Condition category
Cancer
Date applied
04/07/2012
Date assigned
10/07/2012
Last edited
31/10/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Dr Douglas Adamson

ORCID ID

Contact details

Ward 32
Ninewells Hosptial
Dundee
DD1 9SY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 10/50/49, WCTU030

Study information

Scientific title

Palliative radiotherapy in addition to self-expanding metal stent for improving dysphagia and survival in advanced oesophageal cancer: Radiotherapy after Oesophageal Cancer Stenting (ROCS) study

Acronym

ROCS

Study hypothesis

Radiotherapy in addition to self-expanding metal stent (SEMS) placement improves patient-reported dysphagia and increases time to progression in a patient population unable to undergo surgery.

More details can be found at http://www.nets.nihr.ac.uk/projects/hta/105049
Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0009/81666/PRO-10-50-49.pdf

Ethics approval

Not provided at time of registration

Study design

Two-arm open randomised phase III trial with a 1:1 randomisation ratio. A qualitative component in a sub-set of patients.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Oesophageal cancer requiring stent for relief of dysphagia

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.

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 outcome measures

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

Overall trial start date

01/10/2012

Overall trial end date

30/09/2018

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

496

Participant 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

Recruitment start date

01/10/2012

Recruitment end date

30/09/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ward 32
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

Velindre NHS Trust (UK)

Sponsor details

Mrs Sarah Townsend
Research & Development Office
Velindre NHS Trust
3rd Floor
14 Cathedral Road
Cardiff
CF11 9LJ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK), 10/50/49

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25336193

Publication citations

  1. Protocol

    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, 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., Trials, 2014, 15, 1, 402, doi: 10.1186/1745-6215-15-402.

Additional files

Editorial Notes