2998 Participants Needed

Surgical Excision Margins for Melanoma

(MelMarT-II Trial)

Recruiting at 190 trial locations
Ma
Overseen ByMelanoma and Skin Cancer Trials Coordinator
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Is 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.12345

How 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.26789

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.123610

Who Is on the Research Team?

MH

Michael Henderson

Principal Investigator

Peter MacCallum Cancer Centre, Australia

MM

Marc Moncrieff

Principal Investigator

Norfolk & Norwich University Hospital

Are You a Good Fit for This Trial?

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 had surgery for my condition within 4 months of being diagnosed.
See 6 more

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.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Intervention

Participants undergo wide local excision with either a 1cm or 2cm margin, including sentinel lymph node biopsy and possible reconstruction

1 day
1 visit (in-person)

Post-Surgery Follow-up

Participants are monitored for serious adverse events and surgery-related adverse events

12 months
Multiple visits (in-person and virtual)

Long-term Follow-up

Participants are monitored for disease-free survival, local recurrence, distant disease-free survival, and overall survival

Up to 120 months

What Are the Treatments Tested in This Trial?

Interventions

  • Wide Local Excision = 1cm Margin
  • Wide Local Excision = 2cm Margin
Trial Overview 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.
How Is the Trial Designed?
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

Who Is Running the Clinical Trial?

Melanoma and Skin Cancer Trials Limited

Lead Sponsor

Trials
18
Recruited
6,500+

Zuyderland Medical Centre

Collaborator

Trials
26
Recruited
107,000+

Norfolk and Norwich University Hospitals NHS Foundation Trust

Collaborator

Trials
57
Recruited
29,800+

Canadian Cancer Trials Group

Collaborator

Trials
135
Recruited
70,300+

Cancer Trials Ireland

Collaborator

Trials
85
Recruited
25,600+

Published Research Related to This Trial

In a study of 807 wide local excisions (WLE) of melanomas initially diagnosed with complete excisional biopsy, residual melanoma was found in 34 cases (4.2%), indicating that residual disease can occur even after what is thought to be complete removal.
The lentigo maligna subtype of melanoma was identified as having a higher risk of residual disease in WLE specimens, suggesting that while WLE is effective for controlling primary tumors, it may not fully prevent local metastatic recurrence.
Frequency of residual melanoma in wide local excision (WLE) specimens after complete excisional biopsy.Bolshinsky, V., Lin, MJ., Serpell, J., et al.[2015]
In a study of 252 melanoma specimens, it was found that formalin-fixed specimens consistently shrank by about 14%, suggesting a need for a 15% correction factor when evaluating surgical margins after fixation.
The measured surgical margins taken during excision were not reliable predictors of the histologic margins, indicating that surgeons may need to reconsider how they assess and plan for excision margins in melanoma treatment.
Correlation Between Surgical and Histologic Margins in Melanoma Wide Excision Specimens.Friedman, EB., Dodds, TJ., Lo, S., et al.[2019]
In a study of 1345 melanoma cases treated with wide local excision (WLE), 4.2% had positive or equivocal margins, with risk factors including noncompliance with surgical margins and specific anatomic locations like the head and neck.
Key risk factors for positive margins included noncompliance with recommended margins (5.57 times more likely), location on sensitive areas (5.07 times more likely), and increasing age, highlighting the importance of adhering to surgical guidelines.
Risk factors for positive or equivocal margins after wide local excision of 1345 cutaneous melanomas.Miller, CJ., Shin, TM., Sobanko, JF., et al.[2017]

Citations

Frequency of residual melanoma in wide local excision (WLE) specimens after complete excisional biopsy. [2015]
Correlation Between Surgical and Histologic Margins in Melanoma Wide Excision Specimens. [2019]
Risk factors for positive or equivocal margins after wide local excision of 1345 cutaneous melanomas. [2017]
Risk Factors Predicting Positive Margins at Primary Wide Local Excision of Cutaneous Melanoma. [2017]
The end of wide local excision (WLE) margins for melanoma ? [2023]
Recurrence Rates Over 20 Years in the Treatment of Malignant Melanoma: Immediate Versus Delayed Reconstruction. [2020]
Reducing margins of wide local excision in head and neck melanoma for function and cosmesis: 5-year local recurrence-free survival. [2015]
Wide Excisional Surgery in Invasive Melanoma Treatment: Factors Driving Non-compliance With National Guidelines. [2020]
Recommended width of excision for primary malignant melanoma. [2019]
2-cm versus 4-cm surgical excision margins for primary cutaneous melanoma thicker than 2 mm: a randomised, multicentre trial. [2015]
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