Cardiac Biomarker Study in Esophageal Cancer Patients Treated With Chemotherapy and Radiation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Evaluation of Cardiac Biomarker Elevation with Radiation Therapy
研究概览
简要总结
The goal of this clinical research study is to learn if the radiation that you will receive for esophageal cancer may cause the heart to create more proteins called cardiac biomarkers.
When cardiac biomarkers are above normal levels, there may be heart damage. The relationship between cardiac biomarkers and radiation therapy has not been well studied. Learning more about this relationship may lead to better ways to check the heart during radiation therapy and predict heart problems.
详细描述
If you are found to be eligible and you agree to take part in this study, you will have baseline tests. The following tests and procedures will be performed within 1-2 weeks from the start of radiation:
- You will be asked about any other health problems you may have.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- Blood (about 1 teaspoon) will be drawn to measure cardiac biomarkers.
- You will have an electrocardiogram (ECG) to check your heart function.
- If the study doctor thinks it is needed, you will have an exam by a cardiologist (a doctor who diagnoses and treats heart problems) who will check the results of your ECG.
Study Visits:
Blood (about 1 teaspoon) will be drawn to measure cardiac biomarkers at the following time points:
- Within 12-24 hours of the start of radiation
- One (1) time during the third week of radiation
- Within 48 hours after completion of radiation
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with histologically proven esophageal cancer to be treated with RT with concurrent chemotherapy to a final dose of >/=40 Gy will be included in this study.
- •Patients with mid thoracic, distal esophageal, and gastroesophageal junction tumors.
- •All patients must sign a study-specific informed consent form. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the patient's legal representative.
- •Age >/= 18
- •Women of childbearing potential (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months [i.e., who has had menses at any time in the preceding 24 consecutive months]. For women of childbearing potential, a blood pregnancy test must be performed within 72 hours prior to the start of protocol treatment.
- •Induction chemotherapy allowed.
- •Being able to meet radiation dose constraints of at-risk organs.
排除标准
- •Patients who receive cardiotoxic drugs, such as trastuzumab or adriamycin as part of their chemotherapy regimen.
- •Patients with recent myocardial infarction in the past month, decompensated heart failure or myocarditis/pericarditis in the past month.
- •Patients with renal failure indicated by a glomerular filtration rate (GFR) < 30 mL/min/1.73sq.m.
- •Patients in the intensive care unit (ICU).
- •Patients with systemic sepsis.
- •Patients with acute pulmonary embolism in the past month.
- •Women who are pregnant or nursing are not eligible as treatment involves unforeseeable risks to the fetus or child.
- •Inability to obtain histologic proof of malignancy.
- •Patients with proximal / cervical esophageal cancer.
结局指标
主要结局
Evaluation of Cardiac Biomarker Elevation with Radiation Therapy
时间窗: Within 24 hours after first fraction of radiation therapy (RT), during 3rd week of RT (fraction 11-15), within 48 hours of RT completion (fraction 26-28).
Descriptive statistics used to summarize change from baseline in enzyme levels at each time point (beyond baseline). Each enzyme examined separately. Pearson or Spearman correlation coefficient used to examine correlation between changes in cardiac biomarkers from baseline in enzyme level at each time point and mean radiotherapy dose or cumulative dose to heart. Linear mixed effects regression model used to model longitudinal change in cardiac biomarker from baseline as a function of cumulative radiation to the heart, radiation modality (Protons vs Photons), and time.
次要结局
- Incidence of Adverse Cardiac Outcomes(Within 24 hours after first fraction of radiation therapy (RT), during 3rd week of RT (fraction 11-15), within 48 hours of RT completion (fraction 26-28).)