encephalopathy, symptomatic heart failure (New York class II or above), active cerebrovascular disease or cardiovascular disease occurred within 6 months
  • Uncontrolled hypertension (systolic > 150mmHg and/or diastolic > 100mmHg)
Show all 12Show fewer
  • Major surgery within 28 days or minor surgery or needle biopsy within 48 hours
  • Urine protein 3-4+, or 24h urine protein quantitative >1g
  • Severe uncontrolled disease
  • Uncontrollable seizure or psychotic patients without self-control ability
  • Women in pregnancy, lactation period
  • Other not suitable conditions determined by the investigators

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

13661150862

liuhuisysucc@126.com

DaQuan Wang contact

13661150862

wangdq@sysucc.org.cn

China1 site, 1 recruiting

  • Sun yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Hui Liu, MD, +86-020-87343031, liuhuisysucc@126.com

    Recruiting

Other trials in China

About this study

This study aims to explore the safety and efficacy of eliminating the planning target volume (PTV) margins based on MRI-guided adaptive stereotactic radiotherapy for non-small cell lung cancer (NSCLC) patients with brain metastasis.

Read the detailed description

This study aims to explore the safety and efficacy of eliminating the planning target volume (PTV) margins based on MRI-guided adaptive stereotactic radiotherapy for NSCLC patients with brain metastasis. In this study, patients will be randomly assigned in a 1:1 ratio to the study group or the control group. Patients in the study group will receive MRI-guided adaptive stereotactic radiotherapy (SRT) (without PTV expansion margin), while patients in the control group will receive CT-guided conventional standard SRT (with PTV expansion margin). After the completion of treatment, patients will be followed up regularly to assess safety and efficacy.

Being tested
MRI-guided adaptive SRT, Conventional SRT
Keywords
MRI-guided radiotherapy, lung cancer, brain metastasis
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Brain Neoplasms, Lung Neoplasms

What participants receive

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

  • MRI-guided adaptive SRTRadiation

    MRI-guided online adaptive SRT (without PTV expansion margin). The total dose will be 30Gy/5 fractions, administered once daily. MRI will be acquired.

  • Conventional SRTRadiation

    Conventional SRT (with PTV expansion margin). The total dose will be 30Gy/5 fractions, administered once daily. CBCT will be acquired.

Study groups in NCT06582940
Study groupRoleWhat they receive
The study groupExperimentalPatients in the study group will receive MRI-guided adaptive stereotactic radiotherapy (without PTV expansion margin). The total dose will be 30Gy/5 fractions, administered once daily. The MRI-linac is used for the delivery of radiotherapy.
Receives: Radiation: MRI-guided adaptive SRT
The control groupActive comparatorPatients in the study group will receive conventional standard stereotactic radiotherapy (with PTV expansion margin). The total dose will be 30Gy/5 fractions, administered once daily. The conventional linac is used for the delivery of radiotherapy.
Receives: Radiation: Conventional SRT

What is being measured

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

  1. Radiation-related brain necrosis incidence rate

    "Radiation-related brain necrosis" refers to brain tissue damage that occurs as a result of radiation therapy. It can be detected by brain MRI imaging.

    Measured: 1 year

Secondary outcomes (4)

  1. intracranial progression-free survival rate

    The percentage of patients who, after one year of treatment, have not experienced any progression of their intracranial disease.

    Measured: 1 year

  2. Objective response rate

    To evaluate the effectiveness of a treatment for brain tumors based on RECIST 1.1 criteria.

    Measured: 1-year

  3. Overall survival

    The percentage of patients who are alive after one year of treatment.

    Measured: 1 year

  4. Radiation-related Neurotoxicity

    "Neurotoxicity" refers to the harmful effects that certain substances or conditions can have on the nervous system, which was examined based on RECIST 1.1 criteria.

    Measured: 1 year

Timeline

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

  1. First posted3 Sep 2024
  2. Study start1 Mar 2024
  3. Primary completion1 Mar 2026 (estimated)
  4. Study completion1 Mar 2026 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
168 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06582940
Sponsor's protocol ID
GASTO-10115
Status last verified
Nov 2025
First submitted
28 Aug 2024
Last updated
17 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shaw MG, Ball DL. Treatment of brain metastases in lung cancer: strategies to avoid/reduce late complications of whole brain radiation therapy. Curr Treat Options Oncol. 2013 Dec;14(4):553-67. doi: 10.1007/s11864-013-0258-0.

    PubMed 24048959

  • 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

  • Lagendijk JJ, Raaymakers BW, Van den Berg CA, Moerland MA, Philippens ME, van Vulpen M. MR guidance in radiotherapy. Phys Med Biol. 2014 Nov 7;59(21):R349-69. doi: 10.1088/0031-9155/59/21/R349. Epub 2014 Oct 16. No abstract available.

    PubMed 25322150

  • Khoo VS, Joon DL. New developments in MRI for target volume delineation in radiotherapy. Br J Radiol. 2006 Sep;79 Spec No 1:S2-15. doi: 10.1259/bjr/41321492.

    PubMed 16980682

  • Stemkens B, Tijssen RHN, de Senneville BD, Lagendijk JJW, van den Berg CAT. Image-driven, model-based 3D abdominal motion estimation for MR-guided radiotherapy. Phys Med Biol. 2016 Jul 21;61(14):5335-55. doi: 10.1088/0031-9155/61/14/5335. Epub 2016 Jun 30.

    PubMed 27362636

  • Glitzner M, Crijns SP, de Senneville BD, Kontaxis C, Prins FM, Lagendijk JJ, Raaymakers BW. On-line MR imaging for dose validation of abdominal radiotherapy. Phys Med Biol. 2015 Nov 21;60(22):8869-83. doi: 10.1088/0031-9155/60/22/8869. Epub 2015 Nov 4.

    PubMed 26531846

  • Ma LH, Li G, Zhang HW, Wang ZY, Dang J, Zhang S, Yao L, Zhang XM. Hypofractionated stereotactic radiotherapy with or without whole-brain radiotherapy for patients with newly diagnosed brain metastases from non-small cell lung cancer. J Neurosurg. 2012 Dec;117 Suppl:49-56. doi: 10.3171/2012.7.GKS121071.

    PubMed 23205789

  • Raaymakers BW, Jurgenliemk-Schulz IM, Bol GH, Glitzner M, Kotte ANTJ, van Asselen B, de Boer JCJ, Bluemink JJ, Hackett SL, Moerland MA, Woodings SJ, Wolthaus JWH, van Zijp HM, Philippens MEP, Tijssen R, Kok JGM, de Groot-van Breugel EN, Kiekebosch I, Meijers LTC, Nomden CN, Sikkes GG, Doornaert PAH, Eppinga WSC, Kasperts N, Kerkmeijer LGW, Tersteeg JHA, Brown KJ, Pais B, Woodhead P, Lagendijk JJW. First patients treated with a 1.5 T MRI-Linac: clinical proof of concept of a high-precision, high-field MRI guided radiotherapy treatment. Phys Med Biol. 2017 Nov 14;62(23):L41-L50. doi: 10.1088/1361-6560/aa9517.

    PubMed 29135471

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MRI-guided adaptive SRT and Conventional SRT in people with MRI-guided Adaptive Radiotherapy and Non-small Cell Lung Cancer, run by Sun Yat-sen University 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 10 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 17 Nov 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 (13661150862, liuhuisysucc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiation-related brain necrosis incidence rate (time frame: 1 year). 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 NCT06582940, which also lists 8 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 17 Nov 2025.

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