Radiotherapy after Oesophageal Cancer Stenting (ROCS) study

Conditions

Oesophageal cancer requiring stent for relief of dysphagia Cancer Malignant neoplasm of oesophagus

Douglas Adamson, Jane Blazeby, Catharine Porter, Chris Hurt, Gareth Griffiths et al. (17 authors)

Health Technology Assessment2021-05-015 citations

Palliative radiotherapy after oesophageal cancer stenting (ROCS): a multicentre, open-label, phase 3 randomised controlled trial.

Adamson 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.

2021-02-1925 citations

10.1016/s2468-1253(21)00004-2

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 protocol for a randomized controlled trial.

Adamson D, Blazeby J, Nelson A, Hurt C, Nixon L, Fitzgibbon J, Crosby T, Staffurth J, Evans M, Kelly NH, Cohen D, Griffiths G, Byrne A.

2014-10-2215 citations

10.1186/1745-6215-15-402

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Scotland, United Kingdom

Contacts

Public ContactMartina Svobodova

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

Outcome results

None listed