Narrow vs Wide Excision for Melanoma

Overseen By Wesley Yu, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: OHSU Knight Cancer Institute

Disqualifiers: Metastatic cancer, Pure desmoplastic melanoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Immediate (surgery)

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two surgical methods for removing melanoma, a type of skin cancer. Narrow Excision removes a small amount of healthy skin around the cancer, while Wide Excision removes a larger area. Researchers aim to determine if the smaller removal can be as effective while reducing complications and improving life quality for those with melanoma. Suitable participants have been diagnosed with certain types of melanoma that have not spread and are not pure desmoplastic or mucosal types.

As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could enhance surgical outcomes and quality of life for future melanoma patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that narrow excision, which involves removing a smaller amount of healthy tissue around a melanoma, is generally safe. Studies have found that patients undergoing this procedure often have survival rates similar to those with more extensive tissue removal. This suggests that the narrower approach can effectively treat melanoma without increasing patient risk.

In one study, researchers evaluated 612 patients, some of whom had narrow margin excisions. The results indicated that this did not lead to worse outcomes for these patients. Other studies also suggest that low-risk melanoma can be safely removed with even smaller margins, such as 5 millimeters.

Overall, narrow excision is considered a well-tolerated method for treating certain melanomas. It may also reduce surgical complications and improve quality of life by preserving more healthy tissue. This makes it a promising option for patients seeking effective melanoma treatment with potentially fewer side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial comparing narrow versus wide excision for melanoma because it aims to determine the most effective surgical approach for removing cancerous tissue. Typically, melanoma treatment involves excisions with varied margins to ensure all cancer cells are removed. However, there's uncertainty about how much surrounding healthy tissue needs to be excised to prevent recurrence while minimizing cosmetic and functional impact. This trial could help refine surgical practices, potentially leading to less invasive procedures with similar or improved outcomes for patients.

What evidence suggests that this trial's treatments could be effective for melanoma?

This trial will compare narrow margin excision with wide margin excision for melanoma treatment. Studies have shown that the size of the surgical margin, the border of healthy tissue around a tumor, can affect melanoma treatment outcomes. For smaller excisions, some research suggests that a 1 cm margin can be as safe as a 2 cm margin for certain melanomas, potentially reducing complications while still effectively removing the tumor. However, other studies indicate that a 1 cm margin might not suffice for melanomas deeper than 2 mm, as measured by the Breslow thickness.

Participants in this trial will be assigned to either narrow margin excision or wide margin excision. Using larger margins, known as wide excision, has been a common practice. Some studies have found that wide excision does not significantly alter the chances of cancer recurrence or survival rates compared to smaller margins. Research on wide excision shows that only a small number of patients have leftover tumor cells after surgery. Choosing between narrow and wide excision involves weighing safety against the possibility of fewer surgical complications. ^{4 6 7 8 9}

Who Is on the Research Team?

Wesley Yu

Principal Investigator

OHSU Knight Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults with invasive cutaneous melanoma. It's testing if removing less healthy tissue around the cancer (narrow excision) is as effective as the standard wider removal. Participants should not have other skin conditions that could affect healing.

Inclusion Criteria

My melanoma is early stage with specific high-risk features or is classified as stage IB or IIA.

Participants or legally authorized representatives (LAR) must provide written informed consent before any study-specific procedures or interventions are performed

My melanoma is classified as low risk according to the Merlin Assay.

Exclusion Criteria

I have had surgery to remove the main cancerous area.

My melanoma is mostly desmoplastic (over 90%).

I am scheduled for radiation therapy after melanoma surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo narrow or wide margin excision on study. Blood samples may be collected.

Immediate (surgery)

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

Visits at 1 week, 3, 6, 12, 36, 48, and 60 months

What Are the Treatments Tested in This Trial?

Interventions

• Narrow Excision
• Wide Excision

Trial Overview The ICEMAN Trial compares narrow surgical excision to wide excision in treating invasive cutaneous melanoma. The study aims to see if taking less surrounding healthy tissue can still effectively remove the cancer while possibly improving recovery and quality of life.

How Is the Trial Designed?

Group I: Arm I (narrow margin excision) Experimental Treatment 3 Interventions

Patients undergo narrow margin excision on study. Patients may optionally undergo blood sample collection throughout the study.

Group II: Arm II (wide margin excision) Active Control 3 Interventions

Patients undergo wide margin excision on study. Patients may optionally undergo blood sample collection throughout the study.

