The Utility of Positron Emission Tomography (PET) in Staging of Patients With Potentially Operable Carcinoma of the Thoracic Esophagus

Alliance for Clinical Trials in Oncology35 个研究点分布在 1 个国家目标入组 235 人开始时间: 1999年11月最近更新: 2017年1月24日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Alliance for Clinical Trials in Oncology
入组人数: 235
试验地点: 35
主要终点: Proportion of these patients with FDG-PET findings that contraindicate surgery

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

RATIONALE: Imaging procedures such as positron emission tomography may improve the ability to determine the stage of esophageal cancer.

PURPOSE: This clinical trial is studying how well fludeoxyglucose F 18 positron emission tomography determines tumor stage in patients with esophageal cancer.

详细描述

OBJECTIVES:

Primary Objective:

To evaluate whether FDG-PET imaging can detect lesions that would preclude surgery (esophagectomy) in patients found to be surgical candidates by standard imaging procedures.

Secondary Objective:

To use the collected data to generate hypotheses to be used in future studies, such as which types of previously undetected lesions FDG-PET imaging is best able to identify.

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 be ≥ 18 years of age.
•Patient must have histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (greater than or equal to 20 cm from incisors) or gastroesophageal junction. (Pathology report must be submitted).
•Patient must be deemed medically fit for surgical staging procedures and esophagectomy following the thoracic surgeon's evaluation of general medical fitness.
•Patient's clinical staging data (clinical examination, laboratory tests, and standard radiological staging assessments) must be obtained within 60 days prior to registration and must suggest that the tumor is potentially resectable, including tumors staged T1-3, N0-1, M
•Patient must be able to tolerate FDG-PET scan (e.g., not claustrophobic and able to lie supine for 1.5 hrs).
•Female patient of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to FDG-PET.
•NOTE: Pregnancy test is required to avoid unnecessary fetal radiation exposure and because the use of furosemide is contraindicated in pregnancy.
•Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study related procedures.
•Patient must provide written authorization to allow the use and disclosure of their protected health information.
•NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study pre-registration.
•A cancer survivor is eligible provided that ALL of the following criteria are met and documented:
•the patient has undergone potentially curative therapy for all prior malignancies and
•there has been no evidence of any prior malignancies for at least five years (except for completely resected cervical or non-melanoma skin cancer) and
•the patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.

排除标准

•Patient has proximal esophageal cancer (less than 20 cm from incisors) potentially requiring pharyngolaryngoesophagectomy.
•Patient has unresectable lesions (stage M1b, with biopsy confirmation of distant metastatic disease; or those with unresectable locoregional invasion, T4 Nx Mx).
•Patient has evidence of metastatic disease.
•NOTE: Obvious metastasis that is based on clinical evaluation includes any or all of the following: positive cytology of pleura, pericardium, or peritoneum; metastasis to brain, bone, lung, liver, or adrenals; positive biopsy or cytology of metastasis to supraclavicular lymph nodes; and involvement of the tracheobronchial tree (positive bronchoscopic biopsy or overt esophago-respiratory fistula).
•Patient has had a prior FDG-PET scan for evaluation of their esophageal cancer.
•Patient has uncontrolled diabetes mellitus, as evidenced by a fasting blood glucose value >200 mg/dL, within 12 hours of FDG-PET scan.
•Patient has received neoadjuvant chemotherapy and/or radiotherapy PRIOR to FDG-PET scan being performed.

研究组 & 干预措施

FDG-PET scan +/- neoadjuvant chemotherapy + surgery

Experimental

Patients receive fludeoxyglucose F 18 (FDG) IV followed 45-60 minutes later by positron emission tomography (PET) imaging. Confirmatory studies, such as biopsy or other imaging studies, are then conducted to confirm the FDG PET imaging results. Patients with no metastases identified by FDG PET imaging may undergo esophagectomy with or without neoadjuvant chemoradiotherapy within 1 month of evaluation.