An interventional study of Radiotherapy and Surgery in Merkel Cell Carcinoma, sponsored by University of Birmingham. Completed at 14 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by University of Birmingham · Not applicable, Interventional, and Treatment
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.
135 studies on the registry are indexed under Carcinoma, Merkel Cell; 37 are open to participants now.
This study's enrollment of 64 is above the median of 40 across 118 interventional studies indexed under Carcinoma, Merkel Cell.
Browse Carcinoma, Merkel Cell studies →University of Birmingham is the lead sponsor of 179 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
General Inclusion Criteria for All Patients:
Additional Inclusion Criteria for Rational Compare:
Exclusion Criteria:
Radical radiotherapy to macroscopic tumour and/or to the tumour bed if already excised, plus a wide margin.
Radiation: Radiotherapy
Wide Local Excision (WLE), aiming for complete excision of all MCC, plus a wide margin
Procedure: Surgery
Radiotherapy
Surgery
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
Time frame: Time from randomisation to 3 years
Plan to share: No
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University of Birmingham