A Randomised Phase II Study of Two Pre-operative Chemoradiotherapy Regimens (Oxaliplatin and Capecitabine Followed by Radiotherapy With Either Oxaliplatin and Capecitabine or Paclitaxel and Carboplatin) for Resectable Oesophageal Cancer
- Histologically confirmed operable oesophageal cancer (adenocarcinoma)
- Tumour must be staged as a T3, 4 or N1 (using TNM6 staging) or T3, T4a or N13
using TNM7 staging)
- Maximum disease (Tumour plus nodes) length 8 cm staged with EUS and CT/PET
- WHO performance status 01
- Adequate haematological, renal, respiratory, cardiac and hepatic function
- The patient has provided written informed consent.
- Histologically confirmed operable oesophageal cancer (squamous cell carcinoma)
- Uncontrolled angina pectoris, myocardial infarction within 6 months, heart failure,
clinically significant uncontrolled cardiac arrhythmias, or any patient with a
clinically significant abnormal ECG.
- Patients with any previous treatment for oesophageal carcinoma.
- Siewert type 3 oesophagogastric tumours.
- T4 tumours invading contiguous structures other than diaphragm, crura or mediastinal
- Patients with disease in any of the following areas on the CT scan, EUS or other
1. Evidence of metastases in liver, lung, bone or other distant metastases.
2. Abdominal para aortic lymphadenopathy >1cm diameter on CT or >6mm diameter on
3. Invasion of tracheo-bronchial tree, aorta, pericardium or lung.
- Lymphadenopathy encasing the coeliac axis (as described above, patients with single
nodes lying anterior to the origin of the splenic artery and anterior to the origin
of the coeliac axis are not excluded).
- Any patient with a single significant medical condition which is thought likely to
compromise his or her ability to tolerate any of the above therapies.
- Specific contraindications to surgery, chemotherapeutic agents (including known
allergies to chemotherapy) or radiotherapy.
- Pregnant or lactating women and fertile women who will not be using adequate
contraception during the trial.