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

November 14, 2025 updated by: Hui Liu, Sun Yat-sen University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

168

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun yat-sen University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The study group
Patients 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.
Radiation: MRI-guided adaptive SRT
MRI-guided online adaptive SRT (without PTV expansion margin). The total dose will be 30Gy/5 fractions, administered once daily. MRI will be acquired.
Active Comparator: The control group
Patients 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.
Radiation: Conventional SRT
Conventional SRT (with PTV expansion margin). The total dose will be 30Gy/5 fractions, administered once daily. CBCT will be acquired.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation-related brain necrosis incidence rate
Time Frame: 1 year
"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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intracranial progression-free survival rate
Time Frame: 1 year
The percentage of patients who, after one year of treatment, have not experienced any progression of their intracranial disease.
1 year
Objective response rate
Time Frame: 1-year
To evaluate the effectiveness of a treatment for brain tumors based on RECIST 1.1 criteria.
1-year
Overall survival
Time Frame: 1 year
The percentage of patients who are alive after one year of treatment.
1 year
Radiation-related Neurotoxicity
Time Frame: 1 year
"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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

August 28, 2024

First Submitted That Met QC Criteria

August 31, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GASTO-10115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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