Condition category
Cancer
Date applied
09/03/2016
Date assigned
09/03/2016
Last edited
28/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Public

Primary contact

Dr Rachel Blundred

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20444

Study information

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.

Acronym

Study hypothesis

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

15/WM/0454

Study design

Multi-centre phase III randomised parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Cancer; Subtopic: Cancer (Melanoma); Disease: Cancer (Melanoma)

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

Other

Phase

Phase III

Drug names

Primary outcome measures

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

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

Overall trial start date

31/03/2016

Overall trial end date

30/03/2021

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 400; UK Sample Size: 400

Participant 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)

Recruitment start date

31/03/2016

Recruitment end date

30/03/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University of Birmingham

Sponsor details

Cancer Research UK Clinical Trials Unit
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research council

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

28/10/2016: Cancer Help UK lay summary link added.