Clinical Trials | A Randomized Phase III Study of Management of Treatment Naive Primary Melanoma in Elderly Patients

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with Early-Stage Melanoma that are eligible for surgery. The purpose of this study is to compare the efficacy of using wide local excision (WLE) alone to the usual treatment, using WLE plus sentinel lymph node (SLN) biopsy. In this study, you will placed into one of two groups: Group 1 If you are in this group, you will get the usual approach used to treat this type of cancer, wide local excision (WLE) plus sentinel lymph node (SLN) biopsy. You may also receive additional medication to treat your melanoma after the WLE and SLNs if recommended by your doctor. There will be about 214 people in this group. Group 2 If you are in this group, you will get wide local excision (WLE) combined with nodal basin surveillance (ultrasound or CT scan) instead of the sentinel node biopsy. You may also receive additional medication to treat your melanoma after the WLE if recommended by your doctor. The study surgery used in this study could have side effects. These side effects are no different from what you would get with the usual approach for your melanoma. Some of the most common side effects that the study doctors know about are: • Infection • Scarring • Bleeding You may or may not benefit as a result of your participation in this study. However, this study may also help doctors learn things that can help other people in the future. After your surgery is completed, your doctor and study team will watch you for recurrence of your melanoma and will ask you to complete surveys to assess your physical well-being and quality of life every 4 months for the first 2 years after you are assigned to your group. After 2 years you will no longer have any more surveys, but you will continue to have visits with your doctor and study team every 6 months for three more years. Additional information found here: Study Details | NCT07068074 | A Randomized Phase III Study of Management of Treatment Naive Primary Melanoma in Elderly Patients | ClinicalTrials.gov For questions, contact: [email protected]