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Procedure

Surgical Excision Margins for Melanoma (MelMarT-II Trial)

N/A
Recruiting
Research Sponsored by Melanoma and Skin Cancer Trials Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 and subsequent histopathological analysis
Patients must have an ECOG performance score between 0 and 1
Must not have
Planned adjuvant radiotherapy to the primary melanoma site after Wide Local Excision
Patient unable or ineligible to undergo staging sentinel lymph node biopsy of the primary index lesion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3, 6, 12 & 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a less radical surgery is just as effective as a more radical surgery for melanoma.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects from the surgeries may include pain, infection, scarring, and complications related to anesthesia. However, these will vary based on individual patient factors and surgical outcomes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My skin cancer is at an early stage but deep or ulcerated.
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I can carry out all my usual activities without help.
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I am 18 years old or older.
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I had surgery for my condition within 4 months of being diagnosed.
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A 2cm clear area can be safely removed around my melanoma or biopsy scar.
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My melanoma is on the skin, including sensitive areas like the scalp or sole.
Select...
A 2cm clear area can be safely removed around my melanoma or biopsy scar.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for radiation therapy at the melanoma site after surgery.
Select...
I cannot have or am not eligible for a specific lymph node biopsy.
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I had surgery to remove lymph nodes affected by melanoma.
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My melanoma has spread beyond the original site.
Select...
I have had an organ transplant.
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I haven't had any other cancer types in the last 5 years, except for certain exceptions.
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My melanoma is classified as desmoplastic or neurotropic.
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My melanoma is in a specific part of my body.
Select...
I have melanoma under my nail.
Select...
I haven't taken immunosuppressive drugs in the last 6 months.
Select...
I have had surgery to remove a large area around my primary cancer site.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3, 6, 12 & 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6, 12 & 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease-Free Survival
Secondary study objectives
Distant Disease-Free Survival
Health Economic Evaluation
Health-related Quality of Life: EQ-5D-5L questionnaire
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Find a Location

Who is running the clinical trial?

Zuyderland Medical CentreOTHER
23 Previous Clinical Trials
102,436 Total Patients Enrolled
Norfolk and Norwich University Hospitals NHS Foundation TrustOTHER
54 Previous Clinical Trials
26,434 Total Patients Enrolled
Canadian Cancer Trials GroupNETWORK
132 Previous Clinical Trials
66,869 Total Patients Enrolled

Media Library

Wide Local Excision = 1cm Margin (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03860883 — N/A
Cutaneous Melanoma Research Study Groups: Arm A (Wide Local Excision = 1cm Margin), Arm B (Wide Local Excision = 2cm Margin)
Cutaneous Melanoma Clinical Trial 2023: Wide Local Excision = 1cm Margin Highlights & Side Effects. Trial Name: NCT03860883 — N/A
Wide Local Excision = 1cm Margin (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03860883 — N/A
~1499 spots leftby Dec 2029
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