Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance in Non-Squamous Locally Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Central Nervous System Symptoms - Central Nervous System Symptom Scoring Form
研究概览
简要总结
The purpose of this research is to see if monitoring the brain using magnetic resonance imaging (MRI) after radiation therapy will allow investigators to find cancer that has spread to the brain (brain metastases) before it causes symptoms.
详细描述
Primary Objective: To evaluate whether additional follow up brain MRI in patients with non-squamous stage III nonsmall cell lung cancer who were previously treated with curative intent radiation therapy reduces the rate of symptomatic brain metastasis presentation as compared to historical controls.
Secondary Objectives:
- To estimate time to brain failure in patients with non-squamous stage III nonsmall cell lung cancer previously treated with curative intent radiation therapy who undergo additional surveillance brain magnetic resonance imaging.
- To describe documented brain metastasis(es) characteristics in patients with non-squamous stage III nonsmall cell lung cancer previously treated with curative intent radiation therapy who undergo additional surveillance brain magnetic resonance imaging.
OUTLINE:
Patients undergo MRI with or without gadolinium contrast intravenously (IV) as well as blood sample collection on study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years of age.
- •Patients with non-squamous locally advanced lung cancer defined by American Joint Committee on Cancer (AJCC) version 8 stage IIIA, IIIB, or IIIC disease.
- •Histology described as adeno-squamous or not otherwise specified favoring squamous are eligible.
- •Patients may be enrolled before or after the start of radiation therapy but must be enrolled and have their first surveillance MRI brain at 120 +/- 10 days of their first treatment of radiation therapy for their locally advanced lung cancer. The first radiation treatment is defined as day
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 -
- •Epidermal growth factor receptor (EGFR) > 30 mL/min/1.73m
- •Patients must be eligible for a brain MRI per the Wake Forest MRI safety screening checklist questionnaire. This will be completed by a MRI imaging technician, enrolling physician, CPDM staff member, a magnetic resonance safety officer, and/or a radiologist as indicated in the form.
排除标准
- •Known brain metastases on staging MRI.
- •Questionable findings that may represent a differential of vasculature abnormalities/stroke/ and or metastatic disease with recommended short interval follow-up are not an exclusion factor for study participation. The recommended follow-up imaging for such findings should have no bearing on the imaging schedule in this protocol, and this research protocol imaging should NOT serve as an official follow-up scan for such findings.
- •Patients who are pregnant or breastfeeding.
- •Premenopausal persons of childbearing potential must have a negative pregnancy test within 14 days of enrollment. If women are not of childbearing potential as defined by women who are menopausal female or has had a hysterectomy, bilateral oophorectomy, or medically-documented ovarian failure, they will not require a pregnancy test. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
研究组 & 干预措施
Surveillance MRI of the Brain
Brain MRI will be performed as scheduled for up to 14 months or until detection of a brain metastasis, whichever occurs first.
干预措施: Blood draws (Other)
Surveillance MRI of the Brain
Brain MRI will be performed as scheduled for up to 14 months or until detection of a brain metastasis, whichever occurs first.
干预措施: MRI of the Brain (Diagnostic Test)
Surveillance MRI of the Brain
Brain MRI will be performed as scheduled for up to 14 months or until detection of a brain metastasis, whichever occurs first.
干预措施: Quality of Life Questionnaires (Other)
Surveillance MRI of the Brain
Brain MRI will be performed as scheduled for up to 14 months or until detection of a brain metastasis, whichever occurs first.
干预措施: Gadolinium (Drug)
结局指标
主要结局
Change in Central Nervous System Symptoms - Central Nervous System Symptom Scoring Form
时间窗: At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment
Symptomatic brain metastasis presentation (yes or no) will be determined for each participant. Symptomatic brain metastasis presentation anytime during follow-up will be considered a YES. Asymptomatic presentation and death during follow-up without symptomatic presentation will be considered a NO. Patients with incomplete follow-up for reasons other than death will be excluded from the analysis. The proportion with symptomatic presentation will be calculated, and compared to the historical rate of 24% using a one-sample proportion test. A symptomatic brain metastasis presentation is defined as imaging demonstrating evidence of brain metastasis(es) and a change in any given central nervous system symptom. Questions require a YES or NO answer related to symptoms. Questions that are answered YES more often would indicate a unfavorable change in central nervous system symptoms
次要结局
- Collection of Information to Document Brain Metastasis(es) - Number of Metastases(At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment)
- Collection of Information to Document Brain Metastasis(es) - Volume of Metastases(At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment)
- Time to Brain Failure(At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment)
- Collection of Information to Document Brain Metastasis(es) - Size of Metastases(At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment)