A Randomized Phase III Study of Management of Treatment Naive Primary Melanoma in Elderly Patients
Eastern Cooperative Oncology Group
Summary
Can we treat your melanoma just as effectively without doing a sentinel lymph node (SLN) biopsy in addition to your wide local excision (WLE) procedure? A wide local excision (WLE) is a surgical procedure performed to cut out an abnormal lesion and some surrounding normal tissue. This is sometimes followed by a sentinel lymph node (SLN) biopsy, in which lymph nodes that cancer cells could spread to are removed as well. We are doing this study because we want to find out if performing the WLE alone is just as effective as the usual approach for your melanoma, and if it leads to improvements in patients' overall well-being. The usual approach is defined as care most people get for the early stage of melanoma that you currently have.
Description
This study hypothesizes that WLE plus SLN will not significantly change the 2-year recurrence-free survival (RFS) rate compared to WLE alone for elderly patients, and that de-escalated management will result in superior patient-reported outcomes (PRO). The goal of this study is to obtain clinical outcomes data, both RFS and PRO, on older patients who undergo SOC (WLE and SLN biopsy when indicated) vs. de-escalated surgical management \[WLE only, without SLN biopsy, with nodal basin surveillance (US or CT, per institutional/physician preference)\] of early-stage primary melanoma. A less aggress…
Eligibility
- Age range
- 75+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patient must be ≥ 75 years of age. * Patient must have 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 surgica…
Interventions
- ProcedureWide local Excision
A wide local excision (WLE) is a surgical procedure performed to cut out an abnormal lesion and some surrounding normal tissue.
- ProcedureSentinel Lymph Node and Wide Local Excision
A wide local excision (WLE) is a surgical procedure performed to cut out an abnormal lesion and some surrounding normal tissue. This is sometimes followed by a sentinel lymph node (SLN) biopsy, in which lymph nodes that cancer cells could spread to are removed as well.
Location
- UPMC Hillman Cancer CenterPittsburgh, Pennsylvania