Merkel Cell CarcinomaRational-MCCNCT05253144
Comparing Radical Surgery and Radical Radiotherapy as First Definitive Treatment for Primary MCC
A study testing Radiotherapy and Surgery in people with Merkel Cell Carcinoma, run by University of Birmingham at 14 sites in United Kingdom.
Trial summary
A randomised phase III multi-centre trial comparing radical surgery and radical radiotherapy as first definitive treatment for primary MCC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Merkel Cell Carcinoma
- What is being tested?
- Radiotherapy and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 14 sitesUnited Kingdom
- Study dates
- 19 Mar 2016to 13 Apr 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General Inclusion Criteria for All Patients:
- Patients newly diagnosed with histologically-proven MCC (either primary and/or regional nodal disease)
- Completion of clinical and radiological staging investigations, including CT imaging (or other modality) of regional nodal basin(s) and major viscera (and SLNB if clinically appropriate) to identify regional and distant metastases
- No confirmed distant metastases beyond the regional nodal basin (i.e. not stage IV disease)
- Suitable for radical treatment to achieve disease control
- Able to give valid informed consent
Show all 13Show fewer
- Consent for collection of data and tissue samples and follow up
- Life expectancy six months or greater in relation to general fitness and co-morbidities
- Additional Inclusion Criteria for Rational Compare:
- Patients newly diagnosed with histologically-proven primary MCC
- In the opinion of the SSMDT, the primary MCC can be encompassed both within a wide surgical margin and within a radiotherapy field, and the SSMDT is in equipoise regarding WLE or radiotherapy as first treatment
- A minimum margin of 1 cm surrounding the MCC achievable by either radiotherapy or surgery
- Consent for randomisation into Rational Compare
Who cannot join
- The primary MCC has already been treated radically with WLE (surgical margins >10 mm) or radiotherapy
- Intended use of regional or systemic chemotherapy for MCC (including molecularly targeted agents and immunotherapy)
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United Kingdom14 sites
University Hospital Birmingham NHS Foundation Trust
Birmingham
North Bristol NHS Trust
Bristol
Cambridge University Hospitals NHS Foundation Trust
Cambridge
NHS Tayside
Dundee
Barts Health NHS Trust
London
Christie NHS Foundation Trust
Manchester
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich
Nottingham University Hospitals NHS Trust
Nottingham
Oxford University Hospitals NHS Trust
Oxford
St Helens and Knowsley Hospitals NHS Trust
Prescot
Lancashire Teaching Hospitals NHS Foundation Trust
Preston
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
University Hospital of North Midlands Trust
Stoke-on-Trent
Royal Cornwall Hospitals NHS Trust
Truro
About this study
Official title: Rational-MCC: A Randomised Phase III Multi-centre Trial Comparing Radical Surgery and Radical Radiotherapy as First Definitive Treatment for Primary MCC
A randomised phase III multi-centre trial comparing radical surgery and radical radiotherapy as first definitive treatment for primary MCC
Read the detailed description
A randomised phase III multi-centre trial comparing radical surgery and radical radiotherapy as first definitive treatment for primary MCC with an observational study for patients ineligible for the randomised trial.
