FDG-PET-CT and Biomarkers to Assess Pathologic Response in Surgical Specimens of Patients With Localized Esophageal Cancer After Chemoradiation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Pathologic Response
研究概览
简要总结
The goal of this clinical research study is to learn if the results of a positron emission tomography/computed tomography (PET/CT) scan done 10-14 days after beginning chemotherapy and radiation (chemoradiation) can predict how a patient with cancer of the esophagus will respond to chemoradiation. Researchers also want to learn if biomarkers (substances in the body associated with cancer) found in tumor tissue can predict response to chemoradiation.
详细描述
You have cancer of the esophagus and you and your doctor have agreed that you will have treatment with chemoradiation to try to shrink the cancer. You will then have surgery to remove any remaining tumor.
How well cancer of the esophagus responds to chemoradiation varies from person to person. Currently, doctors cannot tell before surgery in which patients the chemoradiation will kill all of the cancer, some of the cancer, or not much of the cancer. Studying patients' PET/CT scans and tumor tissue for biomarkers may help researchers predict how an individual patient will respond to chemoradiation. This could spare future patients from having unnecessary surgery or chemoradiation treatment that is not effective.
PET and CT scans are both standard imaging tests that doctors use to find cancer in the body. The PET scan detects the signal of actively growing cancer cells in the body and the CT scan shows the location, size, and shape of the cancer. Combining these scans provides more complete information on cancer location, growth, and changes in the cancer over time.
Currently, routine testing for esophageal cancer at MD Anderson includes a PET/CT scan at the time of diagnosis and 5 or 6 weeks after chemoradiation is completed. Researchers hope that analyzing changes seen in an "early" PET/CT scan (performed between 10-14 days after starting chemoradiation) compared to the PET/CT scan taken at the time of diagnosis may predict how well the chemoradiation will work against the patient's cancer.
PET/CT Scan:
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
- •Patient must have histologic documentation of adenocarcinoma or squamous carcinoma of the esophagus at M. D. Anderson Cancer Center (MDACC).
- •Patients with localized carcinoma of the esophagus who have undergone standard testing and been evaluated by the multidisciplinary team at MDACC and are considered appropriate candidates for and are willing to undergo chemoradiation therapy followed by surgery at MDACC. Radiation may be delivered as proton or photon. These patients have clinical stage II or III cancers and they are considered medically fit to undergo surgery.
- •Patient must have undergone a baseline esophagealgastroduodenoscopy (EGD) with biopsy and endoscopic ultrasonography at MDACC, with tissue available for biomarker analysis.
- •Patient must have undergone a baseline FDG-PET/CT at MDACC or an outside institution.
- •Patient must be willing to undergo a research "early" FDG-PET/CT (12 +/- 2 days from the start of chemoradiation).
- •Patient must provide written informed consent.
- •Patient must be >/= 18 years of age.
排除标准
- •Patient is unable or unwilling to comply with the requirements of the protocol.
- •Patient had baseline FDG-PET/CT scan maximum SUV of < 4.
- •Patient is not a candidate for chemoradiation followed by surgery.
- •Patients who received induction chemotherapy prior to chemoradiation therapy are excluded.
- •Patients with T1N0 or T4anyN are excluded.
结局指标
主要结局
Pathologic Response
时间窗: PET-CT at 12 + 2 days after the start of chemoradiation
From baseline PET-CT to "early" PET-CT \[12 + 2 days after the start of chemoradiation\] Frequency and percentage of pathologic complete response (pathCR) and extreme chemoradiation resistance (exCRTR) patients tabulated. Exploratory graphics, such as box plots, used to illustrate distribution of PET/CT maximum SUV by pathCR (or exCRTR) status. A logistic regression model fit for pathCR (and separately, for exCRTR), with baseline and the change of maximum SUV between baseline and early chemoradiation included as covariates.
次要结局
未报告次要终点