Lymph Node Excision (LNEx) for Patients With Stage III Melanoma With One Clinically Positive Node: Excision of Lymph Node Trial [EXCILYNT]
Craig L Slingluff, Jr
Summary
The purpose of this study is to find out if removing only the cancerous lymph node (known as a lymph node excision) is effective at preventing cancer from coming back in the same area of the lymph node excision. The study team is also trying to find out the side effects of this type of surgery and how much the surgery impacts quality of life. In order to be eligible for this study, participants must have been diagnosed with metastatic melanoma and have one detected cancerous lymph node by imaging (CT/PET scan) or clinical examination, and are a candidate for lymph node excision.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Male or female, aged 18 years or older at enrollment 4. ECOG performance status of 0-2 5. Subjects must have histologically (or cytologically) confirmed metastatic melanoma to only one lymph node in the axilla, groin, or iliac basin that was detected clinically. A clinically positive lymph node is defined as a palpable and clinically suspicious node (based on palpation or imaging), or non-palpable lymph node th…
Interventions
- ProcedureExcision of clinically detected lymph node metastasis before any systemic therapy
Surgical intervention to remove the clinically detected lymph node metastasis after which physician choice adjuvant systemic therapy is permitted
- ProcedureExcision of clinically detected lymph node metastasis after neoadjuvant systemic therapy
Surgical intervention to remove the clinically detected lymph node metastasis after physician choice neo adjuvant systemic therapy. Physician choice adjuvant therapy is allowed after surgery
Locations (7)
- Emory UniversityAtlanta, Georgia
- University of MarylandBaltimore, Maryland
- University of MichiganAnn Arbor, Michigan
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Duke University Health SystemDurham, North Carolina
- University of PennsylvaniaPhiladelphia, Pennsylvania