NCT01463501Unknown2 期
Prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy (Paclitaxel and Carboplatin) Followed by Surgery to Surgery Followed by Postoperative Chemoradiotherapy (Paclitaxel and Carboplatin) for Esophageal Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Scores of Quality of life
研究概览
简要总结
This is a prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy (Paclitaxel and carboplatin) Followed by Surgery to Surgery Followed by Postoperative Chemoradiotherapy (Paclitaxel and carboplatin) for Esophageal Cancer.
详细描述
Patient Population:
Thoracic esophageal cancer able to tolerate tri-modality therapy; Clinical stage T3-4, N0-1, M0
Scheme:
Patients are randomized to 2 arms:
Arm A:
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 65 Years（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 (> 20cm from the incisors) or gastroesophageal junction are included.
- •No distant metastases (M0).
- •Patients will be stratified by stage (clinical N0 versus clinical N1).
- •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
Experimental
Preoperative chemotherapy/radiotherapy
干预措施: Neoadjuvant chemoradiotherapy (Other)
Adjuvant Treatment
Experimental
Postoperative chemotherapy/radiotherapy
干预措施: Adjuvant chemoradiotherapy (Other)
结局指标
主要结局
Scores of Quality of life
时间窗: 1 year
Assess the quality of life based on FACT-E.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: 1 year
Assess the safety and tolerability based on NCI CTC V4.0
次要结局
- Disease-free Survival(3 years)
- Overall Survival(3 years)
研究者
研究点 (2)
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