Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma (MelMarT-II)
Cutaneous Melanoma, Stage II
About this trial
This is an interventional treatment trial for Cutaneous Melanoma, Stage II focused on measuring Malignant, Melanoma, Cancer, Surgery
Eligibility Criteria
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:
Patients will be excluded from the study for ANY of the following reasons:
- 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.
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.
Sites / Locations
- University of South Alabama Mitchell Cancer InstituteRecruiting
- Banner MD Anderson Cancer CenterRecruiting
- Mayo Clinic PhoenixRecruiting
- University of Arkansas for Medical SciencesRecruiting
- The Angeles (Cedars-Sinai Medical Center and its Affiliates)Recruiting
- UC Irvine Health - Chao Family Comprehensive Cancer CenterRecruiting
- Stanford Cancer InstituteRecruiting
- Kaiser Permanente - Vallejo Medical CenterRecruiting
- Kaiser Permanente - Walnut Creek Medical CenterRecruiting
- Smilow Hospital Care Center, GuilfordRecruiting
- Yale UniversityRecruiting
- MedStar Georgetown University HospitalRecruiting
- MedStar Washington Hospital CenterRecruiting
- Baptist MD Anderson Cancer CenterRecruiting
- Mayo Clinic in FloridaRecruiting
- Lakeland Regional Health Hollis Cancer CenterRecruiting
- Moffitt Cancer Center - McKinley CampusRecruiting
- Moffitt Cancer Center, Magnolia CampusRecruiting
- Emory University Hospital MidtownRecruiting
- Emory UniversityRecruiting
- Emory Saint Joseph's HospitalRecruiting
- Northside Hospital AtlantaRecruiting
- Northside Hospital Cancer Institute
- Nancy N and JC Lewis Cancer & Research Pavilion St. Joseph's/CandlerRecruiting
- Northwestern Medicine Cancer Center KishwaukeeRecruiting
- Northwestern UniversityRecruiting
- Northwestern Medicine Cancer Center DelnorRecruiting
- Northwestern Medicine Cancer Center Lake Forest HospitalRecruiting
- Advocate Lutheran General HospitalRecruiting
- Northwestern Medicine Cancer Center WarrenvilleRecruiting
- University of Kansas Hospital - Indian Creek CampusRecruiting
- University of Kansas Hospital- Westwood Cancer CenterRecruiting
- University of KentuckyRecruiting
- MedStar Franklin Square Medical CenterRecruiting
- Mercy Health Saint Mary'sRecruiting
- Spectrum Health at Butterworth CampusRecruiting
- West Michigan Cancer CentreRecruiting
- Siteman Cancer Centre, Barnes Jewish West CountyRecruiting
- University of Kansas Cancer CenterRecruiting
- Cox South HospitalRecruiting
- Nebraska Medicine - BellevueRecruiting
- Nebraska Medicine-Village PointeRecruiting
- University of Nebraska MedicineRecruiting
- Cooperman Barnabas Medical CenterRecruiting
- Rutgers Cancer Institute of New JerseyRecruiting
- Northwell Health Imbert Cancer CenterRecruiting
- Roswell Park Cancer InstituteRecruiting
- Northwell Health/Center for Advanced MedicineRecruiting
- NYU Langone Medical Center (Winthrop Hospital)Recruiting
- Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Vassar Brothers Medical CenterRecruiting
- University of RochesterRecruiting
- State University of New York Upstate Medical UniversityRecruiting
- State University of New York Upstate Medical Center-Community CampusRecruiting
- Wilmont Cancer Institute at WebsterRecruiting
- University of North Carolina at Chapel HillRecruiting
- Duke University Medical CenterRecruiting
- East Carolina UniversityRecruiting
- Sanford Broadway Medical CentreRecruiting
- Sanford Roger Maris Cancer CentreRecruiting
- University Hospitals Avon Health CenterRecruiting
- Miami Valley Hospital SouthRecruiting
- University Hospitals Geauga Medical CenterRecruiting
- University of CincinnatiRecruiting
- University Hospitals Cleveland Medical CentreRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- University Hospitals Chagrin Highlands Medical CentreRecruiting
- West Chester Hospital (OH394)Recruiting
- University Hospitals St. John Medical CenterRecruiting
- OUHSC Stephenson Cancer CenterRecruiting
