The BioStent study: Biodegradable oesophageal Stents plus radiotherapy in carcinoma of the oesophagus: a non-randomised trial

Southampton University Hospitals NHS Trust (UK)0 个研究点目标入组 14 人开始时间: 2014年5月22日最近更新: 2022年11月28日

适应症

试验速览

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33402268/ (added 07/05/2021)

•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.
•9. If subsequent chemotherapy is planned it is suggested that there is a minimum 2 week gap between the final fraction of radiotherapy and the first dose of chemotherapy.
•Patients will be invited to nominate the person, friend or relative, who is mostly responsible for providing unpaid care at home ('caregiver'). This person must be:
•1. Over 18 years
•2. Able to give informed consent
•3. Nominated by the patient

•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).
•11. Clinical significant GI bleed eg. Hematemesis, Melena or coffee ground hematemesis within the last 6 months. (added 14/04/2016)

发起方

Southampton University Hospitals NHS Trust (UK)