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
Contact information
Ms Kelly Cozens
Scientific
Scientific
MP131 University of Southampton Clinical Trials Unit
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)23 8120 8834 |
|---|---|
| K.Cozens@southampton.ac.uk |
Study information
| Study design | Non-randomised; Interventional and Observational; Design type: Treatment, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | Need for a further intervention for dysphagia; Timepoint(s): 16 weeks following stent insertion. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/07/2014 |
| Completion date | 01/07/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 59; UK Sample Size: 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
- England
- United Kingdom
Study participating centres
University Hospital Southampton
Tremona Rd
Southampton
SO16 6YD
United Kingdom
Southampton
SO16 6YD
United Kingdom
Basingstoke and North Hampshire Hospital
Aldermaston Rd
Basingstoke
Hampshire
RG24 9NA
United Kingdom
Basingstoke
Hampshire
RG24 9NA
United Kingdom
Christie NHS Foundation Trust
550 Wilmslow Rd
Manchester
M20 4BX
United Kingdom
Manchester
M20 4BX
United Kingdom
Sponsor information
Southampton University Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Cancer Care Directorate
B Level, Mailpoint WRE
Royal South Hants Hospital, Graham Road
Southampton
SO14 0YG
England
United Kingdom
"ROR" |
https://ror.org/0485axj58 |
|---|
Funders
Funder type
Government
NIHR Research for Patient Benefit (RfPB)
No information available
Results and Publications
| Intention to publish date | 01/07/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | At 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 plan | The 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.
