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

ISRCTN ISRCTN70483153
DOI https://doi.org/10.1186/ISRCTN70483153
Secondary identifying numbers 16452
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

Study designNon-randomised; Interventional and Observational; Design type: Treatment, Qualitative
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThe BioStent study: Biodegradable oesophageal Stents plus radiotherapy in carcinoma of the oesophagus: a non-randomised trial
Study acronymBioStent
Study objectivesTo 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) studiedTopic: Cancer; Subtopic: Upper Gastro-Intestinal Cancer; Disease: Oesophagus
InterventionBiodegradable 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 typeOther
Primary outcome measureNeed for a further intervention for dysphagia; Timepoint(s): 16 weeks following stent insertion.
Secondary outcome measures1. 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
Overall study start date01/07/2014
Completion date01/07/2018

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 59; UK Sample Size: 59
Total final enrolment14
Key inclusion criteriaEligible 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 criteria1. 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 enrolment01/07/2014
Date of final enrolment02/04/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

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

Sponsor information

Southampton University Hospitals NHS Trust (UK)
Hospital/treatment centre

Cancer Care Directorate
B Level, Mailpoint WRE
Royal South Hants Hospital, Graham Road
Southampton
SO14 0YG
England
United Kingdom

ROR logo "ROR" https://ror.org/0485axj58

Funders

Funder type

Government

NIHR Research for Patient Benefit (RfPB)

No information available

Results and Publications

Intention to publish date01/07/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planAt trial closure and following consent from the TMG and DMEC the results will be published in peer review journals, conference presentations and dissemination at local and national oesophageal cancer patient groups.
IPD sharing planThe data-sharing plans for the current study are unknown and will be made available at a later date

Study outputs

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

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.