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Melanoma Margins Trial (MelMarT): A Phase III, multi-centre, multi-national randomised control trial investigating 1cm v 2cm wide excision margins for primary cutaneous melanoma
Study on Excision Margins for Primary Skin-Related Melanoma
K
Karl Bilimoria
Primary Investigator
Not Recruiting
18 years - 100 years
All
Phase
3
1 Location
Brief description of study
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 stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
This study will determine whether there is a difference in disease-free survival rates for patients with primary cutaneous melanoma with Breslow thickness > 2mm or 1-2mm with ulceration (pT2b-pT4b, AJCC 8th edition), treated with either a 1cm excision margin or 2cm margin. The study is designed to be able to provedisprove that there is no difference in risk of the tumour recurringund the scar or anywhere else in the body between the two groups of patients. If the study shows no risk of tumour recurrence then we will also be able to determine how much of an impact the narrower excision has on patients in terms of improved quality of life and reduced side effects from the surgery and melanoma disease. This trial will also evaluate and determine the economic impact of narrower excision margins on the health services and society in general.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Cutaneious melanoma, Cancer
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria:
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.
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.
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.
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.
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: 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
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; genitalia, perineum or anus; 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 enrolment or within 6 months prior to enrolment.
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.
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.
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.
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.
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: 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
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; genitalia, perineum or anus; 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 enrolment or within 6 months prior to enrolment.
Updated on
04 Aug 2025.
Study ID: CTO-S2015, 23691
This study investigates the effects of different excision margins on disease-free survival in patients with primary cutaneous melanoma. The purpose of this study is to compare a 1 cm margin to a 2 cm margin in patients with stage II primary invasive cutaneous melanomas. Melanoma is a type of skin cancer that can be aggressive, and treatment often involves removing the tumor with some surrounding tissue. This study aims to see if smaller margins are as effective as larger ones in preventing the cancer from returning.
Participants in the study will be randomly assigned to have either a 1 cm or 2 cm margin removed around their melanoma. This trial will evaluate whether there are differences in the recurrence of the tumor between the two study arms. Additionally, the study will assess the impact of the excision margin size on quality of life and side effects. The study will also look at the economic impact of using narrower excision margins on healthcare services.
- Who can participate: Adults aged 18 and older with stage II primary invasive cutaneous melanoma are eligible to participate. Key eligibility factors include having a melanoma with a Breslow thickness greater than 2mm without ulceration or greater than 1mm with ulceration, and being able to undergo the required surgical procedures within 120 days of diagnosis.
- Study details: Participants will undergo surgery to remove the melanoma with either a 1 cm or 2 cm margin. The study will compare the outcomes of these two approaches. An inactive substance that looks like the investigational medicine/vaccine but does not contain any medicine is not applicable in this trial.
