A randomised phase III multi-centre trial comparing radical surgery and radical radiotherapy as first definitive treatment for primary MCC
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Radiotherapy
Surgery
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
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 frame: Time from randomisation to 3 years
The proportion of patients alive and free of loco-regional disease
(irrespective of whether loco-regional failure has been previously demonstrated)
Time frame: 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)
(including in-field and in transit metastases)
Time frame: Time from randomisation to 3 years
Time to regional nodal failure
Time to regional nodal failure
Time frame: Time from randomisation to 3 years
Time to distant progression
Time to distant progression
Time frame: Time from randomisation to 3 years
Patient Progression free survival
Patient Progression free survival
Time frame: Time from randomisation to 3 years
Patient survival
Survival from randomisation
Time frame: Time from randomisation to 3 years
Quality of life assessed by questionnaires
Quality of life assessed by QLQC30/ EQ-5L-5D questionnaire completion
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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
...and 4 more locations
Time frame: Time from randomisation to 3 years