Clinical trial · Interventional
ROCS (Radiotherapy After Oesophageal Cancer Stenting) Study
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oesophageal Cancer | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Arm A: Self-expanding metal stents (SEMS) (Control Arm)
- description
- 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.
- type
- EXPERIMENTAL
- label
- Arm B: SEMS plus external beam radiotherapy (Intervention Arm)
- description
- 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.
- interventionNames
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- patient-reported dysphagia
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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 stent 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 9. Patient has completed baseline Quality of Life Questionnaires (please note, as a minimum patients must have completed OG25) 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 in proposed radiotherapy field 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. Female patient who is pregnant
References
Publications (2)
- DERIVEDAdamson 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 34042566
- DERIVEDAdamson 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 33610215