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

Launched by SUN YAT-SEN UNIVERSITY · Aug 31, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new approach to treating non-small cell lung cancer (NSCLC) that has spread to the brain. Specifically, it aims to find out if it is safe and effective to use MRI scans to adjust radiation therapy without the usual safety margins that are typically included in treatment planning. By doing this, researchers hope to improve the precision of the treatment while still ensuring it's safe for patients.

To be eligible for this study, participants should be between 18 and 75 years old and have a confirmed diagnosis of NSCLC with 1 to 10 brain metastases visible on an MRI scan. They can also be receiving treatment for other cancers outside of the brain. Participants will receive regular check-ups and monitoring throughout the trial to assess their health and the effectiveness of the treatment. It's important to note that certain health conditions or recent surgeries may prevent someone from participating. This trial is currently recruiting participants, and those interested should talk to their doctor for more details.

Gender

ALL

Eligibility criteria

• 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