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

NCT05253144 | Completed DMC

• 1 other identifier: RG_14-019
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 14

Brief Summary

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

Conditions

Merkel Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The proportion of patients alive and free of loco-regional disease

  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 from randomisation to 3 years

• Time to regional nodal failure

  Time from randomisation to 3 years

• Time to distant progression

  Time from randomisation to 3 years

• Patient Progression free survival

  Time from randomisation to 3 years

Study Arms (2)

Arm A: Prioritise Radiotherapy

EXPERIMENTAL

Radical radiotherapy to macroscopic tumour and/or to the tumour bed if already excised, plus a wide margin.

Radiation: Radiotherapy

Arm B: Prioritise Surgery

EXPERIMENTAL

Wide Local Excision (WLE), aiming for complete excision of all MCC, plus a wide margin

Procedure: Surgery

Interventions

Radiotherapy RADIATION

Radiotherapy

Arm A: Prioritise Radiotherapy

Surgery PROCEDURE

Surgery

Arm B: Prioritise Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Birmingham: lead
• Efficacy and Mechanism Evaluation (EME) Programme: collaborator

Study Sites (14)

University Hospital Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Location

North Bristol NHS Trust

Bristol, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Location

NHS Tayside

Dundee, United Kingdom

Location

Barts Health NHS Trust

London, United Kingdom

Location

Christie NHS Foundation Trust

Manchester, United Kingdom

Location

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Location

Oxford University Hospitals NHS Trust

Oxford, United Kingdom

Location

St Helens and Knowsley Hospitals NHS Trust

Prescot, United Kingdom

Location

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

Location

University Hospital of North Midlands Trust

Stoke-on-Trent, United Kingdom

Location

Royal Cornwall Hospitals NHS Trust

Truro, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Merkel Cell

Interventions

Radiotherapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Neil Steven

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase III

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: February 23, 2022
• Study Start: March 19, 2016
• Primary Completion: January 22, 2022
• Study Completion: April 13, 2023
• Last Updated: May 8, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (14)