Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
ID06582940

Elimination of PTV Margins Using MRI-guided Adaptive Stereotactic Radiotherapy for Non-small Cell Lung Cancer Patients with Brain Metastasis

Led by Sun Yat-sen University · Updated on 2025-11-17

168

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and efficacy of removing planning target volume (PTV) margins using MRI-guided adaptive stereotactic radiotherapy (SRT) in patients with non-small cell lung cancer (NSCLC) who have brain metastases. The study compares this MRI-guided approach to conventional CT-guided stereotactic radiotherapy that includes PTV expansion margins. This phase 2 trial aims to determine if eliminating PTV margins can maintain treatment safety and effectiveness. Participants will be randomly assigned to one of two groups. The study group will receive MRI-guided adaptive SRT without PTV expansion margin, delivered once daily for five sessions with a total dose of 30Gy using an MRI-linac. The control group will receive conventional standard SRT with PTV expansion margin, also given once daily for five sessions with a total dose of 30Gy, delivered using a conventional linear accelerator. After treatment completion, patients will have regular follow-up visits to monitor outcomes. During the study, participants will undergo MRI or CT scans depending on their group, as well as evaluations of brain necrosis incidence, intracranial progression, tumor response, overall survival, and radiation-related neurotoxicity over one year. Organ and bone marrow functions will be monitored before treatment. The total participation duration includes treatment followed by systematic safety and efficacy assessments extending to one year after therapy.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 75 years
  • Histologically or cytologically confirmed non-small cell lung cancer
  • 1 to 10 brain metastases visible on contrast-enhanced MRI
  • Radiotherapy allowed for extracranial lesions
  • Tyrosine kinase inhibitors permitted for intracranial metastases progression during prior therapy
  • Measurable or evaluable lesions based on RECIST criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Normal organ and bone marrow function within 14 days, including specific lab value limits
  • Informed consent provided
Not Eligible

You will not qualify if you...

  • Small cell carcinoma of the lung
  • Brain metastases requiring surgical decompression
  • Contraindications for MRI
  • Prior radiotherapy or surgery for brain metastases
  • Recent severe cardiovascular or cerebrovascular events
  • Uncontrolled hypertension (systolic > 150 mmHg or diastolic > 100 mmHg)
  • Major surgery within 28 days or minor surgery/biopsy within 48 hours
  • Significant proteinuria (urine protein 3-4+ or >1g/24h)
  • Severe uncontrolled diseases
  • Uncontrollable seizures or psychosis without self-control
  • Pregnancy or breastfeeding
  • Other conditions deemed unsuitable by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 5 days

Participants receive either MRI-guided adaptive stereotactic radiotherapy without PTV expansion margin or conventional stereotactic radiotherapy with PTV expansion margin. The total radiation dose is 30Gy delivered in 5 daily fractions.

5 daily visits (in-person)

Follow-up

Duration - Up to 1 year

Participants are followed up regularly after treatment to assess safety and efficacy, including monitoring for radiation-related brain necrosis, intracranial progression, response rate, overall survival, and neurotoxicity.

Regular follow-up visits over 1 year

Trial Site Locations

Total: 1 location

1

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

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Research Team

H

Hui Liu

D

DaQuan Wang

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Fractionated stereotactic radiation therapy for brain metastases: a systematic review with tumour control probability modelling.

Sujith Baliga, Madhur K Garg, Jana Fox...

https://pubmed.ncbi.nlm.nih.gov/27936894

Hypofractionated stereotactic radiotherapy with or without whole-brain radiotherapy for patients with newly diagnosed brain metastases from non-small cell lung cancer.

Liang-Hua Ma, Guang Li, Hong-Wei Zhang...

https://pubmed.ncbi.nlm.nih.gov/23205789

First patients treated with a 1.5 T MRI-Linac: clinical proof of concept of a high-precision, high-field MRI guided radiotherapy treatment.

B W Raaymakers, I M Jürgenliemk-Schulz, G H Bol...

https://pubmed.ncbi.nlm.nih.gov/29135471