Merkel Cell Carcinoma
Conditions
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.
Interventions
RADIATIONRadiotherapy
Radiotherapy
PROCEDURESurgery
Surgery
Sponsors
Efficacy and Mechanism Evaluation (EME) Programme
University of Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase III
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| Patient survival | Time from randomisation to 3 years | Survival from randomisation |
| Quality of life assessed by questionnaires | Time from randomisation to 3 years | Quality of life assessed by QLQC30/ EQ-5L-5D questionnaire completion |
| Patient Progression free survival | Time from randomisation to 3 years | Patient Progression free survival |
Countries
United Kingdom
Outcome results
None listed