- Mercy Health Center - Oncology HematologyRecruiting
- Kaiser Sunnyside Medical CenterRecruiting
- Kaiser Permanente Northwest - Oncology ClinicRecruiting
- St. Luke's University Health Network - Allentown Cancer CenterRecruiting
- St Luke's University Health Network, Bethlehem CampusRecruiting
- St Luke's University Health Network, Anderson CampusRecruiting
- Fox Chase Cancer CenterRecruiting
- St Luke's University Health Network Quakertown CampusRecruiting
- St. Luke's University Health Network - Upper BucksRecruiting
- Guthrie Medical Group PC-Robert Packer HospitalRecruiting
- Medical University of South CarolinaRecruiting
- The University of Texas MD Anderson Cancer CenterRecruiting
- Univ of Texas Health Science Center at San AntonioRecruiting
- Intermountain Medical CenterRecruiting
- Huntsman Cancer Institute (The University of Utah)Recruiting
- University of Vermont Medical CenterRecruiting
- University of Vermount and Sate Agricultural CollegeRecruiting
- University of Virginia Health SystemRecruiting
- VCU Massey Cancer Center Peninsula Cancer InstituteRecruiting
- VCU Massey Cancer CenterRecruiting
- Carilion Roanoke Memorial HospitalRecruiting
- VCU Massey Cancer Center Affiliate Valley HealthRecruiting
- University of Wisconsin Carbone Cancer CenterRecruiting
- Marshfield Medical Center - MarshfieldRecruiting
- Aurora St Luke's Medical CenterRecruiting
- Medical College of WisconsinRecruiting
- Calvary Public Hospital BruceRecruiting
- The Canberra Hospital
- Westmead HospitalRecruiting
- Melanoma Institute AustraliaRecruiting
- Royal Prince Alfred HospitalRecruiting
- Princess Alexandra Hospital
- Robina Hospital
- Royal Adelaide HospitalRecruiting
- Peter MacCallum Cancer CentreRecruiting
- The Alfred HospitalRecruiting
- Tom Baker Cancer CentreRecruiting
- BCCA - Cancer Centre for the Southern InteriorRecruiting
- CancerCare Manitoba
- Royal Victoria Regional Health CentreRecruiting
- Hamilton Health Sciences CentreRecruiting
- Ottawa Hospital Research InstituteRecruiting
- Sunnybrook Health Sciences CentreRecruiting
- UHN - Princess Margaret Cancer CentreRecruiting
- Hopital Maisonneuve-RosemontRecruiting
- Hotel-Dieu de QuebecRecruiting
- IOV Istituto Oncologico Veneto IRCCS-Padova
- Fondazione IRCCS Policlinico San Matteo
- AOU Città della Salute e della Scienza di Torino
- Flevo HospitalRecruiting
- Ziekenhuis Gelderse ValleiRecruiting
- Gelre HospitalRecruiting
- University Medical Centre GroningenRecruiting
- Zuyderland Medical CenterRecruiting
- Maastricht University Medical CenterRecruiting
- North Shore HospitalRecruiting
- Sahlgrenska University HospitalRecruiting
- Central Hospital KristianstadRecruiting
- University Hospitals Birmingham NHS Foundation TrustRecruiting
- Royal Cornwall Hospital NHS TrustRecruiting
- Hull University Teaching Hospitals NHS TrustRecruiting
- MID & South Essex NHS Foundation TrustRecruiting
- Oxford University Hospitals NHS Foundation TrustRecruiting
- Imperial College Healthcare NHS TrustRecruiting
- Queen Victoria Hospital NHS Foundation TrustRecruiting
- North Bristol NHS TrustRecruiting
- Cambridge University Hospitals NHS Foundation TrustRecruiting
- The Leeds Teaching Hospitals NHS TrustRecruiting
- St. Helens & Knowsley Teaching Hospitals NHS TrustRecruiting
- The Royal Marsden Hospital NHS Foundation TrustRecruiting
- Royal Free London NHS Foundation TrustRecruiting
- Guy's and St Thomas's NHS Foundation Trust, of St Thomas' HospitalRecruiting
- St George's University Hospitals NHS Foundation TrustRecruiting
- The Christie NHS Foundation TrustRecruiting
- South Tees Hospitals NHS Foundation Trust of The James Cook University HospitalRecruiting
- Norfolk and Norwich University Hospital NHS TrustRecruiting
- Nottingham University Hospitals, NHS Trust, Trust HQ, City HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm A (Wide Local Excision = 1cm Margin)
Arm B (Wide Local Excision = 2cm Margin)
1cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction
2 cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction