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

June 3, 2019 updated by: Lisette Nixon

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
within one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
quality of life
Time Frame: within one year
Assess the impact of combination treatment on core components of health related quality of life
within one year
overall survival
Time Frame: one year
Assess the impact of radiotherapy in addition to SEMS placement on overall survival
one year
morbidity
Time Frame: one year
Measure morbidity associated with the interventions
one year
re-intervention rate
Time Frame: one year
Measure re-intervention rates
one year
cost
Time Frame: one year
Assess the cost of the addition of radiotherapy to SEMS placement
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lisette Nixon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oesophageal Cancer

Clinical Trials on Radiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings