Clinical trial NCT05253144: Comparing Radical Surgery and Radical Radiotherapy as First Definitive Treatment for Primary MCC
Official title: Rational-MCC: A Randomised Phase III Multi-centre Trial Comparing Radical Surgery and Radical Radiotherapy as First Definitive Treatment for Primary MCC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Merkel Cell Carcinoma
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: Efficacy and Mechanism Evaluation (EME) Programme
First posted: 2022-02-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase III
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

General Inclusion Criteria for All Patients:

1. Patients newly diagnosed with histologically-proven MCC (either primary and/or regional nodal disease)
2. 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
3. No confirmed distant metastases beyond the regional nodal basin (i.e. not stage IV disease)
4. Suitable for radical treatment to achieve disease control
5. Able to give valid informed consent
6. Consent for collection of data and tissue samples and follow up
7. Life expectancy six months or greater in relation to general fitness and co-morbidities

Additional Inclusion Criteria for Rational Compare:

1. Patients newly diagnosed with histologically-proven primary MCC
2. 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
3. A minimum margin of 1 cm surrounding the MCC achievable by either radiotherapy or surgery
4. Consent for randomisation into Rational Compare

Exclusion Criteria:

1. The primary MCC has already been treated radically with WLE (surgical margins \>10 mm) or radiotherapy
2. Intended use of regional or systemic chemotherapy for MCC (including molecularly targeted agents and immunotherapy)

Primary outcomes:
measure: Time to loco-regional failure
timeFrame: Time from randomisation to 3 years
Secondary outcomes:
measure: The proportion of patients alive and free of loco-regional disease
timeFrame: Time from randomisation to 3 years
measure: Time to 'local failure'-the time from randomisation to macroscopic persistence, progression or recurrence between the primary site and regional nodal basin(s)
timeFrame: Time from randomisation to 3 years
measure: Time to regional nodal failure
timeFrame: Time from randomisation to 3 years
measure: Time to distant progression
timeFrame: Time from randomisation to 3 years
measure: Patient Progression free survival
timeFrame: Time from randomisation to 3 years
measure: Patient survival
timeFrame: Time from randomisation to 3 years
measure: Quality of life assessed by questionnaires
timeFrame: Time from randomisation to 3 years
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Dundee
country: United Kingdom
facility: NHS Tayside
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: Manchester
country: United Kingdom
facility: Christie NHS Foundation Trust
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
city: Prescot
country: United Kingdom
facility: St Helens and Knowsley Hospitals NHS Trust
city: Preston
country: United Kingdom
facility: Lancashire Teaching Hospitals NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospital of North Midlands Trust
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospitals NHS Trust
Study officials:
affiliation: University of Birmingham
name: Neil Steven
role: PRINCIPAL_INVESTIGATOR
References: