Clinical trial · Interventional
Comparing Radical Surgery and Radical Radiotherapy as First Definitive Treatment for Primary MCC
Rational-MCC: A Randomised Phase III Multi-centre Trial Comparing Radical Surgery and Radical Radiotherapy as First Definitive Treatment for Primary MCC
NCT05253144CI-TRIAL-00076888Rational-MCCcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A randomised phase III multi-centre trial comparing radical surgery and radical radiotherapy as first definitive treatment for primary MCC
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Merkel Cell Carcinoma | Merkel Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Prioritise Radiotherapy
- description
- Radical radiotherapy to macroscopic tumour and/or to the tumour bed if already excised, plus a wide margin.
- interventionNames
- Radiation: Radiotherapy
- type
- EXPERIMENTAL
- label
- Arm B: Prioritise Surgery
- description
- Wide Local Excision (WLE), aiming for complete excision of all MCC, plus a wide margin
- interventionNames
- Procedure: Surgery
Primary outcomes (1)
- measure
- Time to loco-regional failure
- timeFrame
- Time from randomisation to 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.