Organ Motion and Early Tumor Response Measurement During Chemotherapy for Esophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To quantify motion of the esophageal tumor over the course of chemoradiation
研究概览
简要总结
To quantify motion based variation of the target volume of the primary tumor over the course of chemoradiotherapy in esophageal cancer patients, and to use this information to calculate appropriate PTV (planning target volume) margins according to the margins recipe for patients receiving trimodality (neoadjuvant chemoradiation and surgery) or definitive chemoradiation in order to personalize radiation treatment, resulting in either better target coverage or a reduction in normal tissue radiation exposure.
详细描述
A single center prospective observational study will be performed in esophageal cancer patients. This study registers motion of the esophageal tumor, using 4D planning CT scans and repeated 4D CBCT scanning. Motion of fiducial markers inserted into the esophageal wall, will be used as a surrogate for tumor motion in the limited image quality of CBCT scans.
Patients planned for trimodality treatment will additionally be imaged by serial 4D Pet CT and MRI in week 0 (before start chemoradiotherapy), week 3 (during chemoradiotherapy) and week 10 (just prior to surgery) to observe (early) signs of tumor response.
Patients planned for definitive chemoradiation will not receive extra MRI imaging during treatment because of the inability to correlate this imaging with pathological response.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Histologic evidence of invasive adenocarcinoma or squamous cell cancer of the esophagus
- •Patient eligible for trimodality treatment (chemoradiotherapy and surgery) or definitive chemoradiotherapy
- •T3N0M0 or T1-4N1-3M
- •Patients with M1 disease solely on the basis of supraclavicular metastasis and not a junction tumor as primary are eligible. (AJCC 7th edition,).
- •WHO performance status ≤2 (WHO scale)
- •Clinically operable for R0 resection in the opinion of an experienced upper gastrointestinal or thoracic surgeon for patients planned for trimodality
- •Tumor localization at least 2cm from the upper esophageal sphincter and invading no more than 5cm into gastric cardia
- •Age ≥ 18 years
- •Written informed consent before endoscopy or EUS
- •Exclusion criteria:
- •Prior treatment with thoracic surgery or thoracic radiotherapy
- •Severe cardiopulmonary restriction
排除标准
- 未提供
结局指标
主要结局
To quantify motion of the esophageal tumor over the course of chemoradiation
时间窗: 6 weeks
The outcome measures will be assessed by tracking the motion of the fiducial markers at the daily 4D CBCT (four dimensional cone beam CT scan). (primary outcome) By observing the motion of the fiducial, the exact setup error, breathing motion amplitudes, intra- and inter-fraction motion can be assessed.
次要结局
未报告次要终点