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

Merkel Cell Carcinoma Clinical Trial

— Rational-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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05253144
• Other study ID #: RG_14-019
• Status: Completed
• Phase: N/A
• Start date: March 19, 2016
• Est. completion date: April 13, 2023

Study information

• Verified date: May 2023
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomised phase III multi-centre trial comparing radical surgery and radical radiotherapy as first definitive treatment for primary MCC

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 13, 2023
• Est. primary completion date: January 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Merkel Cell
• Merkel Cell Carcinoma

Intervention

Radiation:
• Radiotherapy
Radiotherapy

Procedure:
• Surgery
Surgery

Locations

Country	Name	City	State
United Kingdom	University Hospital Birmingham NHS Foundation Trust	Birmingham
United Kingdom	North Bristol NHS Trust	Bristol
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	NHS Tayside	Dundee
United Kingdom	Barts Health NHS Trust	London
United Kingdom	Christie NHS Foundation Trust	Manchester
United Kingdom	Norfolk and Norwich University Hospitals NHS Foundation Trust	Norwich
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	Oxford University Hospitals NHS Trust	Oxford
United Kingdom	St Helens and Knowsley Hospitals NHS Trust	Prescot
United Kingdom	Lancashire Teaching Hospitals NHS Foundation Trust	Preston
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield
United Kingdom	University Hospital of North Midlands Trust	Stoke-on-Trent
United Kingdom	Royal Cornwall Hospitals NHS Trust	Truro

Sponsors (2)

Lead Sponsor	Collaborator
University of Birmingham	Efficacy and Mechanism Evaluation (EME) Programme

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to loco-regional failure	The time to loco regional failure for all patients is the time from randomisation to loco-regional treatment failure	Time from randomisation to 3 years
Secondary	The proportion of patients alive and free of loco-regional disease	(irrespective of whether loco-regional failure has been previously demonstrated)	Time from randomisation to 3 years
Secondary	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)	Time from randomisation to 3 years
Secondary	Time to regional nodal failure	Time to regional nodal failure	Time from randomisation to 3 years
Secondary	Time to distant progression	Time to distant progression	Time from randomisation to 3 years
Secondary	Patient Progression free survival	Patient Progression free survival	Time from randomisation to 3 years
Secondary	Patient survival	Survival from randomisation	Time from randomisation to 3 years
Secondary	Quality of life assessed by questionnaires	Quality of life assessed by QLQC30/ EQ-5L-5D questionnaire completion	Time from randomisation to 3 years