Feasibility trial of chemoradiation or surgery for oesophageal cancer
Research type
Research Study
Full title
Oesophageal squamous cell cancer: chemoradiotherapy versus chemotherapy and surgery - a feasibility study
IRAS ID
13556
Contact name
Jane Blazeby
Contact email
Sponsor organisation
UNIVERSITY HOSPITALS Bristol NHS Foundation Trust
Eudract number
2009-013877-16
Research summary
Cancer of the gullet (oesophagus) is a serious disease that's difficult to treat. There are two types of oesophageal cancer and for the squamous cell type there are two treatments that are widely used to try and cure the disease. One involves chemotherapy (drug treatment that kills cancer cells) and then surgery (to excise the cancer within the oesophagus). The other treatment involves chemotherapy and then chemotherapy and radiotherapy together (radiotherapy burns and kills cancer cells). At present there is a lack of high quality evidence that compares the two treatments and selecting a treatment depends upon doctors' or patients?? preferences and not on evidence about which treatment produces the best outcomes. The aim of this study is to determine the feasibility of a randomised trial of chemotherapy and oesophagectomy versus chemotherapy and chemoradiotherapy for patients with oesophageal squamous cell cancer. It will randomise patients with localised oesophageal squamous cell cancer to two treatments, surgery or chemoradiation treatment. If the full multi-centre trial is feasible it will provide high quality evidence to use in clinical practice and inform treatment choice. The feasibility study will also establish methods for recruiting participants from multi-disciplinary cancer team meetings into randomised trials. It will use qualitative research to work with doctors and nurses to improve communication with patients regarding the two types of treatments and to improve trial recruitment. Additionally surveys with health professionals and patients will be undertaken to identify the core information to be communicated about each treatment.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
09/H0106/69
Date of REC Opinion
30 Oct 2009
REC opinion
Further Information Favourable Opinion