ROCS (Radiotherapy After Oesophageal Cancer Stenting) Study
ROCS
Palliative Radiotherapy in Addition to Self-expanding Metal Stent for Improving Dysphagia and Survival in Advanced Oesophageal Cancer: ROCS (Radiotherapy After Oesophageal Cancer Stenting) Study.
2 other identifiers
interventional
220
1 country
17
Brief Summary
The single most distressing symptom for more than 70% of patients with oesophageal cancer is difficulty in swallowing (dysphagia) caused by blockage of the gullet by a tumour. This causes severe restrictions on food intake, physical activity, social functioning and overall quality of life. Amongst the more effective treatments for improving swallowing, is the insertion of a metal stent across the blocked part, which then self-expands to open up the gullet (Self Expanding Metal Stent or SEMS). The addition of radiotherapy may help to improve the problems caused by dysphagia and provide an additional survival benefit. The purpose of this study is to test the impact of adding radiotherapy to SEMS on:
- the length of time swallow remains improved for
- quality of life
- survival
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2013
Longer than P75 for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2013
CompletedFirst Posted
Study publicly available on registry
August 5, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedJune 4, 2019
June 1, 2019
5.1 years
July 31, 2013
June 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
patient-reported dysphagia
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.
within one year
Secondary Outcomes (5)
quality of life
within one year
overall survival
one year
morbidity
one year
re-intervention rate
one year
cost
one year
Study Arms (2)
Arm A: Self-expanding metal stents (SEMS) (Control Arm)
NO INTERVENTIONSEMS 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)
EXPERIMENTALExternal 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.
Interventions
External beam radiotherapy (EBRT) delivering a tumour absorbed dose of 20Gy in 5 fractions or 30Gy in 10 fractions.
Eligibility Criteria
You may qualify if:
- Histological confirmation of oesophageal carcinoma excluding small cell histology
- Not suitable for radical treatment (oesophagectomy or radical chemoradiotherapy) either because of patient choice or medical reasons
- Dysphagia clinically assessed as needing stent as primary treatment of the dysphagia
- Age 16 years or over
- Discussion and treatment decision for stent placement made by an upper GI multi-disciplinary team
- Clinician assessment of ability to attend for radiotherapy
- Expected survival of at least 12 weeks
- Written informed consent
- Patient has completed baseline Quality of Life Questionnaires (please note, as a minimum patients must have completed OG25)
You may not qualify if:
- Histology of small cell carcinoma type
- Tumour length of greater than 12 cm
- Tumour growth within 2 cm of the upper oesophageal sphincter
- Endoscopic treatment of the tumour, other than dilatation, planned in the peri-stent period
- Presence of a tracheo-oesophageal fistula
- Presence of a pacemaker in proposed radiotherapy field
- Previous radiotherapy to the area of the proposed radiotherapy field
- Planned endoscopic treatment of the tumour (e.g. laser) in the immediate peri-stenting period
- Female patient who is pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lisette Nixonlead
Study Sites (17)
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED, United Kingdom
Doncaster Royal Infirmary
Doncaster, England, DN2 5LT, United Kingdom
James Cook University Hospital
Middlesbrough, England, TS4 3BW, United Kingdom
George Eliot Hospital
Nuneaton, England, CV10 7DJ, United Kingdom
Conquest Hospital
Saint Leonards-on-Sea, England, TN37 7RD, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, England, S1O 2SJ, United Kingdom
Musgrove Park Hospital
Taunton, England, TA1 5DA, United Kingdom
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, SS0 0RY, United Kingdom
Weston General Hospital
Weston-super-Mare, England, BS23 4TQ, United Kingdom
Ninewells Hospital
Dundee, Scotland, DD1 9SY, United Kingdom
Ysbyty Gwynedd
Bangor, Wales, LL57 2PW, United Kingdom
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL, United Kingdom
Royal Gwent Hospital
Newport Gwent, Wales, NP9 2UB, United Kingdom
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, LL 18 5UJ, United Kingdom
Wrexham Maelor Hospital
Wrexham, Wales, LL13 7TD, United Kingdom
Weston Park Hospital
Sheffield, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Related Publications (2)
Adamson D, Blazeby J, Porter C, Hurt C, Griffiths G, Nelson A, Sewell B, Jones M, Svobodova M, Fitzsimmons D, Nixon L, Fitzgibbon J, Thomas S, Millin A, Crosby T, Staffurth J, Byrne A. Palliative radiotherapy combined with stent insertion to reduce recurrent dysphagia in oesophageal cancer patients: the ROCS RCT. Health Technol Assess. 2021 May;25(31):1-144. doi: 10.3310/hta25310.
PMID: 34042566DERIVEDAdamson D, Byrne A, Porter C, Blazeby J, Griffiths G, Nelson A, Sewell B, Jones M, Svobodova M, Fitzsimmons D, Nixon L, Fitzgibbon J, Thomas S, Millin A, Crosby T, Staffurth J, Hurt C. Palliative radiotherapy after oesophageal cancer stenting (ROCS): a multicentre, open-label, phase 3 randomised controlled trial. Lancet Gastroenterol Hepatol. 2021 Apr;6(4):292-303. doi: 10.1016/S2468-1253(21)00004-2. Epub 2021 Feb 19.
PMID: 33610215DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Senior Trial Manager
Study Record Dates
First Submitted
July 31, 2013
First Posted
August 5, 2013
Study Start
October 1, 2013
Primary Completion
November 1, 2018
Study Completion
November 1, 2018
Last Updated
June 4, 2019
Record last verified: 2019-06