Oesophageal CancerPhase 3ROCSNCT01915693
ROCS (Radiotherapy After Oesophageal Cancer Stenting) Study
A Phase 3 study testing Radiotherapy in people with Oesophageal Cancer, run by Lisette Nixon at 17 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Oesophageal Cancer
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 17 sitesUnited Kingdom
- Study dates
- Oct 2013to Nov 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histological confirmation of oesophageal carcinoma excluding small cell histology
- Not suitable for radical treatment (oesophagectomy or radical chemoradiotherapy) either because of patient choice or medical reasons
- Dysphagia clinically assessed as needing stent as primary treatment of the dysphagia
- Age 16 years or over
- Discussion and treatment decision for stent placement made by an upper GI multi-disciplinary team
- Clinician assessment of ability to attend for radiotherapy
Show all 9Show fewer
- Expected survival of at least 12 weeks
- Written informed consent
- Patient has completed baseline Quality of Life Questionnaires (please note, as a minimum patients must have completed OG25)
Who cannot join
- Histology of small cell carcinoma type
- Tumour length of greater than 12 cm
- Tumour growth within 2 cm of the upper oesophageal sphincter
- Endoscopic treatment of the tumour, other than dilatation, planned in the peri-stent period
- Presence of a tracheo-oesophageal fistula
- Presence of a pacemaker in proposed radiotherapy field
Show all 9Show fewer
- Previous radiotherapy to the area of the proposed radiotherapy field
- Planned endoscopic treatment of the tumour (e.g. laser) in the immediate peri-stenting period
- Female patient who is pregnant
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United Kingdom17 sites
Ysbyty Gwynedd
Bangor, Wales, LL57 2PW
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL
Doncaster Royal Infirmary
Doncaster, England, DN2 5LT
Ninewells Hospital
Dundee, Scotland, DD1 9SY
James Cook University Hospital
Middlesbrough, England, TS4 3BW
Royal Gwent Hospital
Newport Gwent, Wales, NP9 2UB
George Eliot Hospital
Nuneaton, England, CV10 7DJ
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, LL 18 5UJ
Conquest Hospital
Saint Leonards-on-Sea, England, TN37 7RD
Cancer Research Centre at Weston Park Hospital
Sheffield, England, S1O 2SJ
Weston Park Hospital
Sheffield
Southampton General Hospital
Southampton
Musgrove Park Hospital
Taunton, England, TA1 5DA
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, SS0 0RY
Weston General Hospital
Weston-super-Mare, England, BS23 4TQ
Wrexham Maelor Hospital
Wrexham, Wales, LL13 7TD
About this study
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.
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
Read the 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.
- Conditions
- Oesophageal Cancer
- Being tested
- Radiotherapy
- Keywords
- Radiotherapy, stent, quality of life
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
External beam radiotherapy (EBRT) delivering a tumour absorbed dose of 20Gy in 5 fractions or 30Gy in 10 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Self-expanding metal stents (SEMS) (Control Arm) | No intervention | 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) | Experimental | 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. Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within one year
Secondary outcomes (5)
quality of life
Assess the impact of combination treatment on core components of health related quality of life
Measured: within one year
overall survival
Assess the impact of radiotherapy in addition to SEMS placement on overall survival
Measured: one year
morbidity
Measure morbidity associated with the interventions
Measured: one year
re-intervention rate
Measure re-intervention rates
Measured: one year
cost
Assess the cost of the addition of radiotherapy to SEMS placement
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oesophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lisette Nixon
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Lisette Nixon, Velindre NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915693
- Sponsor's protocol ID
- WCTU030
- Other IDs
- 10/50/49
- Acronym
- ROCS
- Status last verified
- Jun 2019
- First submitted
- 31 Jul 2013
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 34042566Adamson 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.
PubMed 33610215
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01915693
- Acronym / sponsor ID
- ROCS / WCTU030
- Conditions
- Oesophageal Cancer
- Keywords
- Radiotherapy, stent, quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Lisette NixonOther government
- Study start
- Oct 2013 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Self-expanding metal stents (SEMS) (Control Arm) | No intervention | –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) | Experimental | Radiation: RadiotherapyExternal 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Histological confirmation of oesophageal carcinoma excluding small cell histology
- Not suitable for radical treatment (oesophagectomy or radical chemoradiotherapy) either because of patient choice or medical reasons
- Dysphagia clinically assessed as needing stent as primary treatment of the dysphagia
- Age 16 years or over
- Discussion and treatment decision for stent placement made by an upper GI multi-disciplinary team
Key exclusion criteria (9 listed)
- Histology of small cell carcinoma type
- Tumour length of greater than 12 cm
- Tumour growth within 2 cm of the upper oesophageal sphincter
- Endoscopic treatment of the tumour, other than dilatation, planned in the peri-stent period
- Presence of a tracheo-oesophageal fistula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyExternal beam radiotherapy (EBRT) delivering a tumour absorbed dose of 20Gy in 5 fractions or 30Gy in 10 fractions. | Radiation | Arm B: SEMS plus external beam radiotherapy (Intervention Arm) |
Primary outcome
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.
5 secondary outcomes
quality of life
Time frame: within one year
overall survival
Time frame: one year
morbidity
Time frame: one year
re-intervention rate
Time frame: one year
cost
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Derived from this study: PubMed 34042566Adamson 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.
- Derived from this study: PubMed 33610215Adamson 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiotherapy in people with Oesophageal Cancer, run by Lisette Nixon at 17 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient-reported dysphagia (time frame: within one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01915693, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.