Rational MCC, Vn1.0, 4th November 2015

• Research type

  Research Study

• Full title

  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.

• IRAS ID

  179387

• Contact name

  Neil Steven

• Contact email

  n.m.steven@bham.ac.uk

• Sponsor organisation

  University of Birmingham

• ISRCTN Number

  ISRCTN16290169

• Clinicaltrials.gov Identifier

  SK3008, CAS Number

• Duration of Study in the UK

  8 years, 0 months, 1 days

• Research summary

  Research Summary
  Merkel cell carcinoma (MCC) is rare but greatly impacts on patients. It starts on skin (the primary), grows fast and often spreads. Spread to other organs is usually fatal. It must be treated effectively or it rapidly regrows. MCC can be treated by surgery called wide local excision (WLE) and is responsive to radiotherapy. In WLE, surgeons remove the primary with margin to reduce the chance of leaving behind satellite tumours. Sometimes radiotherapy is used after WLE to kill residual cancer. Radiotherapy to the primary with a margin can control MCC without prior extensive surgery. There are no trials to help decide whether it is best to use radiotherapy first or WLE. \n\nRational MCC aims to provide this evidence and has two components, Rational Compare and Rational Review. In Rational Compare, the patient and specialists must believe that either WLE or radiotherapy could be equally effective as first treatment. These patients will be randomised to either treatment. Alternatively, patients will enter Rational Review if one of the treatments in particular is preferred.\n \nAssessments will be for 2 years: not many MCC recur later. Patients will be assessed every 3 months and have a CT-PET at the end of year 1 and 2. Patients’ quality of life will be measured by questionnaires in Rational Compare. All patients in the trial will provide data, blood samples and a section from the routine biopsy. \n\nRational Compare will provide evidence about the chances that either WLE or radiotherapy as first treatment for the skin primary will prevent re-appearance of the cancer, and how well the treatments are tolerated. Data from all patients will help us decide whether regular scans help detect the cancer if it re-appears. Also we will look for features that can identify a patient who needs more or less intensive treatment.
  Summary of results
  Sixty-four patients were recruited of whom 5 were randomised. The trial did not meet its feasibility target for randomisation and closed early. The five randomised patients all underwent their allocated treatment (3 radiotherapy and 2 surgery) and none experienced recurrence during the trial.
  In conclusion, both surgery and radiotherapy continue to be offered as first line treatment for primary MCC in UK practice, but it is still uncertain whether one should be prioritised.

  How has this study helped patients and researchers?

  It is hoped that this trial will help with the design of future research to help people with rare cancers and the researchers have been able to make some recommendations for future research in this group of patients.

  The trial still collected useful data along with blood immune measurements, plus tumour samples, from this rare group of patients for further study. This trial will help with design of future research to help people with rare cancer.

  Details of any further research planned.
  None currently.

  Where can I learn more about this study?

  To learn about this trial, you can find more detailed information on the clinical.trials.gov;
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT05253144%2FNBTI%2FBRq2AQ%2FAQ%2F7df4afd2-052e-4836-93c4-20ed4f89b04b%2F1%2F4IZjyjXWM-&data=05%7C02%7Csolihull.rec%40hra.nhs.uk%7C751b53d6df4d4d3a864f08dc9055b5da%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638543944997784770%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=SbFltdPqowLiO%2FGqgk%2FVluv8nQ7nhO%2Fx5sUn07QWZek%3D&reserved=0

  A summary is also provided on the Cancer Research UK website.
  A trial looking at improving usual treatment for newly diagnosed Merkel cell cancer (Rational Compare trial and Rational Review study) | Cancer Research UK

• REC name

  West Midlands - Solihull Research Ethics Committee

• REC reference

  15/WM/0454

• Date of REC Opinion

  29 Jan 2016

• REC opinion

  Further Information Favourable Opinion