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 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 trial start date
01/07/2014
Overall trial end date
01/07/2018
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list