Rational treatment selection for Merkel Cell Carcinoma (MCC)

Not Applicable

Completed

• Conditions: Merkel cell carcinoma; Cancer

• Registration Number: ISRCTN16290169
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-09
• Study Completion: 2020-09-30
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

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 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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time from randomisation to loco-regional treatment failure is determined from data collected throughout the study and up to 2 years of follow-up.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Progression free survival<br> 2. Proportion of patients alive and free of disease<br> 3. Quality of Life is measured at baseline, 3, 6, 9, 12 and 24 months from randomisation;<br> 4. Survival<br> 5. Time to distant progression<br> 6. Time to local failure<br> 7. Time to regional nodal failure<br>