400 Participants Needed

Excision Margins for Melanoma

(MelMarT Trial)

Recruiting at 19 trial locations
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 a primary invasive cutaneous melanomas \>=1mm thick to determine differences in the rate of local recurrence and melanoma specific survival. A reduction in margins is expected to improve quality of life in patients

Will I have to stop taking my current medications?

The trial requires that participants do not take oral or injected immunosuppressive medications during the study or within 6 months before joining. If you are on such medications, you may need to stop them to participate.

Is wide local excision (WLE) generally safe for humans?

Wide local excision (WLE) is a common surgical procedure used to treat melanoma, and it is generally considered safe for humans. The studies focus on the effectiveness and recurrence rates of WLE, but they do not report significant safety concerns.12345

How does the treatment of wide local excision with 1cm or 2cm margins for melanoma differ from other treatments?

Wide local excision with 1cm or 2cm margins is a surgical treatment for melanoma that focuses on removing the tumor with a specific margin of healthy tissue around it. This approach is unique because it uses smaller margins compared to traditional methods, which often recommend wider margins of 3 to 5 cm, and it is performed meticulously in an operating room, often under light general anesthesia.36789

What data supports the effectiveness of the treatment Wide Local Excision for melanoma?

Wide Local Excision (WLE) is a common treatment for melanoma, aiming to remove cancerous tissue with a margin of healthy skin to reduce the risk of cancer returning. Although the research does not directly address effectiveness, it suggests that WLE is a standard practice, indicating its general acceptance and use in managing localized melanoma.123610

Who Is on the Research Team?

MM

Marc Moncrieff

Principal Investigator

Norfolk & Norwich University Hospital

MH

Prof Michael Henderson

Principal Investigator

Peter MacCallum Cancer Center

Are You a Good Fit for This Trial?

Adults over 18 with a life expectancy of at least 10 years and an ECOG score of 0-1, who have had a primary cutaneous melanoma thicker than 1mm completely excised. They must be able to follow the trial protocol and have no history of organ transplants, immunosuppressive treatments in the past six months, or other cancers within five years (with some exceptions).

Inclusion Criteria

My main cancer treatment and tests were done within 4 months of diagnosis.
Patient must be able to give informed consent and comply with the treatment protocol and follow-up plan
My life expectancy is over 10 years, not counting my melanoma.
See 6 more

Exclusion Criteria

My skin condition is possibly cancerous but not confirmed.
The presence of microsatellite instability as defined by the AJCC 2009 guidelines.
My melanoma is located on specific areas like fingertips, nose tip, eyelids, ears, or internal organs.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

Up to 30 days
1 visit (in-person)

Follow-up

Participants are monitored for local melanoma recurrence, adverse events, and quality of life assessments

120 months
Regular visits at Baseline, 3, 6, 12, 24, and 60 months

Long-term Follow-up

Participants are monitored for overall survival and recurrence-free survival

120 months

What Are the Treatments Tested in This Trial?

Interventions

  • Wide Local Excision = 1cm Margin
  • Wide Local Excision = 2cm Margin
Trial Overview The MelmarT trial is comparing two surgical approaches for melanoma: one group will have their cancer removed with a smaller margin (1cm) around where the tumor was, while another group will have it removed with a larger margin (2cm). The goal is to see if smaller margins are just as effective without affecting survival.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A Wide Local Excision = 1cm MarginExperimental Treatment1 Intervention
ARM A: Experimental Arm Wide Local Excision = 1cm Margin + Sentinel Lymph Node Biopsy +/- Reconstruction
Group II: Arm B Wide Local Excision = 2cm MarginActive Control1 Intervention
ARM B:Control Arm Wide Local Excision = 2cm 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+

Norfolk and Norwich University Hospitals NHS Foundation Trust

Collaborator

Trials
57
Recruited
29,800+

Peter MacCallum Cancer Centre, Australia

Collaborator

Trials
102
Recruited
23,700+

Published Research Related to This Trial

Only 6% of patients had positive histological margins after wide local excision (WLE) of cutaneous melanoma, but those with positive margins were typically older, had thicker tumors, and often had tumors located in the head and neck region.
Patients with positive margins at WLE had a significantly higher local recurrence rate (16.0%) compared to those with negative margins (6.9%), indicating the importance of achieving clear margins, especially in patients with identified risk factors.
Risk Factors Predicting Positive Margins at Primary Wide Local Excision of Cutaneous Melanoma.Mangold, AR., Skinner, R., Dueck, AC., et al.[2017]
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]
Routine wide local excision (WLE) for stage I/II cutaneous melanoma shows no significant benefit in overall survival compared to omitting the procedure, based on a review of six large trials.
WLE is associated with considerable postoperative morbidity, and evidence suggests that a complete diagnostic excision may be sufficient, warranting further research to potentially change current surgical practices.
The end of wide local excision (WLE) margins for melanoma ?Zijlker, LP., Eggermont, AMM., van Akkooi, ACJ.[2023]

Citations

Risk Factors Predicting Positive Margins at Primary Wide Local Excision of Cutaneous Melanoma. [2017]
Risk factors for positive or equivocal margins after wide local excision of 1345 cutaneous melanomas. [2017]
The end of wide local excision (WLE) margins for melanoma ? [2023]
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]
Reducing margins of wide local excision in head and neck melanoma for function and cosmesis: 5-year local recurrence-free survival. [2015]
Recurrence Rates Over 20 Years in the Treatment of Malignant Melanoma: Immediate Versus Delayed Reconstruction. [2020]
Wide Excisional Surgery in Invasive Melanoma Treatment: Factors Driving Non-compliance With National Guidelines. [2020]
Recommended width of excision for primary malignant melanoma. [2019]
Excision Margin and Survival in Patients with High-Risk, Primary Cutaneous Melanoma: A Retrospective Study Based on Surveillance Epidemiology and End Result (SEER) Database. [2023]
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