Wide Local Excision for Skin Cancer

Overseen By Yana Najjar, MD

Age: 65+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eastern Cooperative Oncology Group

Disqualifiers: Active infection, Cardiac disease, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 4 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if treating melanoma with only a wide local excision (WLE)—a surgery that removes the cancer and some surrounding tissue—is as effective as combining it with a sentinel lymph node (SLN) biopsy. Typically, care includes both WLE and SLN biopsy to check for cancer spread, but this study tests whether WLE alone can suffice while potentially enhancing overall well-being. It seeks patients aged 75 or older with newly diagnosed melanoma who qualify for both WLE and SLN biopsy. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients the opportunity to contribute to potentially groundbreaking treatment advancements.

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 team or your doctor.

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

Research has shown that wide local excision (WLE) for melanoma is generally safe and well-tolerated. Studies indicate that WLE leaves behind melanoma cells in only 0% to 4.2% of cases, demonstrating its effectiveness in removing cancerous tissue.

WLE is a standard treatment with a long history of safe use in clinical settings. Although other surgical methods, such as Mohs surgery, might yield slightly better results in some cases, WLE remains a dependable choice for many patients.

Overall, WLE is considered a safe procedure with a low risk of complications, making it a common approach for treating melanoma. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the wide local excision (WLE) approach for skin cancer because it potentially offers a more targeted method of treatment. Unlike standard care options that might involve more extensive surgery or additional therapies, WLE focuses on removing the cancerous tissue with a margin of healthy tissue, which may reduce the chance of recurrence. The trial is comparing two methods: one where WLE is combined with sentinel lymph node (SLN) biopsy, and another where WLE is performed alone. This study aims to determine if WLE alone could be sufficient, possibly leading to less invasive treatment with similar outcomes, which is a significant factor for patient recovery and quality of life.

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

Research shows that a wide local excision (WLE), which involves removing the melanoma and some nearby healthy tissue, can effectively treat melanoma. Studies indicate that WLE does not significantly lower the risk of cancer recurrence if the melanoma has been completely removed. In this trial, participants in Arm B will receive WLE only, with surveillance of the nodal basin. This suggests that WLE alone might suffice for some patients without needing additional procedures like a sentinel lymph node biopsy (SLN). The SLN, part of Arm A, checks for cancer spread by removing some lymph nodes. Other studies support that WLE effectively removes cancer cells, as confirmed by lab research. Overall, WLE is a well-established method for treating melanoma and could be an effective treatment on its own in certain cases. ^{1 3 4 6 7}

Who Is on the Research Team?

Yana Najjar, MD

Principal Investigator

UPMC Hillman Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals aged 75 or older with newly diagnosed primary cutaneous melanoma. They must be fit for surgery, not have certain medical conditions that would make the procedure risky, and able to understand and consent to the study. People with active infections or severe heart issues are excluded.

Inclusion Criteria

I have a new skin melanoma diagnosis and am waiting for surgery.

I am eligible for a specific type of breast surgery and lymph node biopsy.

I am fit for surgery and don't have any health issues that would make surgery unsafe.

Exclusion Criteria

Patient must not have an active infection that precludes enrollment to this study in opinion of treating investigator.

I am HIV positive, on treatment, and my viral load is undetectable.

My heart function is classified as class 2B or better, despite my history of cardiac issues or treatments.

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 (WLE) with or without Sentinel Lymph Node (SLN) biopsy, followed by nodal basin surveillance

4 months

Regular visits for surgical procedures and surveillance

Surveillance

Participants are monitored for recurrence-free survival (RFS) and patient-reported outcomes (PRO) with Geriatric Assessment (GA) and FACT-M Quality of Life (QOL) assessments

24 months

Visits at baseline, 4, 8, 12, 16, 20, and 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Sentinel Lymph Node Biopsy
• Wide Local Excision

Trial Overview The study is testing if performing only a wide local excision (WLE) is as effective as combining WLE with a sentinel lymph node (SLN) biopsy in treating early-stage melanoma in elderly patients. It aims to see if this could improve overall well-being compared to usual care.

How Is the Trial Designed?

Group I: Arm B Experimental Treatment 1 Intervention

WLE only, with surveillance of nodal basin

Group II: Arm A Active Control 1 Intervention

WLE and SLN biopsy with surveillance of nodal basin

Who Is Running the Clinical Trial?

Eastern Cooperative Oncology Group

Lead Sponsor

Trials

272

Recruited

153,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10930506/

A Review of Contemporary Guidelines and Evidence for Wide ... Although a wider local excision margin around the primary tumour may in theory maximize the chance of cure, the result is a larger wound that ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0959804925001479

does wide local excision after a complete diagnostic ... WLE does not significantly reduce the risk of tumour recurrence in patients with completely excised cutaneous melanoma. Abstract. Objectives.

3. jamanetwork.com jamanetwork.com/journals/jamadermatology/article-abstract/2830249

Mohs Surgery vs Wide Local Excision in Primary High ... This cohort study assesses the outcomes of primary high-stage cutaneous squamous cell carcinoma among patients treated with Mohs surgery ...

4. karger.com karger.com/drm/article/239/6/877/862802/Survival-Outcomes-of-Mohs-Surgery-versus-Wide

Survival Outcomes of Mohs Surgery versus Wide Local ... Finally, the year at diagnosis, age, sex, tumor site, tumor histological type, previous malignancy history, the total number of malignant tumors, tumor stage, ...

5. ejcancer.com ejcancer.com/article/S0959-8049(22)01331-4/fulltext

The end of wide local excision (WLE) margins for melanoma Therefore, indirect evidence for the benefit of WLE can be found in pathological research describing the occurrence of malignant melanoma cells ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0959804922013314

The end of wide local excision (WLE) margins for melanoma Pathology studies showed a low incidence of residual melanoma in WLE specimen (0–4.2%). Mohs surgery does not show a difference in recurrence rates or OS. WLE ...

7. facs.org facs.org/for-medical-professionals/news-publications/news-and-articles/acs-brief/june-10-2025-issue/mohs-surgery-outperforms-wide-local-excision-in-high-grade-squamous-cell-skin-cancer-treatment/

Mohs Surgery Outperforms Wide Local Excision in High- ... Median follow up was 33 months. Local recurrence (19.8% vs 9.6%) and metastasis (17.9% vs 11%) were observed more often in patients treated ...