Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

ROCS (Radiotherapy After Oesophageal Cancer Stenting) Study (ROCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01915693
Recruitment Status : Active, not recruiting
First Posted : August 5, 2013
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Lisette Nixon, Velindre NHS Trust

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Oesophageal Cancer Radiation: Radiotherapy Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : October 2013
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. patient-reported dysphagia [ Time Frame: within one year ]
    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. quality of life [ Time Frame: within one year ]
    Assess the impact of combination treatment on core components of health related quality of life

  2. overall survival [ Time Frame: one year ]
    Assess the impact of radiotherapy in addition to SEMS placement on overall survival

  3. morbidity [ Time Frame: one year ]
    Measure morbidity associated with the interventions

  4. re-intervention rate [ Time Frame: one year ]
    Measure re-intervention rates

  5. cost [ Time Frame: one year ]
    Assess the cost of the addition of radiotherapy to SEMS placement



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01915693


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

Layout table for additonal information
Responsible Party: Lisette Nixon, Senior Trial Manager, Velindre NHS Trust
ClinicalTrials.gov Identifier: NCT01915693     History of Changes
Other Study ID Numbers: WCTU030
10/50/49 ( Other Grant/Funding Number: National Institute for Health Research Health Technology Assessment programme. )
First Posted: August 5, 2013    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Lisette Nixon, Velindre NHS Trust:
Radiotherapy
stent
quality of life

Additional relevant MeSH terms:
Layout table for MeSH terms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases