Condition category
Cancer
Date applied
22/05/2014
Date assigned
22/05/2014
Last edited
12/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Ms Julia Abab

ORCID ID

Contact details

MP131 University of Southampton Clinical Trials Unit
Tremona Road
Southampton
SO16 6YD
United Kingdom
-
j.abab@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16452

Study information

Scientific title

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

Acronym

BioStent

Study hypothesis

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

NRES Committee London – Dulwich, 12/06/2014, ref: 14/LO/0389 (ammendment received 29/10/2015)

Study design

Non-randomised; Interventional and Observational; Design type: Treatment, Qualitative

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Phase II

Drug names

Primary outcome measures

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 trial start date

01/07/2014

Overall trial end date

01/07/2018

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 59; UK Sample Size: 59

Participant 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)

Recruitment start date

01/07/2014

Recruitment end date

02/04/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital Southampton
Tremona Rd
Southampton
SO16 6YD
United Kingdom

Trial participating centre

Basingstoke and North Hampshire Hospital
Aldermaston Rd Basingstoke
Hampshire
RG24 9NA
United Kingdom

Trial participating centre

Christie NHS Foundation Trust
550 Wilmslow Rd
Manchester
M20 4BX
United Kingdom

Sponsor information

Organisation

Southampton University Hospitals NHS Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Research for Patient Benefit (RfPB)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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.

Intention to publish date

01/07/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.