Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma (MelMarT-II)
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ClinicalTrials.gov Identifier: NCT03860883 |
Recruitment Status :
Recruiting
First Posted : March 4, 2019
Last Update Posted : April 1, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cutaneous Melanoma, Stage II | Procedure: Wide Local Excision = 1cm Margin Procedure: Wide Local Excision = 2cm Margin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 2998 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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) |
Actual Study Start Date : | December 17, 2019 |
Estimated Primary Completion Date : | December 31, 2029 |
Estimated Study Completion Date : | December 31, 2034 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm A (Wide Local Excision = 1cm Margin)
1cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction
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Procedure: 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. |
Active Comparator: Arm B (Wide Local Excision = 2cm Margin)
2 cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction
|
Procedure: 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. |
- Disease-Free Survival [ Time Frame: 0-60 months ]Time from randomisation to clinically, histologically or radiologically confirmed recurrence of melanoma
- Local Recurrence [ Time Frame: Day 0-Trial Completion (max. 120 months) ]Time from randomisation to any clinically, histologically or radiologically confirmed local recurrence of melanoma including satellite lesions and in transit metastases to regional draining lymph nodes
- Distant Disease-Free Survival [ Time Frame: Day 0-Trial Completion (max. 120 months) ]Time from randomisation to any clinically, histologically or radiologically confirmed distant recurrence of melanoma
- Melanoma-Specific Survival [ Time Frame: Day 0-Trial Completion (max. 120 months) ]Time from randomisation to death due to melanoma
- Overall Survival [ Time Frame: Day 0-Trial Completion (max. 120 months) ]Time from randomisation to death from any cause
- Melanoma-specific Quality of Life: FACT-M questionnaire [ Time Frame: Baseline, 3, 6, 12 & 24 months ]Measured by FACT-M (Functional Assessment of Cancer Therapy - Melanoma) questionnaire - It consists of two subsections: The FACT-G subsection is a 27-item compilation of general questions divided into four primary QOL domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. It is considered appropriate for use with patients with any form of cancer. The Melanoma Surgery Subscale evaluates melanoma-specific symptoms such as surgical morbidity and side effects.
- Neuropathic Pain: PainDetect questionnaire [ Time Frame: Baseline, 3, 6, 12 & 24 months ]Measured by PainDetect questionnaire
- Health-related Quality of Life: EQ-5D-5L questionnaire [ Time Frame: Baseline, 3, 6, 12 & 24 months ]Measured by EuroQoL EQ-5D-5L questionnaire - This tool contains 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
- Surgery Related Adverse Events [ Time Frame: Up to 30 days from surgery ]
The following surgical adverse events will be recorded from the time of surgery to 30 days following surgery (inclusive):
- wound dehiscence
- seroma/haematoma
- haemorrhage
- infection
- skin graft failure
- necrosis of flap used for reconstruction
- deep venous thrombosis
- urinary tract infection
- pneumonia
- cardiac complications
- lymphoedema
- Adverse Events [ Time Frame: Within 1 year from randomisation ]An Adverse Event (AE) is any untoward medical occurrence in a participant administered a treatment which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavourable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the treatment timing, whether or not considered related to the treatment. An AE is any adverse change (developing or worsening) from the participant's pre-treatment condition, including intercurrent illness.
- Health Economic Evaluation [ Time Frame: Baseline, 3, 6, 12 & 24 months ]Data collected for economic analysis will be from hospital notes, MBS and PBS data (Australia) and patient reported outcome measures (including an employment questionnaire) at baseline, 3, 6, 12 and 24 months and at melanoma recurrence.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must have an invasive primary cutaneous melanoma with Breslow thickness > 2mm, or 1-2mm with ulceration (pT2b-pT4b, AJCC 8th edition) as determined by diagnostic biopsy (narrow excision, incision or punch biopsy) and subsequent histopathological analysis.
- Must have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm, or sole).
- An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary melanoma.
- Randomisation and the primary study intervention, including staging sentinel node biopsy, must be completed within 120 days of the original diagnosis.
- Patients must be 18 years or older at time of consent.
- Patient must be able to give informed consent and comply with the treatment protocol and follow-up plan.
- Life expectancy of at least 5 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI.
- Patients must have an ECOG performance score between 0 and 1.
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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.
Exclusion Criteria:
- Uncertain diagnosis of melanoma i.e. so-called 'melanocytic lesion of unknown malignant potential'.
- Patient has already undergone wide local excision at the site of the primary index lesion.
- Patient unable or ineligible to undergo staging sentinel lymph node biopsy of the primary index lesion.
- Desmoplastic or neurotropic melanoma.
- Microsatellitosis as per AJCC 8th edition definition
- Subungual melanoma
- 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.
- History of previous or concurrent (i.e., second primary) invasive melanoma.
- Melanoma located distal to the metacarpophalangeal joint, on the tip of the nose, the eyelids or on the ear, mucous membranes or internal viscera.
- Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma.
- 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.
- 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.
- Melanoma-related operative procedures not corresponding to criteria described in the protocol.
- 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.
- History of organ transplantation.
- Oral or parenteral immunosuppressive agents (not topical or inhaled steroids) at any time during study participation or within 6 months prior to enrolment.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860883
Contact: Melanoma and Skin Cancer Trials Coordinator | +61 3 9903 9022 | melmart@masc.org.au |

Study Chair: | Michael Henderson | Peter MacCallum Cancer Centre, Australia | |
Study Chair: | Marc Moncrieff | Norfolk & Norwich University Hospital |
Responsible Party: | Melanoma and Skin Cancer Trials Limited |
ClinicalTrials.gov Identifier: | NCT03860883 |
Other Study ID Numbers: |
02.18 |
First Posted: | March 4, 2019 Key Record Dates |
Last Update Posted: | April 1, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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