Radiotherapy after Oesophageal Cancer Stenting (ROCS) study

ISRCTN	ISRCTN12376468
DOI	https://doi.org/10.1186/ISRCTN12376468
ClinicalTrials.gov number	NCT01915693
Secondary identifying numbers	HTA 10/50/49, WCTU030

Submission date: 04/07/2012
Registration date: 10/07/2012
Last edited: 28/02/2023

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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-radiotherapy-oesophageal-cancer-difficulty-swallowing-rocs

Contact information

Dr Douglas Adamson
Scientific

Ward 32
Ninewells Hosptial
Dundee
DD1 9SY
United Kingdom

Ms Martina Svobodova
Public

Centre for Trials Research (CTR)
College of Biomedical and Life Sciences
Cardiff University
6th Floor, Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom

Phone	+44(0)29 20687463
Email	ROCS@cardiff.ac.uk

Study information

Study design	Two-arm open randomised phase III trial with a 1:1 randomisation ratio. A qualitative component in a sub-set of patients.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Palliative radiotherapy in addition to self-expanding metal stent for improving dysphagia and survival in advanced oesophageal cancer: Radiotherapy after Oesophageal Cancer Stenting (ROCS) study
Study acronym	ROCS
Study hypothesis	Radiotherapy in addition to self-expanding metal stent (SEMS) placement improves patient-reported dysphagia and increases time to progression in a patient population unable to undergo surgery. More details can be found at http://www.nets.nihr.ac.uk/projects/hta/105049 Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0009/81666/PRO-10-50-49.pdf
Ethics approval(s)	Not provided at time of registration
Condition	Oesophageal cancer requiring stent for relief of dysphagia
Intervention	Arm A: Self-expanding metal stents (SEMS) (Control Arm) SEMS insertion will be undertaken in accordance with standard local protocols. Covered or partially covered metal stents will be used and the length type and mode of stent placement will be selected by the clinician. Insertion will occur within two weeks of randomisation. Arm B: SEMS plus external beam radiotherapy (Intervention Arm) External beam radiotherapy (EBRT) is routinely available at regional cancer centres across the UK. For palliation of dysphagia in oesophageal cancer, a radiotherapy course delivering a tumour absorbed dose of 20Gy in 5 fractions or 30Gy in 10 fractions within 4 weeks of SEMS insertion.
Intervention type	Other
Primary outcome measure	Assess the impact of radiotherapy in addition to self-expanding metal stent (SEMS) placement on time to progression of patient-reported dysphagia in a patient population unable to undergo surgery.
Secondary outcome measures	1. Assess the impact of combination treatment on core components of health related quality of life 2. Assess the impact of radiotherapy in addition to SEMS placement on overall survival 3. Measure morbidity associated with the interventions 4. Measure re-intervention rates 5. Assess the cost of the addition of radiotherapy to SEMS placement
Overall study start date	01/10/2012
Overall study end date	30/11/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	496
Total final enrolment	220
Participant inclusion criteria	1. Histological confirmation of oesophageal carcinoma excluding small cell histology 2. Not suitable for radical treatment (oesophagectomy or radical chemoradiotherapy) either because of patient choice or medical reasons 3. Dysphagia clinically assessed as needing stent as primary treatment of the dysphagia 4. Age 16 years or over 5. Discussion and treatment decision for SEMS placement made by an Upper GI multi-disciplinary team 6. Clinician assessment of ability to attend for radiotherapy 7. Expected survival of at least 12 weeks 8. Written informed consent
Participant exclusion criteria	1. Histology of small cell carcinoma type 2. Tumour length of greater than 12 cm 3. Tumour growth within 2 cm of the upper oesophageal sphincter 4. Endoscopic treatment of the tumour, other than dilatation, planned in the peri-stent period 5. Presence of a tracheo-oesophageal fistula 6. Presence of a pacemaker 7. Previous radiotherapy to the area of the proposed radiotherapy field 8. Planned endoscopic treatment of the tumour (e.g. laser) in the immediate peri-stenting period 9. Pregnancy
Recruitment start date	01/10/2012
Recruitment end date	31/08/2018

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Ward 32

Dundee
DD1 9SY
United Kingdom

Sponsor information

Velindre NHS Trust (UK)
Hospital/treatment centre

Mrs Sarah Townsend
Research & Development Office
Velindre NHS Trust
3rd Floor
14 Cathedral Road
Cardiff
CF11 9LJ
Wales
United Kingdom

"ROR"	https://ror.org/05ntqkc30

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK), 10/50/49

No information available

Results and Publications

Intention to publish date	30/03/2021
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	22/10/2014		Yes	No
Results article	results	01/04/2021	22/02/2021	Yes	No
Results article		01/05/2021	28/05/2021	Yes	No
Plain English results			28/02/2023	No	Yes

Editorial Notes

28/02/2023: Link to plain English results added.
28/05/2021: Publication reference and ClinicalTrials.gov number added.
22/02/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
08/02/2021: The link to the PES was updated.
18/12/2020: Contact details updated.
10/12/2020: The intention to publish date was changed from 30/09/2019 to 30/03/2021.
10/09/2018: The following changes have been made:
1. The recruitment end date has been changed from 30/09/2018 to 31/08/2018.
2. The overall trial end date has been changed from 30/09/2018 to 30/11/2018.
3. The intention to publish date has been added.
4. Martina Svobodova has been added as the public contact.