Finding studies
Finding studies
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Lead
ECOG-ACRIN Cancer Research Group
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.
Age
75–any
Sex
ALL
Healthy volunteers
Not accepted
