The BioStent study: Biodegradable oesophageal Stents plus radiotherapy in carcinoma of the oesophagus

Phase 2

Completed

• Conditions: Topic: Cancer; Subtopic: Upper Gastro-Intestinal Cancer; Disease: Oesophagus; Cancer

• Registration Number: ISRCTN70483153
• Lead Sponsor: Southampton University Hospitals NHS Trust (UK)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-22
• Study Completion: 2018-07-01
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

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.
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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eed for a further intervention for dysphagia; Timepoint(s): 16 weeks following stent insertion.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Description of changes in overall symptom/quality of life/anxiety & depression/nutrition scores; Timepoint(s): 52 weeks from Stent insertion<br> 2. Feasibility of collecting overall symptom/QoL/anxiety&depression scores in this patient group; Timepoint(s): 52 weeks from Stent Insertion<br> 3. Median times to deterioration of these scores.; Timepoint(s): 52 weeks from Stent insertion<br> 4. Overall survival; Timepoint(s): 52 weeks from Stent insertion<br> 5. Patient and carer experience of trial processes, intervention-related support needs, & effect of; Timepoint(s): intervention on daily living (qualitative sub-study). 52 weeks from Stent insertion<br> 6. The incidence and severity of stent related side effects/complications; Timepoint(s): 52 weeks from Stent insertion<br>