A Randomised Phase II Trial of Weekly Docetaxel (Taxotere) Chemoradiotherapy +/- Cetuximab (Erbitux) for Localised Resectable Cancer of the Oesophagus

INTERVENTION: Intervention Arm: Induction chemotherapy: 2 cycles of 4 weeks of Docetaxel (D), Cisplatin (C), 5‐fluorouracil (5FU) and Cetuximab: Docetaxel 35mg/m2 by intravenous drip on days 1, 8 and 15 of every 4 week cycle, Cisplatin 25mg/m2 by intravenous drip on days 1, 8 and15 of every 4 week cycle, 5FU, 150mg/m2/day by continuous infusion from days 1‐21 of every 4 week cycle, Cetuximab initial dose 400mg/m2 by intravenous drip on day 1, then 250mg/m2 by intravenous drip on days 1, 8, 15 and 22 of every 4 week cycle, Chemotherapy break: 1 week prior to chemoradiotherapy, cetuximab given alone at 250mg/m2 by intravenous drip Chemoradiotherapy: 1 cycle of 5 weeks of Docetaxel (D), Cisplatin (C), Radiotherapy (RT) and Cetuximab: Docetaxel 35mg/m2 by intravenous drip on days 1, 8, 15, 22 and 29 of chemoradiotherapy Cisplatin 25mg/m2 by intravenous drip on days 1, 8, 15, 22 and 29 of chemoradiotherapy Radiotherapy 50.4 Gray (28 fractions/5 fractions per week) Cetuximab 250mg/m2 by intravenous drip on days 1, 8, 15, 22 and 29 of chemoradiotherapy Surgery: Following restaging to exclude metastatic disease, surgery will be performed within 4‐8 weeks of completion of chemoradiotherapy. CONDITION: Localised resectable cancer of the oesophagus PRIMARY OUTCOME: Pathological complete response rate determined from surgical specimens in resectable patients SECONDARY OUTCOME: Disease‐free survival Early Fluorodeoxyglucose Positron Emission Tomography (FDG PET) response (where assessed). Feasibility in terms of the extent of delivery of the planned treatment regimen Overall survival Post‐treatment Fluorodeoxyglucose Positron Emission Tomography (FDG PET) response rate (where assessed) Toxicity as measured by adverse events. Examples include febrile neutropaenia, nausea, vomiting and oesophagitis, which will be measured by clinican assessment and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCICTCAEv3.0). Late radiation toxicities including lung, heart and spinal cord will be measured by clinician assessment and graded according to the Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer(RTOG/EORTC) Late Radiation Morbidity Scoring Schema. INCLUSION CRITERIA: Adenocarcinoma of the oesophagus or oesophago‐gastric junction, suitable for definitive surgical resection. Eastern Cooperative Oncology Group (ECOG) performance status 0‐1.