NL-OMON50293已完成不适用
Preoperative Image-guided Identification of Response to Neoadjuvant Chemoradiotherapy in Esophageal cancer - PRIDE study
niversitair Medisch Centrum Utrecht0 个研究点目标入组 200 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Histologically confirmed squamous cell carcinoma or adenocarcinoma of the
- •esophagus or gastroesophageal junction (i.e. tumors involving both cardia and
- •esophagus on endoscopy)
- •Potentially resectable locally advanced esophageal tumor (cT1b-4a N0-3 M0):
- •based on standard primary staging by EUS and 18F-FDG PET-CT
- •Scheduled to receive neoadjuvant chemoradiotherapy according to the
- •CROSS-regimen: weekly administration of carboplatin and paclitaxel for 5 weeks
- •and concurrent radiotherapy (41.4Gy in 23 fractions, 5 days per week) followed
- •by esophagectomy
- •Age > 18 years
- •Signed informed consent
排除标准
- •Patients who meet exclusion criteria for MRI
- •Patients who meet exclusion criteria for intravenous gadolinium-based
- •o Glomerular Filtration Rate (GFR) of <30 mL/min/1.73m2
- •o Nephrogenic Systemic Fibrosis (strict contra-indication for gadolinium-based
- •o Known allergy for gadolinium-based contrast
- •Patients with a blood plasma glucose concentration >10 mmol/L or poorly
- •controlled diabetes mellitus
- •Irradical endoscopic mucosal resection (EMR) or endoscopic submucosal
- •dissection (ESD) of primary tumor prior to start of neoadjuvant
- •chemoradiotherapy
- •Pregnant or breast-feeding patients
研究者
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