ISRCTN70483153
Completed
Phase 2
The BioStent study: Biodegradable oesophageal Stents plus radiotherapy in carcinoma of the oesophagus: a non-randomised trial
Southampton University Hospitals NHS Trust (UK)0 sites14 target enrollmentMay 22, 2014
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Southampton University Hospitals NHS Trust (UK)
- Enrollment
- 14
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33402268/ (added 07/05/2021)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Eligible patients are those who would currently be offered a metal stent to palliate the symptom of dysphagia associated with their incurable oesophageal cancer and who are suitable for radiotherapy.
- •Specific eligibility criteria are:
- •1\. Histologically confirmed primary adenocarcinoma or squamous cell carcinoma of the oesophagus.
- •2\. Patients with poorly differentiated carcinoma thought to be of adenocarcinoma or squamous origin.
- •3\. Not suitable for radical surgery, radical radiotherapy, or concurrent chemoradiotherapy as a result of disease extent, comorbidities, performance status or patient choice.
- •4\. Oesophageal stent indicated and thought feasible.
- •5\. Estimated life expectancy thought to be 16 weeks or more (amended from 12 weeks as of 14/04/2016\)
- •6 Thought willing and able to comply with study interventions and assessments.
- •7\. Aged 18 years or more.
- •8\. Able to give informed consent.
Exclusion Criteria
- •1\. Prior radical surgery for oesophagus cancer.
- •2\. Chemotherapy in the 4 weeks prior to the start of radiotherapy.
- •3\. Prior radiotherapy to the region of the tumour.
- •4\. Known contraindication to radiotherapy.
- •5\. Patients with small cell carcinoma, other neuroendocrine tumours or other histologies.
- •6\. Presence of tracheooesophageal fistula.
- •7\. Oesophageal tumour length more than 12cm.
- •8\. Tumour within 2cm of the upper oesophageal sphincter.
- •9\. Pregnancy.
- •10\. Existing enteral tube feeding (unless removal planned prior to trial entry).
Outcomes
Primary Outcomes
Not specified
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