This phase III trial compares the effect of wide local excision (WLE) alone to usual care with WLE plus sentinel lymph node (SLN) biopsy for the treatment of older adults with early-stage melanoma. A WLE is a surgical procedure performed to cut out an abnormal lesion and some surrounding normal tissue. This is sometimes followed by a SLN biopsy, in which lymph nodes that tumor cells could spread to are removed as well. Using WLE alone may be just as effective as usual care in treating older adults with early-stage melanoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07068074 .
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PRIMARY OBJECTIVES:
I. To evaluate and compare 2-year recurrence-free survival (RFS) rates in both study arms.
II. To evaluate patient-reported outcomes (PRO) at 2 years (as measured by the change in Functional Assessment of Cancer Therapy-Melanoma [FACT-M] total score) in both study arms.
SECONDARY OBJECTIVES:
I. To evaluate and compare RFS, overall survival (OS), melanoma-specific survival (MSS), safety and PRO (at various endpoints).
II. To evaluate the correlation between practical geriatric assessment (PGA) findings at baseline by domain and study outcomes including RFS, OS, MSS.
III. To evaluate the correlation between changes in PGA scores over the study period and study outcomes including RFS, OS, MSS.
IV. To use the baseline and follow up geriatric assessment (GA) data to develop an assessment tool to allow for future risk assessment for older adults with early-stage melanoma to guide the decision regarding surgical approach.
V. To validate the practical geriatric assessment instrument with data obtained from this study.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo WLE plus SLN biopsy and may undergo surveillance of nodal basin as usual care on study. Patients may receive adjuvant therapy as clinically indicated. Additionally, patients may undergo computed tomography (CT), positron emission tomography (PET)/CT or ultrasound throughout the study.
ARM B: Patients undergo WLE and surveillance of nodal basin on study. Patients may receive adjuvant therapy as clinically indicated. Additionally, patients may undergo CT, PET/CT or ultrasound throughout the study.
After completion of study treatment, patients are followed up every 4 months for 2 years post-randomization and then every 6 months until 5 years post-randomization.
Lead Organization ECOG-ACRIN Cancer Research Group
Principal Investigator Yana Najjar