ISRCTN47718479已完成2 期
A randomised phase II/III multicentre clinical trial of definitive chemoradiation, with or without cetuximab, in carcinoma of the oesophagus
Velindre NHS Trust (UK)0 个研究点目标入组 420 人开始时间: 2006年5月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 420
研究概览
简要总结
- 2011 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/22035459 2. 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23623280 3. 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28196063
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Amended 11/02/2009:
- •The following points of the below criteria have been amended as follows:
- •2. Histologically confirmed carcinoma of the oesophagus (adenocarcinoma, squamous cell, or undifferentiated) or Siewert type 1 tumour of the gastro-oesophageal junction (GOJ) or Siewert Type 2 with no more than 2 cm mucosal extension into the stomach
- •3. Tumours staged with endoscopic ultrasonography (EUS) and spiral computerised tomography (CT) scan to be T1-4N0-1 confirming localised, non-metastatic disease
- •7. Adequate cardio-respiratory function for definitive CRT. (Echo or multiple-gated acquisition left ventricular (MUGA LV) function greater than 40% (no acute coronary event in previous six months, myocardial infarction or unstable angina), forced expiratory volume in one second (FEV1) greater than 1 litre)
- •8. Adequate renal function for definitive CRT (renal glomerular filtration rate greater than 60 ml/min (calculated using Cockroft formula with ethylenediaminetetraacetic acid (EDTA) if predicted less than 60 ml/min
- •9. Written informed consent to participate in the trial
- •Initial information at time of registration:
- •1. Patients older than 18 years of age who have been selected to receive potentially curative definitive chemo-radiation
- •2. Histologically confirmed carcinoma of the oesophagus (adenocarcinoma or squamous cell) or Siewert type 1 tumour of the gastro-oesophageal junction (GOJ)
- •3. Tumours staged with endorectal ultrasonography (EUS) and spiral computerised tomography (CT) scan to be T1-4N0-1 confirming localised, non-metastatic disease
- •4. Total disease length (primary tumour and lymph nodes) less than 10 cm defined by EUS
- •5. World Health Organization (WHO) performance status 0 or 1
- •6. Patients physically and psychologically fit and willing to receive definitive chemoradiation with or without cetuximab
- •7. Adequate cardio-respiratory function for definitive CRT. Echo or multiple-gated acquisition left ventricular (MUGA LV) function greater than 40% (no acute coronary event in previous six months, myocardial infarction or unstable angina), forced expiratory volume in one second (FEV1) greater than 1 litre, renal glomerular filtration rate greater than 60 ml/min (calculated using Cockroft formula with ethylenediaminetetraacetic acid (EDTA) if predicted less than 60 ml/min).
- •8. Written informed consent to participate in the trial
排除标准
- •Amended 11/02/2009:
- •The following points of the below criteria have been amended as follows:
- •3. Patients with previous treatment for malignancy, which will compromise ability to deliver definitive mediastinal chemoradiation or may compromise survival
- •Initial information at time of registration:
- •1. Patients who have had previous treatment for oesophageal carcinoma
- •2. Patients with metastatic disease i.e. M1a/coeliac nodes or M1b
- •3. Patients with previous treatment for malignancy, which will compromise ability to deliver definitive mediastinal chemoradiation
- •4. Patients with significant (greater than 2 cm) extension of tumour into the stomach
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