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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Small cell carcinoma of lung

Intracranial metastases needed surgical decompression

Patients with contraindications for MRI

Previous radiotherapy or excision for intracranial metastases

Trial design

Design model

Parallel

Treatments tested in this trial

  • MRI-guided adaptive SRT

    Radiation

    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 SRT

    Radiation

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

Treatment groups

168 Participants
are divided into 2 treatment groups
Group A: The study groupExperimental treatment 1 intervention
Group B: The control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
1 year

Secondary outcomes

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.

Time frame
1 year
2

Objective response rate

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

Time frame
1-year
3

Overall survival

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

Time frame
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.

Time frame
1 year

Other outcomes

Sponsors and contacts

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