Radiotherapy after Oesophageal Cancer Stenting (ROCS) study

Not Applicable

Completed

• Conditions: Oesophageal cancer requiring stent for relief of dysphagia; Cancer; Malignant neoplasm of oesophagus

• Registration Number: ISRCTN12376468
• Lead Sponsor: Velindre NHS Trust (UK)

Brief Summary

2014 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/25336193 protocol 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33610215/ results (added 22/02/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34042566/ (added 28/05/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-10
• Study Completion: 2018-11-30
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 220

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified