Cisplatin, capecitabine, and radiation therapy with or without cetuximab in treating patients with oesophageal cancer
- Conditions
- Oesophageal cancerCancer
- Registration Number
- ISRCTN47718479
- Lead Sponsor
- Velindre NHS Trust (UK)
- Brief Summary
1. 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 420
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Phase II: treatment failure<br> Phase III: overall survival<br>
- Secondary Outcome Measures
Name Time Method <br> Phase II:<br> 1. Toxicity<br> 2. Feasibility<br><br> Phase III:<br> 1. Toxicity<br> 2. Health economics<br> 3. Quality of life<br> 4. Quality assurance<br>