Brain Metastases Clinical Trial
Official title:
Elective Simultaneous Modulated Accelerated Brain Radiation Therapy for NSCLCs With Limited Brain Metastases,A Phase I,One-arm Trial
Brain metastases are the most common intracranial tumors in adults. Whole-brain radiation therapy (WBI) increases the median survival of patients with brain metastases up to 3-6 months, but WBI can lead to the decline of cognition and quality of life, with short local control time. The use of SIB(simultaneous integrated boost) technology can increase the local control rate. Hippocampus avoidance can effectively reduce the cognitive impairment caused by WBI.This study was designed to evaluate the safety and efficacy of selective brain radiotherapy (EBI)(based on SIB and hippocampus, inner ear avoidance )in NSCLCs with limited brain metastases.
In this prospective phase 1 study evaluating the safety and efficacy of selective brain
radiotherapy in NSCLCs with limited brain metastases, patients will received selective brain
radiotherapy based on SIB and hippocampus, inner ear avoidance.
Prescription dose: Gross tumor (PGTV) 40-50 Gy/10 fractions/2 weeks + EBI (PCTV) 30 Gy/10
fractions/2 weeks.
OARs dose limits: Hippocampus D100%≤10Gy, Dmax≤17Gy,Inner ear: Dmean ≤15Gy. All patients were
observed and recorded daily for acute radiation impairment during radiotherapy. Follow-up
every 2 months will be performed after radiotherapy.
The primary endpoint:Acute and chronic radiation response, QOL in patients, vestibular
function,neurocognitive function based on mini-mental state examination(MMSE) questionnaires,
hearing.
The secondary endpoint included:objective response rate (ORR);intracranial progression-free
survival (iPFS); OS (defined as the time from study beginning to death from any cause).
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