NCT00193882

Advanced Oesophageal Cancer Study to Compare Quality of Life and Palliation of Dysphagia.

A Randomised Phase III Study in Advanced Oesophageal Cancer to Compare Quality of Life and Palliation of Dysphagia in Patients Treated With Radiotherapy vs ChemoRadiotherapy.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Trans Tasman Radiation Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the treatment of gullet cancer with radiotherapy alone and assess the advantage and toxicity of adding chemotherapy. The hypothesis to be tested is as follows: That the addition of chemotherapy to a short course of radiation treatment improves the proportion of patients who achieve relief of dysphagia and improves quality of life compared to radiation alone in patients with advanced oesophageal cancer.

Detailed description

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.

Conditions

• Esophagus Cancer

Interventions

Type	Name	Description
DRUG	Cisplatin	80mg/m2 IV day 1
RADIATION	Radiotherapy	35 Gy in 15 fractions
DRUG	5-Fluorouracil	800mg/m2/day IV days 1 - 4

Timeline

• Start date: 2003-07-07
• Primary completion: 2012-03-21
• Completion: 2013-06-18
• First posted: 2005-09-19
• Last updated: 2017-07-12

Locations

25 sites across 4 countries: Australia, Canada, New Zealand, United Kingdom