Rational treatment selection for Merkel Cell Carcinoma (MCC)

ISRCTN	ISRCTN16290169
DOI	https://doi.org/10.1186/ISRCTN16290169
Protocol serial number	20444
Sponsor	University of Birmingham
Funder	Medical Research Council

Submission date: 09/03/2016
Registration date: 09/03/2016
Last edited: 10/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-improving-usual-treatment-newly-diagnosed-merkel-cell-cancer-rational-compare-trial-rational-review-study

Contact information

Dr Rachel Blundred
Public

University of Birmingham
Institute for Cancer Studies
Edgbaston
Birmingham
B15 2TT
United Kingdom

Phone	+44 121 414 3792
Email	rationalmcc@trials.bham.ac.uk

Study information

Primary study design	Interventional
Study design	Multi-centre phase III randomised parallel trial
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
Scientific 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.
Study objectives	The aim of this study is to determine if radical surgery or radical radiotherapy as first definitive treatment for the primary merkel cell carcinoma (MCC) results in better control of loco-regional disease.
Ethics approval(s)	15/WM/0454
Health condition(s) or problem(s) studied	Merkel cell carcinoma
Intervention	Participants are randomised to one of two study arms. Arm A - Prioritise surgery: WLE of the primary site with radiotherapy reserved for later adjuvant treatment in selected patients. Arm B - Prioritise radiotherapy: Early use of radical radiotherapy to the primary site without prior radical surgery.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Time from randomisation to loco-regional treatment failure is determined from data collected throughout the study and up to 2 years of follow-up.
Key secondary outcome measure(s)	1. Progression free survival 2. Proportion of patients alive and free of disease 3. Quality of Life is measured at baseline, 3, 6, 9, 12 and 24 months from randomisation; 4. Survival 5. Time to distant progression 6. Time to local failure 7. Time to regional nodal failure
Completion date	30/09/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	400
Key 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
Key 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)
Date of first enrolment	31/03/2016
Date of final enrolment	30/12/2018

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Birmingham

Institute for Cancer Studies
Edgbaston
Birmingham
B15 2TT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
IPD sharing plan	All data generated or analysed during this study will be included in the subsequent results publication

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version 4.0	11/01/2019	10/10/2022	No	No

Additional files

ISRCTN16290169_Protocol_v4.0_11Jan2019.pdf: Protocol file

Editorial Notes

10/10/2022: Protocol file uploaded.
09/03/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/03/2021 to 30/12/2018.
2. The overall end date was changed from 30/03/2021 to 30/09/2020.
3. The intention to publish date was changed from 30/03/2022 to 14/03/2022.
4. The publication and dissemination plan was added.
5. The participant level data sharing plan was added.
09/07/2020: The trial contact details have been made publicly visible.
02/04/2019: The condition has been changed from "Topic: Cancer; Subtopic: Cancer (Melanoma); Disease: Cancer (Melanoma)" to "Merkel cell carcinoma" following a request from the NIHR.
01/11/2017: Internal review.
28/10/2016: Cancer Help UK lay summary link added.