NCT00907543已完成不适用
Prospective Randomized Phase III Trial Comparing Preoperative Chemoradiation Therapy (Cisplatin, 5-FU and Radiotherapy Followed by Surgery) to Surgery Followed by Postoperative Chemoradiation (Cisplatin, Epirubicin, 5-FU, Radiotherapy) for Esophageal Cancer
Richard Malthaner2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2009年4月最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Quality of life as assessed by FACT-E
研究概览
简要总结
The purpose of this study is to compare the results of preoperative chemotherapy and radiation followed by surgery to surgery followed by postoperative chemotherapy and radiation for esophageal cancer.
详细描述
Patients will be randomized to neo-adjuvant or adjuvant treatment. Quality of life questionnaires will be completed every 2 months up to 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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 documented squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (> 20 cm from the incisors) or gastroesophageal junction are included.
- •No distant metastases (M0).
- •Patients will be stratified by stage (clinical N0 versus clinical N1), and surgeon.
- •Patients with tumours within 3 cm distal spread into gastric cardia as detected by esophagogastroscopy.
- •Resectable mediastinal nodes are eligible.
- •No prior chemotherapy for this malignancy.
- •No prior radiotherapy that would overlap the field(s) treated in this study.
- •Patients with other malignancies are eligible only if > 5 years without evidence of disease or completely resected or treated non-melanoma skin cancer.
- •Age > 18 years and able to tolerate tri-modality therapy at the discretion of the treating thoracic surgeon, medical and radiation oncologists. Tumours must be resectable after assessment by the thoracic surgeon.
排除标准
- •Cancers of the cervical esophagus (< 20 cm are excluded).
- •Tumours that have > 3 cm of spread into cardia of the stomach are considered gastric cancers and are ineligible.
- •Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy ) proven metastatic supraclavicular nodes are ineligible.
- •Patients with biopsy proven metastatic celiac nodes are ineligible.
研究组 & 干预措施
Neoadjuvant Treatment
Other
Preoperative chemotherapy/radiotherapy treatment
干预措施: Preoperative treatment of chemotherapy and radiation (Other)
Adjuvant Treatment
Experimental
Postoperative chemotherapy/radiotherapy treatment
干预措施: Postoperative treatment of chemotherapy and radiation (Other)
结局指标
主要结局
Quality of life as assessed by FACT-E
时间窗: 1 year
次要结局
- Safety and morbidity(1 year)
研究者
Richard Malthaner
Sponsor-Investigator
Lawson Health Research Institute
研究点 (2)
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