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.

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

Study Overview

• Status: Completed
• Conditions: Oesophageal Cancer
• Intervention / Treatment: Radiation: Radiotherapy

Detailed Description

The primary objective of the study is to 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.

Patients will be eligible to take part in the trial if they have oesophageal cancer, are in need of SEMS because of dysphagia, are aged 16 years or older, have been clinically assessed to be able to receive radiotherapy, have an expected survival of at least 12 weeks and are able to give written informed consent.

496 patients will be randomised to receive either SEMS alone or SEMS with radiotherapy. The radiotherapy will be given as an outpatient either as five treatments (one per day) over one week, or ten treatments over two weeks. Questionnaires will be completed before treatment, and at weeks two and four and then monthly for up to one year to assess quality of life and cost effectiveness. Interviews will be held with trial participants at three time points to explore their experiences while on the trial. Interviews will also be held with patients who do not consent to take part in the trial to explore their reasons for non-consent.

Treatments:

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.

There will also be a qualitative component of the trial will have two aims: i) to explore the feasibility of patients' recruitment to the trial and ii) to explore participants' experience of the trial interventions. It will examine their experience of consent and recruitment including reasons for declining, and examine patients' motivation to accept randomisation to an intervention which may include extra radiotherapy. This is an optional component and will require separate consent. Patients who do not consent to the trial, but who do consent to the qualitative component, will be interviewed about their reasons for not-consenting as soon as possible after the approach to participate.

Trial participants who consent to the qualitative component will be interviewed three times: at weeks one and four to capture initial decision-making thoughts and then after the interventions (week 8) to explore patients' experience of interventions and perceptions of benefit or detriment.

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • Sheffield, United Kingdom
    • Weston Park Hospital
  • Southampton, United Kingdom
    • Southampton General Hospital
  • England
    • Bristol, England, United Kingdom, BS2 8ED
      • Bristol Haematology and Oncology Centre
    • Doncaster, England, United Kingdom, DN2 5LT
      • Doncaster Royal Infirmary
    • Middlesbrough, England, United Kingdom, TS4 3BW
      • James Cook University Hospital
    • Nuneaton, England, United Kingdom, CV10 7DJ
      • George Eliot Hospital
    • Saint Leonards-on-Sea, England, United Kingdom, TN37 7RD
      • Conquest Hospital
    • Sheffield, England, United Kingdom, S1O 2SJ
      • Cancer Research Centre at Weston Park Hospital
    • Taunton, England, United Kingdom, TA1 5DA
      • Musgrove Park Hospital
    • Westcliff-On-Sea, England, United Kingdom, SS0 0RY
      • Southend University Hospital NHS Foundation Trust
    • Weston-super-Mare, England, United Kingdom, BS23 4TQ
      • Weston General Hospital
  • Scotland
    • Dundee, Scotland, United Kingdom, DD1 9SY
      • Ninewells Hospital
  • Wales
    • Bangor, Wales, United Kingdom, LL57 2PW
      • Ysbyty Gwynedd
    • Cardiff, Wales, United Kingdom, CF14 2TL
      • Velindre Cancer Center at Velindre Hospital
    • Newport Gwent, Wales, United Kingdom, NP9 2UB
      • Royal Gwent Hospital
    • Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
      • Glan Clwyd Hospital
    • Wrexham, Wales, United Kingdom, LL13 7TD
      • Wrexham Maelor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No 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.
Experimental: 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.	Radiation: Radiotherapy; External beam radiotherapy (EBRT) delivering a tumour absorbed dose of 20Gy in 5 fractions or 30Gy in 10 fractions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life	Assess the impact of combination treatment on core components of health related quality of life	within one year
overall survival	Assess the impact of radiotherapy in addition to SEMS placement on overall survival	one year
morbidity	Measure morbidity associated with the interventions	one year
re-intervention rate	Measure re-intervention rates	one year
cost	Assess the cost of the addition of radiotherapy to SEMS placement	one year

Collaborators and Investigators

• Sponsor: Lisette Nixon

Publications and helpful links

General Publications

• 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.
• 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. 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. Erratum In: Lancet Gastroenterol Hepatol. 2021 Apr;6(4):e3.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: July 31, 2013
• First Submitted That Met QC Criteria: July 31, 2013
• First Posted (Estimate): August 5, 2013

Study Record Updates

• Last Update Posted (Actual): June 4, 2019
• Last Update Submitted That Met QC Criteria: June 3, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: quality of life; Radiotherapy; stent
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: WCTU030; 10/50/49 (Other Grant/Funding Number: National Institute for Health Research Health Technology Assessment programme.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided