{"registry": "ISRCTN", "registryId": "ISRCTN16290169", "source": "https://www.isrctn.com/ISRCTN16290169", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN16290169/format/default", "fetchedAt": "2026-10-07T17:01:28.366581Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "Rational treatment selection for Merkel Cell Carcinoma (MCC)", "scientificTitle": "Rational treatment selection for Merkel Cell Carcinoma (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.", "acronym": "", "hypothesis": "The aim of this study is to determine if radical surgery or radical radiotherapy as first definitive treatment\nfor the primary merkel cell carcinoma (MCC) results in better control of loco-regional disease.", "primaryOutcome": "Time from randomisation to loco-regional treatment failure is determined from data collected throughout the study and up to 2 years of follow-up.", "secondaryOutcome": "1. Progression free survival\n2. Proportion of patients alive and free of disease\n3. Quality of Life is measured at baseline, 3, 6, 9, 12 and 24 months from randomisation; \n4. Survival\n5. Time to distant progression\n6. Time to local failure\n7. Time to regional nodal failure", "intervention": "\n\tParticipants are randomised to one of two study arms.\n\nArm A - Prioritise surgery: WLE of the primary site with radiotherapy reserved for later adjuvant treatment in selected patients.\nArm B - Prioritise radiotherapy: Early use of radical radiotherapy to the primary site without prior radical surgery.\n\tProcedure/Surgery\n\t\n\t\n      ", "condition": "\n\tMerkel cell carcinoma\n\tCancer\n\t\n      ", "studyDesign": "Multi-centre phase III randomised parallel trial", "overallEndDate": "2020-09-30T00:00:00.000Z", "clinicalTrialsGovNumber": "", "lastUpdated": "2022-10-10T08:32:16.276063Z", "eligibility": {"inclusion": "General inclusion criteria for all patients:\n1. Patients newly diagnosed with histologically-proven MCC (either primary and/or regional nodal disease)\n2. 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\n3. No distant metastases beyond the regional nodal basin (i.e. not stage IV disease)\n4. Being considered for radical treatment to achieve long term disease control \n5. Able to give valid informed consent \n6. Consent for collection of data and tissue samples and follow up.\n7. Life expectancy six months or greater in relation to general fitness and co-morbidities\n\nAdditional inclusion criteria for rational compare:\n1. Patients newly diagnosed with histologically-proven primary MCC\n2. 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\n3. Consent for randomisation into Rational Compare", "exclusion": "Exclusion criteria for rational compare only: \n1. The primary MCC has already been treated radically with WLE (surgical margins >10 mm) or RT\n2. Intended use of regional or systemic chemotherapy (including molecularly targeted agents and immunotherapy)", "ageRange": "Adult", "gender": "All", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "2016-03-31T00:00:00.000Z", "recruitmentEnd": "2018-12-30T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "400", "totalFinalEnrolment": ""}, "countries": ["United Kingdom", "England"], "locations": [{"name": "University of Birmingham", "city": "Birmingham", "state": "", "country": "United Kingdom", "zip": "B15 2TT"}], "sponsors": [{"organisation": "University of Birmingham", "sponsorType": "Hospital/treatment centre", "rorId": "https://ror.org/03angcq70"}], "funders": [{"name": "Medical Research Council", "fundRef": "http://dx.doi.org/10.13039/501100000265"}]}, "studySha256": "ca337fb57f04001320c04adbc6ad8f674b4c8b81bd77dfd4eca9a4eda5e54216"}