Oesophageal cancer Cancer Oesophageal cancer
Conditions
Interventions
Control arm: chemoradiation
Experimental arm: chemoradiation plus cetuximab
Sponsors
Velindre NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Phase II: 1. Toxicity 2. Feasibility Phase III: 1. Toxicity 2. Health economics 3. Quality of life 4. Quality assurance | — |
Primary
| Measure | Time frame |
|---|---|
| Phase II: treatment failure Phase III: overall survival | — |
Countries
United Kingdom
Outcome results
None listed