Merkel cell carcinoma Cancer
Conditions
Interventions
Participants are randomised to one of two study arms.
Arm A - Prioritise surgery: WLE of the primary site with radiotherapy reserved for later adjuvant treatment in selected patients.
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion 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 distant metastases beyond the regional nodal basin (i.e. not stage IV disease) 4. Being considered for radical treatment to achieve long term 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. Consent for randomisation into Rational Compare
Exclusion criteria
Exclusion criteria: Exclusion criteria for rational compare only: 1. The primary MCC has already been treated radically with WLE (surgical margins >10 mm) or RT 2. Intended use of regional or systemic chemotherapy (including molecularly targeted agents and immunotherapy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from randomisation to loco-regional treatment failure is determined from data collected throughout the study and up to 2 years of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression free survival 2. Proportion of patients alive and free of disease 3. Quality of Life is measured at baseline, 3, 6, 9, 12 and 24 months from randomisation; 4. Survival 5. Time to distant progression 6. Time to local failure 7. Time to regional nodal failure | — |
Countries
England, United Kingdom
Contacts
Public ContactRachel Blundred
Outcome results
None listed