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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03860883




Registration number
NCT03860883
Ethics application status
Date submitted
7/02/2019
Date registered
4/03/2019

Titles & IDs
Public title
Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma
Scientific title
Melanoma Margins Trial-II - A Phase III, Multi-centre Randomised Controlled Trial Investigating 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma (02.18 MelMarT-II)
Secondary ID [1] 0 0
02.18
Universal Trial Number (UTN)
Trial acronym
MelMarT-II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous Melanoma, Stage II 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) - 1cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction

Active comparator: Arm B (Wide Local Excision = 2cm Margin) - 2 cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction


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

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

Outcomes
Primary outcome [1] 0 0
Disease-Free Survival
Timepoint [1] 0 0
0-60 months
Secondary outcome [1] 0 0
Local Recurrence
Timepoint [1] 0 0
Day 0-Trial Completion (max. 120 months)
Secondary outcome [2] 0 0
Distant Disease-Free Survival
Timepoint [2] 0 0
Day 0-Trial Completion (max. 120 months)
Secondary outcome [3] 0 0
Melanoma-Specific Survival
Timepoint [3] 0 0
Day 0-Trial Completion (max. 120 months)
Secondary outcome [4] 0 0
Overall Survival
Timepoint [4] 0 0
Day 0-Trial Completion (max. 120 months)
Secondary outcome [5] 0 0
Melanoma-specific Quality of Life: FACT-M questionnaire
Timepoint [5] 0 0
Baseline, 3, 6, 12 & 24 months
Secondary outcome [6] 0 0
Neuropathic Pain: PainDetect questionnaire
Timepoint [6] 0 0
Baseline, 3, 6, 12 & 24 months
Secondary outcome [7] 0 0
Health-related Quality of Life: EQ-5D-5L questionnaire
Timepoint [7] 0 0
Baseline, 3, 6, 12 & 24 months
Secondary outcome [8] 0 0
Surgery Related Adverse Events
Timepoint [8] 0 0
Up to 12-months from the date of surgery
Secondary outcome [9] 0 0
Health Economic Evaluation
Timepoint [9] 0 0
Baseline, 3, 6, 12 & 24 months
Secondary outcome [10] 0 0
Serious Adverse Events
Timepoint [10] 0 0
from randomisation up to 12-months post-surgery

Eligibility
Key inclusion criteria
Patients may be included in the study if they meet ALL of the following criteria:

1. 1. Patients must have a Stage II primary invasive cutaneous melanoma (pT2b-pT4b, AJCC 8th edition) with Breslow thickness >1.0mm to 2.0mm; >2.0mm to 4.0mm or >4.0mm with ulceration, or >2.0mm to 4.0mm; or >4.0mm without ulceration (Table 1) as determined by diagnostic biopsy (narrow excision, incision, shave or punch biopsy) and subsequent histopathological analysis.
2. Must have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm or sole).
3. An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary melanoma.
4. 4. Surgical intervention (which refers to the staging -SLNB and WLE as these are both to be done on the same day) must be completed within 120 days of the original diagnosis. Surgical intervention must also be performed within 28 days of randomisation.
5. Patients must be 18 years or older at time of consent.
6. Patient must be able to give informed consent and comply with the treatment protocol and follow up plan.
7. Life expectancy of at least 5 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI.
8. Patients must have an ECOG performance score between 0 and 1 at screening.
9. 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 (with the exception of successfully treated uterine/cervical or non-melanoma skin cancers (SCCs/BCCs) 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
Patients will be excluded from the study for ANY of the following reasons:

1. Uncertain diagnosis of melanoma i.e., so-called 'melanocytic lesion of unknown malignant potential'.
2. Patient has already undergone WLE at the site of the primary index lesion.
3. Patient unable or ineligible to undergo staging SLNB of the primary index lesion.
4. Perineural invasion or neurotropic melanoma: Neurotropism or perineural invasion in any type of melanoma is an exclusion. Perineural invasion does not include entrapment of nerves within the main primary tumour mass.
5. Desmoplastic melanoma: with any patient where pathology determines melanoma as PURE desmoplastic (as per WHO definition of >90% desmoplasia), they are not eligible for this study. However melanomas with less than 90% desmoplasia or mixed desmoplastic subtypes are eligible unless there is neurotropism present (perineural invasion).
6. Microsatellitosis (a nest of metastatic tumour cells found to be growing away from the primary tumour) as per AJCC 8th edition definition is an exclusion.
7. Subungual melanoma
8. 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.
9. History of previous or concurrent (i.e. >1 primary melanoma) invasive melanoma.
10. Melanoma located distal to the metacarpophalangeal joint; on the tip of the nose; the eyelids or on the ear; genitalia, perineum or anus; mucous membranes or internal viscera.
11. Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma.
12. Patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, including -SLNB, of the index melanoma.
13. Any additional solid tumour or hematologic malignancy during the past 5 years (with exception of non- melanoma skin cancers (T1 skin lesions of squamous cell carcinoma (SCCs), basal cell carcinoma (BCCs)), or uterine/cervical cancer).
14. Melanoma-related operative procedures not corresponding to criteria described in the protocol.
15. 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.
16. History of organ transplantation.
17. Oral or parenteral immunosuppressive agents (not topical or inhaled steroids) at enrolment or within 6 months prior to enrolment.

Pregnancy is not a specific exclusion criterion for this trial, though it may not be clinically appropriate to perform a wide excision and SLNB until the pregnancy has been completed, which may exclude the patient due to violation of inclusion criterion 4. We would advise careful counselling of the patient prior to enrolling the patient, which would include a discussion at the treating centre's multidisciplinary team meeting or tumour board. We would strongly advise contacting the central trial office to discuss the case prior to enrolling on the study.

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
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2034
Actual
Sample size
Target
2998
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Calvary Public Hospital Bruce - Bruce
Recruitment hospital [2] 0 0
The Canberra Hospital - Garran
Recruitment hospital [3] 0 0
Westmead Hospital - Sydney
Recruitment hospital [4] 0 0
Melanoma Institute Australia - Sydney
Recruitment hospital [5] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [7] 0 0
Robina Hospital - Gold Coast
Recruitment hospital [8] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [9] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [10] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
2605 - Garran
Recruitment postcode(s) [3] 0 0
2145 - Sydney
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment postcode(s) [5] 0 0
4102 - Brisbane
Recruitment postcode(s) [6] 0 0
4226 - Gold Coast
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
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District of Columbia
Country [7] 0 0
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State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
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Indiana
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Kansas
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United States of America
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Kentucky
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Maryland
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Michigan
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Missouri
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Nebraska
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New Jersey
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New Mexico
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Texas
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Utah
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Vermont
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Virginia
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Wisconsin
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Ontario
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Quebec
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Ireland
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Cork
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Padova
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Pavia
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Italy
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Torino
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Noord-Brabant
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Groningen
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Heerlen
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Maastricht
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Utrecht
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Veldhoven
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Zwolle
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New Zealand
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Auckland
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Slovenia
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Ljubljana
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Sweden
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Gothenburg
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Sweden
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Kristianstad
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United Kingdom
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Birmingham
Country [57] 0 0
United Kingdom
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Cornwall
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United Kingdom
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East Yorkshire
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Essex
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Lancashire
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United Kingdom
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Oxford
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The Bays
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West Sussex
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Bristol
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Cambridge
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Leeds
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Liverpool
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London,
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London
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Manchester
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Middlesbrough
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Norwich
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United Kingdom
State/province [73] 0 0
Nottingham

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
Norfolk and Norwich University Hospitals NHS Foundation Trust
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Canadian Cancer Trials Group
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Cancer Trials Ireland
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Zuyderland Medical Centre
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Henderson
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Melanoma and Skin Cancer Trials Coordinator
Address 0 0
Country 0 0
Phone 0 0
+61 3 9903 9022
Fax 0 0
Email 0 0
melmart@masc.org.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03860883