Comparing Radical Surgery and Radical Radiotherapy as First Definitive Treatment for Primary MCC

Not Applicable

Completed

• Conditions: Merkel Cell Carcinoma
• Interventions: Radiation: Radiotherapy; Procedure: Surgery

• Registration Number: NCT05253144
• Lead Sponsor: University of Birmingham

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.

Study Timeline

• Study Start: 2016-03-19
• Study First Submitted: 2021-11-02
• Primary Completion: 2022-01-22
• Study First Submitted QC: 2022-02-14
• Study First Posted: 2022-02-23
• Study Completion: 2023-04-13
• Status Verified: 2023-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: Prioritise Radiotherapy	Radiotherapy	Radical radiotherapy to macroscopic tumour and/or to the tumour bed if already excised, plus a wide margin.
Arm B: Prioritise Surgery	Surgery	Wide Local Excision (WLE), aiming for complete excision of all MCC, plus a wide margin

Primary Outcome Measures

Name	Time	Method
Time to loco-regional failure	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

Secondary Outcome Measures

Name	Time	Method
Patient survival	Time from randomisation to 3 years	Survival from randomisation
Time to 'local failure'-the time from randomisation to macroscopic persistence, progression or recurrence between the primary site and regional nodal basin(s)	Time from randomisation to 3 years	(including in-field and in transit metastases)
Time to regional nodal failure	Time from randomisation to 3 years	Time to regional nodal failure
Time to distant progression	Time from randomisation to 3 years	Time to distant progression
Patient Progression free survival	Time from randomisation to 3 years	Patient Progression free survival
Quality of life assessed by questionnaires	Time from randomisation to 3 years	Quality of life assessed by QLQC30/ EQ-5L-5D questionnaire completion
The proportion of patients alive and free of loco-regional disease	Time from randomisation to 3 years	(irrespective of whether loco-regional failure has been previously demonstrated)

Trial Locations

Locations (14)

Cambridge University Hospitals NHS Foundation Trust; 🇬🇧 Cambridge, United Kingdom

Nottingham University Hospitals NHS Trust; 🇬🇧 Nottingham, United Kingdom

University Hospital of North Midlands Trust; 🇬🇧 Stoke-on-Trent, United Kingdom

Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom

University Hospital Birmingham NHS Foundation Trust; 🇬🇧 Birmingham, United Kingdom

North Bristol NHS Trust; 🇬🇧 Bristol, United Kingdom

NHS Tayside; 🇬🇧 Dundee, United Kingdom

Norfolk and Norwich University Hospitals NHS Foundation Trust; 🇬🇧 Norwich, United Kingdom

St Helens and Knowsley Hospitals NHS Trust; 🇬🇧 Prescot, United Kingdom

Oxford University Hospitals NHS Trust; 🇬🇧 Oxford, United Kingdom

Lancashire Teaching Hospitals NHS Foundation Trust; 🇬🇧 Preston, United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust; 🇬🇧 Sheffield, United Kingdom

Barts Health NHS Trust; 🇬🇧 London, United Kingdom

Royal Cornwall Hospitals NHS Trust; 🇬🇧 Truro, United Kingdom