- Conditions
- Merkel Cell Carcinoma
- Being tested
- Radiotherapy, Surgery
- Medical subject headings
- Carcinoma, Merkel Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Radiotherapy
SurgeryProcedure or surgery
Surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Prioritise Radiotherapy | Experimental | Radical radiotherapy to macroscopic tumour and/or to the tumour bed if already excised, plus a wide margin. Receives: Radiation: Radiotherapy |
| Arm B: Prioritise Surgery | Experimental | Wide Local Excision (WLE), aiming for complete excision of all MCC, plus a wide margin Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to loco-regional failure
The time to loco regional failure for all patients is the time from randomisation to loco-regional treatment failure
Measured: Time from randomisation to 3 years
Secondary outcomes (7)
The proportion of patients alive and free of loco-regional disease
(irrespective of whether loco-regional failure has been previously demonstrated)
Measured: Time from randomisation to 3 years
Time to 'local failure'-the time from randomisation to macroscopic persistence, progression or recurrence between the primary site and regional nodal basin(s)
(including in-field and in transit metastases)
Measured: Time from randomisation to 3 years
Time to regional nodal failure
Time to regional nodal failure
Measured: Time from randomisation to 3 years
Time to distant progression
Time to distant progression
Measured: Time from randomisation to 3 years
Patient Progression free survival
Patient Progression free survival
Measured: Time from randomisation to 3 years
Patient survival
Survival from randomisation
Measured: Time from randomisation to 3 years
Quality of life assessed by questionnaires
Quality of life assessed by QLQC30/ EQ-5L-5D questionnaire completion
Measured: Time from randomisation to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start19 Mar 2016
- Primary completion22 Jan 2022
- Study completion13 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Merkel Cell CarcinomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase III
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Efficacy and Mechanism Evaluation (EME) Programme
- Responsible party
- Sponsor
- Investigators
- Neil Steven, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253144
- Sponsor's protocol ID
- RG_14-019
- Acronym
- Rational-MCC
- Status last verified
- May 2023
- First submitted
- 2 Nov 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rational-MCC: A Randomised Phase III Multi-centre Trial Comparing Radical Surgery and Radical Radiotherapy as First Definitive Treatment for Primary MCC
- ClinicalTrials.gov ID
- NCT05253144
- Acronym / sponsor ID
- Rational-MCC / RG_14-019
- Conditions
- Merkel Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Efficacy and Mechanism Evaluation (EME) Programme
- Study start
- 19 Mar 2016 (actual)
- Primary completion
- 22 Jan 2022 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 23 Feb 2022 (actual)
- 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.
A randomised phase III multi-centre trial comparing radical surgery and radical radiotherapy as first definitive treatment for primary MCC
Detailed description
A randomised phase III multi-centre trial comparing radical surgery and radical radiotherapy as first definitive treatment for primary MCC with an observational study for patients ineligible for the randomised trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase III
| Arm | Type | Receives |
|---|---|---|
| Arm A: Prioritise Radiotherapy | Experimental | Radiation: RadiotherapyRadical radiotherapy to macroscopic tumour and/or to the tumour bed if already excised, plus a wide margin. |
| Arm B: Prioritise Surgery | Experimental | Procedure: SurgeryWide Local Excision (WLE), aiming for complete excision of all MCC, plus a wide margin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients newly diagnosed with histologically-proven MCC (either primary and/or regional nodal disease)
- Completion of clinical and radiological staging investigations, including CT imaging (or other modality) of regional nodal basin(s) and major viscera (and SLNB if clinically appropriate) to identify regional and distant metastases
- No confirmed distant metastases beyond the regional nodal basin (i.e. not stage IV disease)
- Suitable for radical treatment to achieve disease control
- Able to give valid informed consent
Key exclusion criteria (2 listed)
- The primary MCC has already been treated radically with WLE (surgical margins >10 mm) or radiotherapy
- Intended use of regional or systemic chemotherapy for MCC (including molecularly targeted agents and immunotherapy)
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 |
|---|---|---|
| RadiotherapyRadiotherapy | Radiation | Arm A: Prioritise Radiotherapy |
| SurgerySurgery | Procedure or surgery | Arm B: Prioritise Surgery |
Primary outcome
Time to loco-regional failure
Time frame: Time from randomisation to 3 years
The time to loco regional failure for all patients is the time from randomisation to loco-regional treatment failure
7 secondary outcomes
The proportion of patients alive and free of loco-regional disease
Time frame: Time from randomisation to 3 years
Time to 'local failure'-the time from randomisation to macroscopic persistence, progression or recurrence between the primary site and regional nodal basin(s)
Time frame: Time from randomisation to 3 years
Time to regional nodal failure
Time frame: Time from randomisation to 3 years
Time to distant progression
Time frame: Time from randomisation to 3 years
Patient Progression free survival
Time frame: Time from randomisation to 3 years
Patient survival
Time frame: Time from randomisation to 3 years
Quality of life assessed by questionnaires
Time frame: Time from randomisation to 3 years
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 8 May 2024.
- Individual participant dataSharing planned: No
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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.
Neil Steven principal investigator
University of Birmingham
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy and Surgery in people with Merkel Cell Carcinoma, run by University of Birmingham at 14 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 13 inclusion and 2 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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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.
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?
Time to loco-regional failure (time frame: Time from randomisation to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2024.