Narrow Excision is already approved in European Union, United States for the following indications:

Approved in European Union as Narrow Excision for:

• Invasive cutaneous melanoma

Approved in United States as Narrow Excision for:

• Invasive cutaneous melanoma

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials

239

Recruited

2,089,000+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation Between Surgical and Histologic Margins in Melanoma Wide Excision Specimens. Friedman, EB., Dodds, TJ., Lo, S., et al.[2019]

A study involving 128 clinicians revealed significant variation in the technique of wide local excision (WLE) for melanoma, with most learning their methods informally from colleagues rather than standardized guidelines.

The differences in practice, such as how margins are marked and whether 'dog ears' are sent for histology, suggest that inconsistent WLE techniques could potentially affect patient outcomes, highlighting the need for a consensus statement to standardize practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variation in the practice of wide local excision for melanoma in Ireland and the United Kingdom: a questionnaire survey. O'Connor, E., O'Connor, C., O'Connell, G., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The end of wide local excision (WLE) margins for melanoma ? Zijlker, LP., Eggermont, AMM., van Akkooi, ACJ.[2023]

A study involving 612 patients with thin malignant melanomas (no thicker than 2 mm) found that narrow excision (1-cm margins) is as effective as wide excision (3 cm or more) in preventing the development of metastatic disease and achieving similar disease-free and overall survival rates over a mean follow-up of 55 months.

Narrow excision demonstrated a very low rate of local recurrences, particularly in patients with melanomas thinner than 1 mm, suggesting it is a safe and effective treatment option for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thin stage I primary cutaneous malignant melanoma. Comparison of excision with margins of 1 or 3 cm. Veronesi, U., Cascinelli, N., Adamus, J., et al.[2006]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for positive or equivocal margins after wide local excision of 1345 cutaneous melanomas. Miller, CJ., Shin, TM., Sobanko, JF., et al.[2017]

Mohs micrographic surgery (MMS) significantly reduces local recurrence rates of melanoma in the head and neck compared to wide local excision (WLE), based on a 10-year study of 388 patients.

Patients with in situ or thin invasive melanomas treated with MMS showed even better local recurrence outcomes, highlighting the effectiveness of MMS, especially for tumors located in high-risk areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit of Mohs Micrographic Surgery Over Wide Local Excision for Melanoma of the Head and Neck: A Rational Approach to Treatment. Demer, AM., Vance, KK., Cheraghi, N., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency of residual melanoma in wide local excision (WLE) specimens after complete excisional biopsy. Bolshinsky, V., Lin, MJ., Serpell, J., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4737890/

Wide versus narrow excision margins for high-risk, primary ... Our findings suggest that a 1 cm excision margin is inadequate for cutaneous melanoma with Breslow thickness greater than 2 mm on the trunk and limbs.

2. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/400669

Excision Margins for Primary Cutaneous Melanoma Objective To determine the effectiveness of wide vs narrow excision margins in the treatment of primary cutaneous melanoma. Data Sources We conducted a ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03860883

NCT03860883 | Melanoma Margins Trial-II: 1cm v 2cm ... 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 ...

4. academic.oup.com academic.oup.com/bjsopen/article/9/3/zraf042/8126311

Excision margins and prognosis in cutaneous melanoma The impact of surgical excision margin size on the survival of patients with cutaneous melanoma (CM) is controversial.

5. cureus.com cureus.com/articles/363140-comparison-of-1-cm-versus-2-cm-excision-margins-for-cutaneous-melanoma-a-systematic-review-and-meta-analysis

Comparison of 1-cm Versus 2-cm Excision Margins for ... This systematic review and meta-analysis suggests that a 1 cm margin is as safe as a 2 cm margin for intermediate to thick melanomas, reducing ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/2009058/

Narrow excision (1-cm margin). A safe procedure for thin ... Data for 612 patients were assessable; 305 were randomized to receive 1-cm-margin excision and 307 to receive wide excision (margins of greater than or equal to ...

7. facs.org facs.org/for-medical-professionals/news-publications/news-and-articles/acs-brief/september-10-2024-issue/low-risk-melanoma-lesions-can-be-excised-safely-with-5-mm-margin/

Low-Risk Melanoma Lesions Can Be Excised Safely with 5 ... These melanomas were small and occurred in low-risk body sites. They concluded that low-risk lesions could be safely excised with a 5 mm margin.

8. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/595029

Narrow Excision (1-cm Margin): A Safe Procedure for Thin ... We analyzed the results at 8 years of an international, randomized, prospective study carried out by the World Health Organization Melanoma Programme.

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa030681

Excision Margins in High-Risk Malignant Melanoma We conducted a multicenter clinical trial to investigate the effect of the margin of excision on the outcome in patients with high-risk malignant melanoma.