Lymph Node Excision (LNEx) for Patients With Stage III Melanoma With One Clinically Positive Node: Excision of Lymph Node Trial [EXCILYNT]
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.
• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, aged 18 years or older at enrollment
• ECOG performance status of 0-2
• 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 that is FDG-avid or ≥ 0.95 cm on PET-CT, based on professional assessment of the radiologist, and that also is confirmed to contain metastatic melanoma on biopsy.
• a) The clinically positive lymph node may have been removed within 8 weeks prior to enrollment, and in that case may or may not have been evaluated by PET-CT; it is considered a clinically positive node if it was either identified as clinically suspicious on exam and/or on preoperative scans based on FDG-avidity and/or diameter ≥ 0.95 cm, and also confirmed histologically. The clinically positive node must be within the primary draining node basin of the primary melanoma, or the metastasis may be from an unknown primary site. A node that was removed at sentinel node biopsy will not meet this eligibility criterion. A patient will not be eligible if there is evidence of an additional clinically positive node on imaging or physical exam after excision of the first clinically positive node.
• Subjects must be able to undergo LNEx and must not be on a clinical trial that requires TLND.
• a. Subjects may have previously had metastatic melanoma to a sentinel node in the same node basin, if complete lymph node dissection was not done, and if at least 1 year has elapsed since the prior positive sentinel node biopsy.
• Individuals will be required to have radiological studies to rule out radiologically evident melanoma metastasis. Required studies include:
‣ PET-CT scan, and
⁃ Head CT scan or MRI These scans may have been performed prior to resection of the primary melanoma and/or sentinel node biopsy if they showed no evidence of other metastases.