Brain Metastasis, MRI-guided Adaptive Radiotherapy, Non-small Cell Lung Cancer
Conditions
Keywords
MRI-guided radiotherapy, lung cancer, brain metastasis
Brief 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.
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.
Interventions
RADIATIONMRI-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.
RADIATIONConventional SRT
Conventional SRT (with PTV expansion margin). The total dose will be 30Gy/5 fractions, administered once daily. CBCT will be acquired.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiation-related brain necrosis incidence rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intracranial progression-free survival rate | 1 year | The percentage of patients who, after one year of treatment, have not experienced any progression of their intracranial disease. |
| Objective response rate | 1-year | To evaluate the effectiveness of a treatment for brain tumors based on RECIST 1.1 criteria. |
| Overall survival | 1 year | The percentage of patients who are alive after one year of treatment. |
| Radiation-related Neurotoxicity | 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. |
Countries
China
Contacts
Primary ContactHui Liu
Backup ContactDaQuan Wang
Outcome results
None listed