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Procedure
Surgical Excision Margins for Melanoma (MelMarT-II Trial)
Phase 3
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 year from randomisation
Awards & highlights
MelMarT-II Trial 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.Check my eligibility
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.See study design
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.
MelMarT-II Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
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.
MelMarT-II Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 1 year from randomisation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 year from randomisation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease-Free Survival
Secondary outcome measures
Adverse Events
Distant Disease-Free Survival
Health Economic Evaluation
+7 moreMelMarT-II 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?
Canadian Cancer Trials GroupNETWORK
124 Previous Clinical Trials
64,455 Total Patients Enrolled
Zuyderland Medical CentreOTHER
21 Previous Clinical Trials
66,236 Total Patients Enrolled
Cancer Trials IrelandNETWORK
84 Previous Clinical Trials
22,636 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for radiation therapy at the melanoma site after surgery.My skin cancer is at an early stage but deep or ulcerated.I cannot have or am not eligible for a specific lymph node biopsy.I had surgery to remove lymph nodes affected by melanoma.I can carry out all my usual activities without help.My melanoma has spread beyond the original site.I am 18 years old or older.I have had an organ transplant.I had surgery for my condition within 4 months of being diagnosed.The doctor thinks you will live for at least 5 more years.I haven't had any other cancer types in the last 5 years, except for certain exceptions.A 2cm clear area can be safely removed around my melanoma or biopsy scar.I had cancer before, was treated with the intent to cure, have been cancer-free for 5 years except for certain skin or cervical cancers, and am considered low risk for recurrence.My melanoma is on the skin, including sensitive areas like the scalp or sole.My melanoma is classified as desmoplastic or neurotropic.My melanoma is in a specific part of my body.I have melanoma under my nail.My skin condition is possibly cancerous but not confirmed.A 2cm clear area can be safely removed around my melanoma or biopsy scar.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.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (Wide Local Excision = 1cm Margin)
- Group 2: Arm B (Wide Local Excision = 2cm Margin)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How large is the test group for this experiment?
"The information available on clinicaltrials.gov does show that this trial is actively recruiting patients as of right now. This trial was initially posted on December 17th, 2019 and the most recent update was October 24th, 2020. They are looking for 2,998 patients in total from 48 different sites."
Answered by AI
Is the FDA's decision to approve Wide Local Excision with a 1cm Margin supported by scientific research?
"Power has given Wide Local Excision = 1cm Margin a safety score of 3. This is based off the fact that it is a phase 3 trial, and thus there is both evidence of efficacy as well as multiple rounds of data supporting safety."
Answered by AI
In how many different locations is this trial being conducted?
"In total, there are 48 patients enrolled in this trial at various locations including VCU Massey Cancer Center in Richmond, Marshfield Medical Center - Marshfield in Marshfield, and University of Kansas Hospital - Indian Creek Campus in Overland Park."
Answered by AI
Is this research available to participants at the present time?
"Yes, the trial is recruiting patients as of now. The date when this study was first posted on clinicaltrials.gov was December 17th, 2019 and the most recent update to the trial information occurred on October 24th, 2020."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
What site did they apply to?
Banner MD Anderson Cancer Center
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