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

ISRCTN	ISRCTN70483153
DOI	https://doi.org/10.1186/ISRCTN70483153
Protocol serial number	16452
Sponsor	Southampton University Hospitals NHS Trust (UK)
Funder	NIHR Research for Patient Benefit (RfPB)

Submission date: 22/05/2014
Registration date: 22/05/2014
Last edited: 15/11/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-biodegradable-stents-and-radiotherapy-for-cancer-of-the-oesophagus-biostent

Contact information

Ms Kelly Cozens
Scientific

MP131 University of Southampton Clinical Trials Unit
Tremona Road
Southampton
SO16 6YD
United Kingdom

Phone	+44 (0)23 8120 8834
Email	K.Cozens@southampton.ac.uk

Study information

Primary study design	Interventional
Study design	Non-randomised; Interventional and Observational; Design type: Treatment, Qualitative
Secondary study design	Non randomised controlled trial
Scientific title	The BioStent study: Biodegradable oesophageal Stents plus radiotherapy in carcinoma of the oesophagus: a non-randomised trial
Study acronym	BioStent
Study objectives	To determine whether, for this patient group, a treatment comprising biodegradable (BD) stent plus 1-2 weeks of radiotherapy (RT) is sufficiently effective in palliating dysphagia in terms of re-intervention rates to warrant a randomised controlled trial (RCT) against the current standard of care, at present self-expanding metal stent (SEMS).
Ethics approval(s)	NRES Committee London – Dulwich, 12/06/2014, ref: 14/LO/0389 (ammendment received 29/10/2015)
Health condition(s) or problem(s) studied	Topic: Cancer; Subtopic: Upper Gastro-Intestinal Cancer; Disease: Oesophagus
Intervention	Biodegradable Stent: Biodegradable (BD) stents manufactured by Ella-CS, Hradec Kralove, Czech Republic will be inserted in accordance with the standard procedures of the treating centre. Radiotherapy: Radiotherapy dose will be prescribed to the midplane and will be 20Gy in 5 daily fractions over one week or 30Gy in 10 daily fractions over two weeks.; Follow Up Length: 12 month(s); Study Entry : Registration only
Intervention type	Other
Primary outcome measure(s)	Need for a further intervention for dysphagia; Timepoint(s): 16 weeks following stent insertion.
Key secondary outcome measure(s)	1. Description of changes in overall symptom/quality of life/anxiety & depression/nutrition scores; Timepoint(s): 52 weeks from Stent insertion 2. Feasibility of collecting overall symptom/QoL/anxiety&depression scores in this patient group; Timepoint(s): 52 weeks from Stent Insertion 3. Median times to deterioration of these scores.; Timepoint(s): 52 weeks from Stent insertion 4. Overall survival; Timepoint(s): 52 weeks from Stent insertion 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 6. The incidence and severity of stent related side effects/complications; Timepoint(s): 52 weeks from Stent insertion
Completion date	01/07/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	59
Total final enrolment	14
Key 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
Key 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)
Date of first enrolment	01/07/2014
Date of final enrolment	02/04/2017

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

University Hospital Southampton

Tremona Rd
Southampton
SO16 6YD
United Kingdom

Basingstoke and North Hampshire Hospital

Aldermaston Rd
Basingstoke
Hampshire
RG24 9NA
United Kingdom

Christie NHS Foundation Trust

550 Wilmslow Rd
Manchester
M20 4BX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data-sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	01/05/2021	07/05/2021	Yes	No
HRA research summary		28/06/2023	No	No
Plain English results		15/11/2022	No	Yes

Editorial Notes

15/11/2022: Link added to plain English results.
07/05/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
16/10/2019: The scientific contact was changed from Julia Abab to Kelly Cozens.
12/05/2016: The recruitment end date has been update from 01/03/2017 to 02/04/2017 and the overall trial end date has been updated from 01/07/2017 to 01/07/2018.
11/05/2016: Ethics approval information added.
14/04/2016: Changed study contact details. Amended inclusion/exclusion criteria (as indicated in appropriate field). Added three trial participating centres.
07/04/2016: Ethics approval information added.