NCT00220129已完成2 期
Neoadjuvant Epirubicin, Cisplatin and Capecitabine (Xeloda) [ECX] Followed by Definitive Chemoradiation With or Without Surgery for Patients With Newly Diagnosed Localized Squamous Cell Carcinoma of the Oesophagus
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- 2 year overall survival
研究概览
简要总结
This is a study to investigate the efficacy and safety of epirubicin, cisplatin and capecitabine (ECX) as neoadjuvant therapy prior to radical chemoradiotherapy using capecitabine and cisplatin as radio-sensitisers in patients with newly diagnosed localized squamous cell carcinoma of the oesophagus.
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 squamous cell carcinoma of the cervical or thoracic oesophagus
- •American Joint Committee on Cancer (AJCC) Stage I-III (T1-3 N0-1 M0) (33), as assessed by spiral or multi-slice computed tomography (CT) and endoscopic ultrasound, where radical chemoradiation would be considered with curative intent.
- •No previous chemotherapy, radiotherapy or other investigational drug treatment for this indication.
- •World Health Organization (WHO) performance status 0,1 or
- •Adequate bone marrow function with platelets > 100 x 10^9/l; white blood cells (WBC) > 3 x 10^9/l; neutrophils > 1.5 x 10^9/l at the time of study entry.
- •Serum bilirubin < 35 micromol/l.
- •Serum creatinine < 180 micromol/l and measured creatinine clearance over 60 ml/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 chemoradiation (T4 or Stage IV or M1a-b) or disease not encompassable in a radical radiotherapy field.
- •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.
- •Intracerebral metastases or meningeal carcinomatosis.
- •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.
- •Previous investigational study drug
- •Known malabsorption syndromes
- •Patients with a known hypersensitivity to fluorouracil (5-FU) or with a dihydropyrimidine dehydrogenase (DPD) deficiency
- •Hearing loss
结局指标
主要结局
2 year overall survival
次要结局
- Objective clinical response rate assessed by computed tomography (CT), endoscopic ultrasound (EUS) and endoscopic biopsy
- Pattern of treatment failure
- Progression free survival
- Proportion of patients not achieving clinical complete response and requiring surgery after chemoradiation
- Treatment related toxicity
- Time to improvement of dysphagia
研究者
研究点 (1)
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