Surgical Excision Margins for Melanoma (MelMarT-II Trial)
Recruiting in Palo Alto (17 mi)
+190 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Melanoma and Skin Cancer Trials Limited
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are taking oral or injected immunosuppressive agents, you may not be eligible to participate.
What data supports the effectiveness of the treatment Wide Local Excision for melanoma?
Wide local excision (WLE) is the standard treatment for localized primary cutaneous melanomas, and it is generally effective in reducing the risk of local recurrence when appropriate margins are achieved.
12345Is wide local excision (WLE) generally safe for humans?
The research does not provide specific safety data for wide local excision (WLE) in humans, but it is a standard surgical procedure used for treating melanoma, suggesting it is generally considered safe.
34567How does the surgical excision margin treatment for melanoma differ from other treatments?
This treatment involves surgically removing melanoma with either a 1 cm or 2 cm margin around the tumor, which is less extensive than the historically recommended 3 to 5 cm margins. Studies suggest that these narrower margins do not increase the risk of cancer returning or affect survival rates, making it a more conservative and potentially less invasive option.
248910Eligibility Criteria
Adults over 18 with stage II primary invasive cutaneous melanoma, as defined by specific criteria, who can undergo surgery within 120 days of diagnosis. They should have a life expectancy of at least five years and be able to consent and follow the trial protocol. Those with certain types of melanoma or past cancers (except some successfully treated ones) are excluded.Inclusion Criteria
My skin cancer is at an early stage but deep or ulcerated.
I can carry out all my usual activities without help.
I am 18 years old or older.
I had surgery for my condition within 4 months of being diagnosed.
A 2cm clear area can be safely removed around my melanoma or biopsy scar.
My melanoma is on the skin, including sensitive areas like the scalp or sole.
A 2cm clear area can be safely removed around my melanoma or biopsy scar.
Exclusion Criteria
I am scheduled for radiation therapy at the melanoma site after surgery.
I cannot have or am not eligible for a specific lymph node biopsy.
I had surgery to remove lymph nodes affected by melanoma.
My melanoma has spread beyond the original site.
I have had an organ transplant.
I haven't had any other cancer types in the last 5 years, except for certain exceptions.
My melanoma is classified as desmoplastic or neurotropic.
My melanoma is in a specific part of my body.
I have melanoma under my nail.
I haven't taken immunosuppressive drugs in the last 6 months.
I have had surgery to remove a large area around my primary cancer site.
Participant Groups
This study compares two surgical techniques for removing skin cancer: one uses a wider (2cm) and the other a narrower (1cm) margin around the tumor. The goal is to see if smaller margins are just as effective while improving quality of life.
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (Wide Local Excision = 1cm Margin)Experimental Treatment1 Intervention
1cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction
Group II: Arm B (Wide Local Excision = 2cm Margin)Active Control1 Intervention
2 cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction
Wide Local Excision = 1cm Margin is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Wide Local Excision for:
- Primary invasive cutaneous melanoma
🇺🇸 Approved in United States as Wide Local Excision for:
- Primary invasive cutaneous melanoma
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of Virginia Health SystemCharlottesville, VA
Marshfield Medical Center - MarshfieldMarshfield, WI
St Luke's University Health Network, Anderson CampusEaston, PA
Ohio State University Comprehensive Cancer CenterColumbus, OH
More Trial Locations
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Who is running the clinical trial?
Melanoma and Skin Cancer Trials LimitedLead Sponsor
Zuyderland Medical CentreCollaborator
Norfolk and Norwich University Hospitals NHS Foundation TrustCollaborator
Canadian Cancer Trials GroupCollaborator
Cancer Trials IrelandCollaborator
References
Frequency of residual melanoma in wide local excision (WLE) specimens after complete excisional biopsy. [2015]We sought to better understand the role of wide local excision (WLE) in the treatment of cutaneous melanoma by analyzing residual or locally metastatic disease in WLE specimens of melanomas initially diagnosed with a complete excisional biopsy.
Correlation Between Surgical and Histologic Margins in Melanoma Wide Excision Specimens. [2019]Wide surgical excision is the standard treatment for localized primary cutaneous melanomas, with a narrow histologic margin associated with an increased risk of local recurrence. The correlation between surgical and histologic margins is poorly documented in the literature.
Risk factors for positive or equivocal margins after wide local excision of 1345 cutaneous melanomas. [2017]Positive or equivocal margins after wide local excision (WLE) complicate surgical management of cutaneous melanoma.
Risk Factors Predicting Positive Margins at Primary Wide Local Excision of Cutaneous Melanoma. [2017]A small percentage of patients will have positive histological margins after primary wide local excision (WLE) of cutaneous melanoma (CM). Risk factors that predict marginal involvement at WLE remain unclear.
The end of wide local excision (WLE) margins for melanoma ? [2023]Is there nowadays any benefit of continuing the practice of routine wide local excision (WLE) for primary stage I/II cutaneous melanoma?
Recurrence Rates Over 20 Years in the Treatment of Malignant Melanoma: Immediate Versus Delayed Reconstruction. [2020]Wide local excision (WLE) with a safety margin is the standard of treatment for primary head and neck cutaneous malignant melanoma (HNCMM). Studies have demonstrated inconsistency in recurrence rates following immediate versus delayed reconstruction. The objectives of this study were to assess and compare recurrence rates after WLE of HNCMM followed by immediate or delayed reconstruction in determining recurrence-free survival estimates.
Reducing margins of wide local excision in head and neck melanoma for function and cosmesis: 5-year local recurrence-free survival. [2015]The proximity of head and neck (H&N) melanomas to critical anatomical structures requires that surgeons achieve a balance between adequate margins of excision and the functional and cosmetic needs of patients. This study sought to determine the risk associated with reducing margins of wide local excision (WLE) in H&N melanoma and to identify risk factors of recurrence.
Wide Excisional Surgery in Invasive Melanoma Treatment: Factors Driving Non-compliance With National Guidelines. [2020]Margin size during wide excisional surgery for invasive melanoma treatment have been established by national guidelines. This study identified factors associated with wider than recommended excisional margins and its impact on survival.
Recommended width of excision for primary malignant melanoma. [2019]Wide local excision for melanoma with margins of 3 to 5 cm have been advocated in the literature for nearly 140 years. These reports have grouped all stages of melanoma rather than addressing primary early stage disease. Breslow first advocated limited excision margins for these tumors. We have been excising all thicknesses of melanoma with a limited margin (1.00-1.50 cm, mostly 1.00 cm) since 1975. We advocate a 1 cm excision margin irrespective of tumor thickness. Clark has shown that melanoma invades in a vertical fashion, and thus one would expect to be more generous in depth than in width on a pathologic basis. Two studies have shown that there is no difference in the increase in locoregional recurrence and no change in death rate from the disease with more conservative treatment margins. Excision of this lesion is not an office procedure. It should be performed meticulously in an operating room, preferably under light general anesthesia.
2-cm versus 4-cm surgical excision margins for primary cutaneous melanoma thicker than 2 mm: a randomised, multicentre trial. [2015]Optimum surgical resection margins for patients with clinical stage IIA-C cutaneous melanoma thicker than 2 mm are controversial. The aim of the study was to test whether survival was different for a wide local excision margin of 2 cm compared with a 4-cm excision margin.