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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 90 days from the date of surgery
Secondary outcome [9] 0 0
Adverse Events
Timepoint [9] 0 0
Within 1 year from randomisation
Secondary outcome [10] 0 0
Health Economic Evaluation
Timepoint [10] 0 0
Baseline, 3, 6, 12 & 24 months

Eligibility
Key inclusion criteria
1. Patients must have a stage II primary invasive cutaneous melanoma with Breslow thickness >2mm without ulceration), or >1mm (with ulceration only) (pT2b-pT4b, AJCC 8th edition) as determined by diagnostic biopsy (narrow excision, incision 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. Surgery (which refers to the staging sentinel node biopsy and wide local excision as these are both to be done on the same day) must be completed within 120 days of the original diagnosis.
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.
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 (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
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 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: 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 other desmoplasia or mixed subtypes are eligible unless there is neurotropism present (peri-neural invasion).Peri-neural invasion does not include entrapment of nerves within the main primary tumour mass. Microsatellitosis as per AJCC 8th edition definition
5. Subungual melanoma
6. 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.
7. History of previous or concurrent (i.e., second primary) invasive melanoma.
8. 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.
9. Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma.
10. 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.
11. 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.
12. Melanoma-related operative procedures not corresponding to criteria described in the protocol.
13. 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.
14. History of organ transplantation.
15. 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 sentinel node biopsy until the pregnancy has been completed, which is likely to 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
Phase 3
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
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United States of America
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Arizona
Country [3] 0 0
United States of America
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Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
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Connecticut
Country [6] 0 0
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District of Columbia
Country [7] 0 0
United States of America
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
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Illinois
Country [10] 0 0
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Kansas
Country [11] 0 0
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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 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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Oregon
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Pennsylvania
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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
Country [30] 0 0
Canada
State/province [30] 0 0
Alberta
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Canada
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British Columbia
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Canada
State/province [32] 0 0
Manitoba
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Canada
State/province [33] 0 0
Ontario
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Canada
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Quebec
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Italy
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Padova
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Italy
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Pavia
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Italy
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Torino
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Netherlands
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Flevoland
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Netherlands
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Gelderland
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Netherlands
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Groningen
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Netherlands
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Heerlen
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Netherlands
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Maastricht
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New Zealand
State/province [43] 0 0
Auckland
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Sweden
State/province [44] 0 0
Gothenburg
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Sweden
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Kristianstad
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Birmingham
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Cornwall
Country [48] 0 0
United Kingdom
State/province [48] 0 0
East Yorkshire
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Essex
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Oxford
Country [51] 0 0
United Kingdom
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The Bays
Country [52] 0 0
United Kingdom
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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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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Middlesbrough
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United Kingdom
State/province [61] 0 0
Norwich
Country [62] 0 0
United Kingdom
State/province [62] 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
[email protected]
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