This study evaluates hippocampus-sparing whole-brain radiotherapy with simultaneous integrated boost for patients with multiple brain metastases from non-small cell lung cancer. The primary endpoint is intracranial progression free survival, and secondary endpoints are verbal neurocognitive function, overall survival, adverse events according to CTCAE v4.03, and quality of life.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Radiotherapy could be delivered in 5, 8, or 10 fractions according to participating investigator's choice. The prescribed doses are as below; Fractions 5fxs 8fxs 10fxs Whole brain 20 Gy 24 Gy 25 Gy Gross tumor 30 Gy 40 Gy 40 Gy
Samsung Medical Center
Seoul, South Korea
RECRUITINGIntracranial progression free survival
Time from the date of start of radiotherapy to the date of death or intracranial progression
Time frame: until 12 months
Verbal neurocognitive function (Seoul Verbal Learning Test-Elderly, SVLT-E)
The relative decline in SVLT-E score from baseline to below time frame; ΔSVLT = (SVLTB - SVLTF) ÷ SVLTB, where B=baseline and F=follow-up.
Time frame: 3,6,12 months
Overall survival
Time from the date of start of radiotherapy to the date of death from any cause
Time frame: until 12 months
Adverse events
CTCAE v4.03
Time frame: 3,6,12 months
Quality of life
EORTC QLQ-C30 and BN20
Time frame: 3,6,12 months
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