Radiotherapy after Oesophageal Cancer Stenting (ROCS) study
| ISRCTN | ISRCTN12376468 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12376468 |
| ClinicalTrials.gov (NCT) | NCT01915693 |
| Protocol serial number | HTA 10/50/49, WCTU030 |
| Sponsor | Velindre NHS Trust (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK), 10/50/49 |
- 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
Plain English summary of protocol
Contact information
Scientific
Ward 32
Ninewells Hosptial
Dundee
DD1 9SY
United Kingdom
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 |
|---|---|
| ROCS@cardiff.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Two-arm open randomised phase III trial with a 1:1 randomisation ratio. A qualitative component in a sub-set of patients. |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
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. |
| Key secondary outcome measure(s) |
1. Assess the impact of combination treatment on core components of health related quality of life |
| Completion date | 30/11/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 496 |
| Total final enrolment | 220 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2012 |
| Date of final enrolment | 31/08/2018 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
DD1 9SY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2021 | 22/02/2021 | Yes | No |
| Results article | 01/05/2021 | 28/05/2021 | Yes | No | |
| Protocol article | protocol | 22/10/2014 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| 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.
