MRI and CT Simulation in the Evaluation of Tumor Response and Target Volume Definition for Esophageal or Esophagogastric Cancer Patients Undergoing Chemoradiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Tumor response based on MRI and CT simulation
研究概览
简要总结
Magnetic resonance imaging (MRI) with functional features of diffusion weighted imaging (DWI) are advancing imaging technologies that have potential to overcome limitations of conventional staging methods, radiation treatment planning and the assessment of tumor response in esophageal or esophagogastric cancer. This study aimed to explore the value of MRI for the prediction of tumor response to chemoradiotherapy and accurate target volume delineation as compared to CT simulation for patients with unresectable or potentially resectable esophageal or esophagogastric cancer undergoing chemoradiotherapy. The average CT texture features are also extracted before and during treatment to establish a model to predict the prognosis or side effects (e.g. radiation pneumonitis or esophagitis) of patients.
详细描述
- Both DW-MRI and CT simulation will be performed before chemoradiotherapy and after 18-22 fractions. Also MRI will be performed after treatment. The investigators will contour based on the MRI image and compare this with the standard CT plan before and during treatment.
- The predictive potential of initial tumor ADC, and change in ADC during and after treatment for tumor response will be assessed.
- The average CT texture features not only in the present study but also of those who treated previously in our department (since 2014) will be extracted before and during chemoradiotherapy to establish a model to predict the prognosis of patients.
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
- •Histologically confirmed squamous cell carcinoma, adenocarcinoma of the esophageal or esophagogastric junction
- •Unresectable or potentially resectable tumor (cT3-4N0-1M0-M1a, according to AJCC 6th) based on standard primary staging by EUS and CT
- •Age>18 years
- •No distant metastasis other than supraclavicular lymph nodes
- •No prior history of thoracic radiation or chemotherapy
- •Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,500 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits
- •Informed consent
排除标准
- •Contraindication for MRI scanning
- •Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
- •Pregnant or lactating females
- •Contraindication for radiotherapy or chemotherapy
研究组 & 干预措施
Esophageal or esophagogastric cancer
干预措施: Paclitaxel, platinum-based drug (Drug)
Esophageal or esophagogastric cancer
干预措施: MRI and CT (Device)
Esophageal or esophagogastric cancer
干预措施: Ratiotherapy (Radiation)
结局指标
主要结局
Tumor response based on MRI and CT simulation
时间窗: up to 8 weeks
Radiotherapy target volume assessment with pre- and post-chemoradiotherapy based on MRI and CT simulation
时间窗: up to 8 weeks
Evaluation of tumor heterogeneity with IBEX software
时间窗: up to 8 weeks
Using the average CT images for texture extraction. Histogram, gradient, cooccurrence, gray-tone difference, and filtration-based techniques are used for texture feature extraction. Models incorporating texture features are established to compare to models incorporating clinical prognostic factors alone.
次要结局
- Overall survival(1 year)
- Progress free survival(1 year)
- Reduction in acute and late side effects based on modified RT treatment volumes with pre- and post-chemoradiotherapy based on MRI and CT simulation(1 year)
研究者
XIN WANG
MD
Cancer Institute and Hospital, Chinese Academy of Medical Sciences