Radiotherapy after Oesophageal Cancer Stenting (ROCS) study | Recruiting
Radiotherapy after Oesophageal Canc... | Recruiting
Radiotherapy after Oesophageal Cancer Stenting (ROCS) study
ROCS

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Medical Conditions
  • Oesophageal cancer requiring stent for relief of dysphagia
Primary Contact Details
Dr Douglas Adamson
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
ISRCTN12376468
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
http://www.cancerresearchuk.org/cancer-help/trials/a-trial-looking-radiotherapy-oesophageal-cancer-difficulty-swallowing-rocs
Research Details
  • 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
Phase
Not Applicable
Study Design
Two-arm open randomised phase III trial with a 1:1 randomisation ratio. A qualitative component in a sub-set of patients.
Study Type
Interventional
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
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
Publication(s)
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25336193
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
496
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 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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Dundee
DD1 9SY
Trial Contact(s)
Primary Trial Contact
Dr Douglas Adamson
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
EudraCT Number
Sorry, this information is not available
Funder(s)
  • NIHR Health Technology Assessment Programme - HTA (UK), 10/50/49
Other Study ID Numbers
HTA 10/50/49, WCTU030
Sponsor(s)
Velindre NHS Trust (UK)
Key Dates

Recruitment Start Date

01 Oct 2012

Recruitment End Date

30 Sep 2018

Trial Start Date

01 Oct 2012

Trial End Date

30 Sep 2018

Date added to source

10 Jul 2012

Date updated in source

31 Oct 2014