At a glance
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Nitroglycerin Plus Whole Intracranial Radiotherapy for Brain Metastases in Non-small Cell Lung Cancer Patients: a Phase II Open Randomized Clinical Trial
In Brief
A Phase 2 clinical trial evaluating Whole-brain radiotherapy for Phase II Clinical Trial and 3 related conditions. Completed, enrolled 96 participants across 1 site.
Detailed Summary
Background: Whole-brain radiotherapy (WBRT) is the standard treatment for multiple brain metastases (BM), in NSCLC patients who are not candidates for treatment with stereotactic radiation body therapy. Hypoxia has been associated with chemo-radioresistance secondary to Vascular Endothelial Growth Factor Receptor (VEGFR) induced by Hypoxia Induced Factor (HIF). Nitroglycerin (NTG) can reduce HIF-1 alfa in tissues, and this may have anti-angiogenic, pro-apoptotic and anti-efflux effects. In this phase II study, we evaluated the effect of transdermal nitroglycerin (TN) on intracranial progression-free survival (ICPFS), objective response rate (ORR) and overall survival (OS) of NSCLC patients with BM. Material and methods: We performed an open-label, phase II clinical trial among ninety-six histologically confirmed NSCLC patients with BM. Patients were randomized 1:1 to receive NTG plus WBRT or WBRT alone. ORR and ICPFS were evaluated by MRI by two independent, blinded radio-oncologists.
Study Details
Timeline
Interventions
Patients were randomized 1:1 and allocated to either the control arm who received whole-brain radiotherapy (WBRT) or the experimental arm who received WBRT and the addition 36 mg of transdermal nitroglycerin (TN)