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.

niversity of Birmingham0 个研究点目标入组 400 人开始时间: 2016年3月9日最近更新: 2022年10月24日

适应症

试验速览

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•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 distant metastases beyond the regional nodal basin (i.e. not stage IV disease)
•4. Being considered for radical treatment to achieve long term 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. Consent for randomisation into Rational Compare

•Exclusion criteria for rational compare only:
•1. The primary MCC has already been treated radically with WLE (surgical margins >10 mm) or RT
•2. Intended use of regional or systemic chemotherapy (including molecularly targeted agents and immunotherapy)

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