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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02385214




Registration number
NCT02385214
Ethics application status
Date submitted
13/06/2014
Date registered
11/03/2015
Date last updated
14/04/2022

Titles & IDs
Public title
MelmarT Melanoma Margins Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma
Scientific title
A Phase III, Multi-centre, Multi-national Randomised Control Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma
Secondary ID [1] 0 0
03.12
Universal Trial Number (UTN)
Trial acronym
MelMarT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous Melanoma by AJCC V7 Stage 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Wide Local Excision = 1cm Margin
Treatment: Surgery - Wide Local Excision = 2cm Margin

Experimental: Arm A Wide Local Excision = 1cm Margin - ARM A: Experimental Arm Wide Local Excision = 1cm Margin + Sentinel Lymph Node Biopsy

+/- Reconstruction

Active comparator: Arm B Wide Local Excision = 2cm Margin - ARM B:Control Arm Wide Local Excision = 2cm Margin + Sentinel Lymph Node Biopsy

+/- Reconstruction


Treatment: Surgery: Wide Local Excision = 1cm Margin
A wide local excision involves removing an extra "safety margin" of healthy skin surrounding the original melanoma site to ensure that any remaining scattered melanoma tumour cells are removed that may have been left behind after the first initial biopsy/surgery.

Treatment: Surgery: Wide Local Excision = 2cm Margin
A wide local excision involves removing an extra "safety margin" of healthy skin surrounding the original melanoma site to ensure that any remaining scattered melanoma tumour cells are removed that may have been left behind after the first initial biopsy/surgery.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Local Melanoma Recurrence (Melanoma Specific Survival)
Timepoint [1] 0 0
0-120 months
Secondary outcome [1] 0 0
Recurrence-Free Survival
Timepoint [1] 0 0
0-120 months
Secondary outcome [2] 0 0
QoL and neuropathic pain assessments Neuropathic Pain (PainDetect)
Timepoint [2] 0 0
Baseline, 3, 6 12, 24 & 60 months.
Secondary outcome [3] 0 0
Overall Survival
Timepoint [3] 0 0
0-120 Months
Secondary outcome [4] 0 0
Adverse events
Timepoint [4] 0 0
Within 1 year
Secondary outcome [5] 0 0
Surgery related adverse events
Timepoint [5] 0 0
Up to 30 days from randomisation
Secondary outcome [6] 0 0
Health System Resource Use
Timepoint [6] 0 0
Baseline, 3, 6, 12, 24 and 60 months

Eligibility
Key inclusion criteria
1. Patients must have a primary invasive cutaneous melanoma of Breslow thickness greater than 1 millimetre as determined by diagnostic biopsy (narrow excision, incision or punch biopsy) and subsequent histopathological analysis.
2. Patients must have had the invasive primary completely excised, including any in situ component but excluding melanocytic atypia, with a narrow margin, either in one stage or more than one stage in the case where an incision or punch biopsy has previously been performed. This information, including measured margins of lateral and deep clearance must be documented on the pathology report.
3. Must have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm, sole).
4. An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary melanoma.
5. Randomisation and the primary study intervention, including staging sentinel node biopsy, must be completed by 120 days of original diagnosis.
6. Patients must be 18 years or older at time of consent.
7. Patient must be able to give informed consent and comply with the treatment protocol and follow-up plan.
8. Life expectancy of at least 10 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI.
9. Patients must have an ECOG performance score between 0 and 1.
10. A survivor of prior cancer is eligible provided that ALL of the following criteria are met and documented:

* The patient has undergone potentially curative therapy for all prior malignancies,
* There has been no evidence of recurrence of any prior malignancies for at least FIVE years (except for successfully treated cervical or non-melanoma skin cancer with no evidence of recurrence), and
* The patient is deemed by their treating physician to be at low risk of recurrence from previous malignancies.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Uncertain diagnosis of melanoma i.e. so-called 'melanocytic lesion of unknown malignant potential'.
2. Patient has already undergone wide local excision at the site of the primary index lesion.
3. Patient unable or ineligible to undergo staging sentinel lymph node biopsy of the primary index lesion.
4. Desmoplastic or neurotropic melanoma.
5. Microsatellitosis as per AJCC 2009 definition
6. Subungual melanoma
7. Patient has already undergone a local flap reconstruction of the defect after excision of the primary and determination of an accurate excision margin is impossible.
8. History of previous or concurrent (i.e., second primary) invasive melanoma.
9. Melanoma located distal to the metacarpophalangeal joint, on the tip of the nose, the eyelids or on the ear, mucous membranes or internal viscera.
10. Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma.
11. Patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, including sentinel lymph node biopsy, of the index melanoma.
12. Any additional solid tumour or hematologic malignancy during the past 5 years except T1 skin lesions of squamous cell carcinoma, basal cell carcinoma, or uterine/cervical cancer.
13. Melanoma-related operative procedures not corresponding to criteria described in the protocol.
14. Planned adjuvant radiotherapy to the primary melanoma site after Wide Local Excision is not permitted as part of the protocol and any patients given this treatment would be excluded from the study.
15. History of organ transplantation.
16. Oral or parenteral immunosuppressive agents (not topical or inhaled steroids) at any time during study participation or within 6 months prior to enrolment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/08/2026
Actual
Sample size
Target
Accrual to date
Final
400
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Melanoma Institute Australia - Poche Centre - North Sydney
Recruitment hospital [2] 0 0
Gold Coast Melanom Clinic - Coolangatta
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre Division of Cancer Surgery - Melbourne
Recruitment hospital [4] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2060 - North Sydney
Recruitment postcode(s) [2] 0 0
4225 - Coolangatta
Recruitment postcode(s) [3] 0 0
3002 - Melbourne
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Pennsylvania
Country [2] 0 0
Canada
State/province [2] 0 0
Toronto
Country [3] 0 0
Sweden
State/province [3] 0 0
Göteborg
Country [4] 0 0
United Kingdom
State/province [4] 0 0
England
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Essex
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Mersyside
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Oxford
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Bristol
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Cambridge
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Exeter
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Leeds
Country [12] 0 0
United Kingdom
State/province [12] 0 0
London
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Norwich

Funding & Sponsors
Primary sponsor type
Other
Name
Melanoma and Skin Cancer Trials Limited
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Peter MacCallum Cancer Centre, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Norfolk and Norwich University Hospitals NHS Foundation Trust
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with a primary invasive cutaneous melanomas \>=1mm thick to determine differences in the rate of local recurrence and melanoma specific survival. A reduction in margins is expected to improve quality of life in patients
Trial website
https://clinicaltrials.gov/study/NCT02385214
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marc Moncrieff
Address 0 0
Norfolk & Norwich University Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02385214