Older adults with early-stage melanoma: WLE alone vs. WLE with SLN biopsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 3 trial, participants aged 75 and older with newly diagnosed early-stage cutaneous melanoma are randomized to receive either wide local excision alone or wide local excision with sentinel lymph node biopsy, followed by usual surveillance. The study measures 2-year recurrence-free survival and patient-reported outcomes, with secondary goals including overall and melanoma-specific survival, safety, and the relationship between geriatric assessments and outcomes. Additional analyses aim to develop and validate a geriatric risk assessment tool to guide surgical decisions. Imaging and surveillance procedures may be used as clinically indicated in both arms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient must be ≥ 75 years of age.
* Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible.
* Patient must have newly diagnosed primary cutaneous melanoma with wide local excision (WLE) and sentinel lymph node (SLN) biopsy indicated per the treating physician, pending definitive surgical management.

  * NOTE: For WLE and SLN to be indicated, the patient must have either:

    * Pathologic features that include ≧ Breslow 0.8 mm OR Breslow \< 0.8 mm determined at initial biopsy, with a positive margin, ulceration, lymphovascular invasion, perineural invasion or \> 1 mitosis/mm\^2.

OR

* Risk of SLN metastasis of at least 5%, as calculated using the Melanoma Institute of Australia (MIA) Sentinel Node Metastasis Prediction Tool.

  * Patient must be eligible for WLE and SLN biopsy. Patients for whom SLN biopsy would be contraindicated, difficult to perform (i.e., after prior surgery in the draining basin) or impossible (i.e., after prior lymphadenectomy for another cause) are not eligible.
  * Patient must be eligible for surgery and not have uncontrolled medical condition that in the opinion of the medical or surgical oncologist precludes surgical management.
  * Patient must not have an active infection that precludes enrollment to this study in opinion of treating investigator.
  * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial.
  * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients should be class 2B or better.
  * Patient must be English speaking to be eligible for this study in order to complete the patient-reported outcomes (PROs).

    * NOTE: Sites cannot translate the associated quality of life (QOL) forms.

Where it's running

• University of Alabama at Birmingham Cancer Center
  Birmingham, Alabama, United States Recruiting
• Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
  Daphne, Alabama, United States Recruiting
• Thomas Hospital
  Fairhope, Alabama, United States Recruiting
• Mobile Infirmary Medical Center
  Mobile, Alabama, United States Recruiting
• Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
  Saraland, Alabama, United States Recruiting
• Fairbanks Memorial Hospital
  Fairbanks, Alaska, United States Recruiting

+131 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Yana Najjar — ECOG-ACRIN Cancer Research Group

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.