• Relief of dysphagia [ Time Frame: This will be measured at nine weeks after the start of radiotherapy and must be maintained at the next review 4 weeks thereafter. ]
  

• Dysphagia progression free survival. [ Time Frame: This will be measured from randomisation to the time of first progression of dysphagia. ]
  
• Quality of Life differences post treatment and at 3 months and 6 months. [ Time Frame: post treatment and at 3 months and 6 months. ]
  
• Acute and late toxicity. [ Time Frame: Interim analyses planned at 110 pateints. Final analyses will occur after 5 years. ]
  
• Survival. [ Time Frame: Interim analyses planned at 110 pateints. Final analyses will occur after 5 years. ]
  
• Time to achieving any response in dysphagia after treatment as measured by an improvement of at least 1 point on the 5 point dysphagia scale. [ Time Frame: Interim analyses planned at 110 pateints. Final analyses will occur after 5 years. ]
  
• Number of patients receiving secondary treatment (radiation, chemotherapy or stenting). [ Time Frame: Interim analyses planned at 110 pateints. Final analyses will occur after 5 years. ]
  
• Time to achieving a complete response i.e. dysphagia score of 0. [ Time Frame: Interim analyses planned at 110 pateints. Final analyses will occur after 5 years. ]
  

Prospective radical treatment trials in oesophageal cancer have shown responses in both radiotherapy alone and radiotherapy when combined with chemotherapy. Retrospective studies show a response in the palliative setting to relieve dysphagia. The response, durability and quality of life end points have not been previously fully documented. This will be addressed by this trial.

Dysphagia is the commonest presenting symptom due to local disease obstructing the oesophagus. Difficulty eating not only affects the patient's ability to maintain nutrition, but also impacts on all areas of quality of life. Relief of dysphagia becomes the highest priority for treatment.

At the time of developing this protocol there were no randomised trials comparing chemo-radiotherapy and radiotherapy in the palliative setting.

Few studies have prospectively assessed quality of life data for patients with oesophageal cancer, and although toxicity and survival data is available, there is no long-term data on quality of life. This trial will assess quality of life in a consecutive manner using a standardised self-reporting measure of quality of life, and compare quality of life across two groups having different treatments.

Eligible patients are those with proven carcinoma of the oesophagus who are deemed not suitable for definitive radical treatment due to the advanced nature of disease, presence of metastases or intercurrent illness, who have symptomatic dysphagia requiring loco-regional palliation.

Patients will be randomised to the following treatment options:

1. Radiotherapy Alone

   • 35 Gy in 15 fractions (Australia and New Zealand) or
   • 30 Gy in 10 fractions(Canada ONLY)

2. Chemo-Radiotherapy

   • 35 Gy in 15 fractions (Australia and New Zealand) or
   • 30 Gy in 10 fractions (Canada ONLY)
   • Cisplatin 80mg/m2 IV day 1 (or 20mg/m2/day IV days 1 - 4)
   • 5-Fluorouracil 800mg/m2/day IV days 1 - 4

Patients will have an initial baseline assessment then be followed up weekly during treatment, monthly for 1 year post treatment and then 3 monthly.