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The University of Southampton
Southampton Clinical Trials Unit

BioStent Trial

Trial Name

BIOSTENT - Biodegradable oesophageal stents plus radiotherapy in carcinoma of the oesophagus 

Description

Around 2/3 patients with oesophageal carcinoma are unsuitable for curative treatment because of tumour extent, or other health concerns which preclude aggressive treatment. The commonest symptom of oesophagus cancer is the inability to swallow (dysphagia), a distressing symptom for patients and their families. Self-expanding metal stents (SEMS) are widely used and provide rapid improvement in swallowing . SEMS are associated with complications however e.g. long term pain, food impaction, bleeding and gastro-oesophageal reflux. Stent slippage, necessitating removal and/or replacement is more common for stents placed in the region of the gastro oesophageal junction, now the predominant location for oesophageal cancers.

In studies of SEMS, up to 40% of patients needed re-intervention for dysphagia although there is variation with the type of stent used. Replacement of stents is not only inconvenient and uncomfortable for patients, with a risk of oesophageal perforation, but is estimated to cost the NHS on average £3015 per procedure. Little is currently known about daily life or patient and carer support needs following insertion of an oesophageal stent. It is therefore important that we develop improved treatment strategies for dysphagia from oesophageal cancer.

Objectives

Primary objective:

Secondary objectives:

Design

Phase II, single arm, 2-stage investigational study with a qualitative sub-study in two centres to test the effectiveness of biodegradable stents plus 1-2 weeks of radiotherapy in patients with swallowing problems from incurable oesophagus cancer.

Status

Complete

Population

Patients aged 18 or over requiring stent for oesophageal cancer.

Initially up to 19 patients will be recruited; if a maximum of 4 patients require re-intervention by 16 weeks post insertion of their stent then a maximum of 40 additional patients will be recruited, otherwise accrual will close once 5 patients have required re-intervention. If no more than 12 out of the total 59 patients require re-intervention for dysphagia by 16 weeks post stent insertion then the treatment is deemed worthy of testing in a subsequent randomised phase III trial.

A sub-group of 10-15 patients and their family caregivers will be invited to participate in semi-structured qualitative interviews (max. 1 hr.) i) following stent insertion and ii) when the stent has dissolved and radiotherapy effects are known.

Contact details

All Trial enquiries should be addressed to ctu@soton.ac.uk

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