Clinical Trial: Neurocognitive Function After Prophylactic Cranial Irradiation & Hippocampal Sparing in LD SCLC Patients - a Pilot Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Neurocognitive Function Changes in Patients With LD Small Cell Lung Cancer Undergoing Prophylactic Whole Brain Radiotherapy With Hippocampal Sparing - a Pilot Study
Brief Summary: Small cell lung cancer (SCLC) harbors a high risk for brain metastases. Prophylactic whole brain radiotherapy (PCI)) is the standard treatment for these patients after completing chemo-radiotherapy to the chest, with a 5% survival advantage. Recent data suggest minimal risk for hippocampal involvement in these patients. There is no published data thus far testing the effect of hippocampal sparing during WBRT on the patient's neuro-cognitive function, QOL, and survival.., The goals of the proposed study are to assess prospectively the neurocognitive changes in patients with LD SCLC who are candidates for PCI before, and periodically after PCI
Detailed Summary:
Background and rational Prophylactic cranial irradiation Small cell lung cancer (SCLC) is an aggressive type of lung cancer, with high sensitivity to chemotherapy and radiotherapy but with high incidence of local and distant recurrences. The brain is a common site of metastases from SCLC with a risk of up to 70% for brain involvement [1]. Prophylactic cranial irradiation (PCI) is the standard treatment for patients with limited disease (LD) SCLC after completing chemo-radiotherapy to the chest. The treatment includes whole brain radiotherapy (WBRT), reduces the incidence of brain metastases and improves overall survival (OS) by 5% [1]. The down side of WBRT is that the central nervous system (CNS) is vulnerable to radiotherapy (RT) and its related toxicity may be associated with irreversible cognitive dysfunction [2].
Radiotherapy and neuro-cognitive function It has been demonstrated that there are two main regions of human containing multipotent neural stem cells (NSCs): the subgranular zone (SGZ) within the dentate gyrus of the hippocampus, and the subventricular zone (SVZ) on the lateral aspect of the lateral ventricles [3,4,5,6,7,8]. These NSCs are capable of replacing adult neuron loss caused by various forms of harm (e.g. local ischemia, brain trauma, and radiation exposure and neurodegenerative diseases). However, they are extremely sensitive to X-rays, and thus reduction of NSCs may play an important role in radiation-induced neurocognitive impairment [6,7,8]. Neurocognitive function (NCF) has a major impact on QOL and has been actively studied in brain tumor patients treated with radiotherapy. Many studies have evaluated the neurocognitive outcome of patients treated with radiation for brain metastases and primary brain tumors [9,10,11,12,13,14]. Radiation primarily causes coagulation necrosis of the white matter tracts and cerebral vasculature by axonal demyelin
Sponsor: Sheba Medical Center
Current Primary Outcome: Number of patients that complete a year of imaging, neuro-cognitive and clinical follow up after WBRT with HC sparing as a measure of feasibility to conduct a randomized study in this patient population. [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of patients with no changes in the neurocognitive tests score and QOL as a measure for the correlation between NCT and HC sparing. [ Time Frame: 1 year ]
- Number of patients with no changes in serum markers for neuronal damage and as a measure for reduced damage due to hippocampal sparing [ Time Frame: 1 year ]
- Number of patients with changes in imaging biomarkers (TRAM) and neurocognitive tests score decline as a measure for a potential correlation between the two. [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: Sheba Medical Center
Dates:
Date Received: January 29, 2015
Date Started: January 2015
Date Completion: January 2017
Last Updated: April 18, 2016
Last Verified: April 2016
