NCT00220103已完成2 期
Pre-operative Epirubicin, Capecitabine (Xeloda) and Cisplatin in Patients With Newly Diagnosed Localised Oesophageal Adenocarcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pathological complete response rate
研究概览
简要总结
To investigate the efficacy and safety of epirubicin, cisplatin and capecitabine as neoadjuvant therapy prior to radical resection in patients with newly diagnosed operable oesophageal adenocarcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Age > 18 years.
- •Histologically verified adenocarcinoma of the thoracic oesophagus or type 1, 2 and 3 tumours of the oesophagogastric junction (type 1 refers to lower oesophageal, type 2 refers to cardial and type 3 refers to subcardinal cancers).
- •AJCC Stage II-III (T2-3 N0-1 M0) (28), as assessed by spiral or multi-slice CT and endoscopic ultrasound, where primary surgery would be considered with curative intent.
- •No previous chemotherapy, radiotherapy or other investigational drug treatment for this indication.
- •WHO performance status 0,1 or
- •Adequate bone marrow function with platelets > 100 x 109/l; WBC > 3 x 109/l; neutrophils > 1.5 x 109/l at the time of study entry.
- •Serum bilirubin < 35 mol/l.
- •Serum creatinine < 180 mol/l and measured creatinine clearance over 60ml/min.
- •No concurrent uncontrolled medical condition.
- •No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix in the last 10 years.
- •Life expectancy > 3 months.
- •Adequate contraceptive precautions if relevant.
- •Informed written consent.
排除标准
- •The presence of locally advanced or metastatic disease precluding curative surgical resection (T4 or Stage IV or M1a-b)
- •Total dysphagia (O'Rourke's swallowing function scoring system 5) precluding swallowing of capecitabine even when crushed
- •Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
- •Patients with disease in any of the following areas on the basis of CT scan and/or endoscopic ultrasound:
- •Evidence of liver, lung or other distant metastases
- •Para-aortic/coeliac lymphadenopathy > 1cm diameter on CT, > 6mm diameter on EUS
- •Invasion of airways, aorta, pericardium, or lung
- •New York Heart Association classification Grade III or IV.
- •Uncontrolled angina pectoris.
- •Pregnancy or breast feeding.
- •Impaired renal function with measured creatinine clearance less than 60 ml/min.
- •Known malabsorption syndromes.
- •Patients with a known hypersensitivity to 5-FU or with a dihydropyrimidine dehydrogenase (DPD) deficiency.
结局指标
主要结局
Pathological complete response rate
次要结局
- To assess the value of high resolution MRI to depict response to treatment and compare it with EUS and histopathology
- Progression free survival
- Overall survival
- Objective response rate assessed by CT and EUS
- Treatment related toxicity including peri-operative complications
- Time to improvement of dysphagia
- Pattern of treatment failure
研究者
研究点 (1)
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