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.
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.
None
Parallel
Adjuvant Therapy
Procedure/SurgeryReceive adjuvant therapy
Comprehensive Geriatric Assessment
Other interventionAncillary studies
Computed Tomography
Procedure/SurgeryUndergo CT
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Questionnaire Administration
Other interventionAncillary studies
Sentinel Lymph Node Biopsy
Procedure/SurgeryUndergo SLN biopsy
Surveillance
BehavioralUndergo surveillance of nodal basin
Ultrasound Imaging
Procedure/SurgeryUndergo ultrasound
Wide Local Excision
Procedure/SurgeryUndergo WLE
Recurrence free survival (RFS) rate
Will evaluate RFS rate. Will compare the co-primary endpoints in a hierarchical manner starting with RFS rate. The 2-year RFS rate will be estimated from the Kaplan-Meier curve and compared between treatment arms via two sample binomial test, and the 95% confidence interval (CI) will be provided. Will be measured on the intention-to-treat patient cohort. Patients that have not had an event reported at analysis will be censored at their date of last follow-up. Patients who drop out or are lost to follow up before 2 years will be censored.
Patient reported outcome (PRO)
Will compare the co-primary endpoints in a hierarchical manner starting with RFS rate. If RFS rate in non-inferior (wide local incision \[WLE\] is non-inferior to WLE plus sentinel lymph node biopsy) will proceed to evaluate PRO as a co-primary endpoint. Will measure patients quality of life by Functional Assessment of Cancer Therapy-Melanoma (FACT-M) score. The FACT-M score change will be calculated by FACT-M score at 2 years minus the FACT-M score at baseline. Descriptive analyses will be conducted for baseline scores, 2-year scores and the change. The change scores will be compared between the two study arms with two sample t test. 95% CI will be provided. If RFS rate is inferior will proceed to evaluate PRO as an exploratory endpoint.
RFS
Will evaluate RFS. Will be measured on the intention-to-treat patient cohort. Survival analyses will be performed using the Kaplan-Meier curve and compared between the two treatment arms by stratified log-rank test. Estimates at 2 years will be summarized along with median time for those events that reach a median survival at or before 2 years.
Overall Survival (OS)
Will evaluate OS. Will be measured on the intention-to-treat patient cohort. Survival analyses will be performed using the Kaplan-Meier curve and compared between the two treatment arms by stratified log-rank test. Estimates at 2 years will be summarized along with median time for those events that reach a median survival at or before 2 years.
Melanoma-specific survival (MSS)
Will evaluate MSS. Will be measured on the intention-to-treat patient cohort. Survival analyses will be performed using the Kaplan-Meier curve and compared between the two treatment arms by stratified log-rank test. Estimates at 2 years will be summarized along with median time for those events that reach a median survival at or before 2 years. Patients who have not died will be censored at the date last known to be alive.
Incidence of adverse events (AEs)
Will evaluate AEs. All subjects will be included in the safety analysis, with toxicities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events. Incidence tables will be generated to summarize incidence of patients reporting at least one episode of each specific AE, incidence of AEs causing withdrawals and incidence of serious AEs. Listing of AEs by patients will include the time to onset, the duration of each event, the severity of each event, and the relationship of the event to study therapy, whether it was a serious event, and whether it caused withdrawal.
Treatment effect
Will estimate treatment effect and the corresponding 95% CIs if computable.
Primary outcome treatment effect
Will estimate the primary outcome treatment effect and the corresponding 95% CIs by sex.
Primary outcome treatment effect
Will estimate the primary outcome treatment effect and the corresponding 95% CIs by race.
Primary outcome treatment effect
Will estimate the primary outcome treatment effect and the corresponding 95% CIs by ethnicity.
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