Actively Recruiting
Excision of Lymph Node Trial (EXCILYNT) (Mel69)
Led by Craig L Slingluff, Jr · Updated on 2025-09-17
66
Participants Needed
7
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Excision of Lymph Node Trial (EXCILYNT) (Mel69)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form.
- Willingness to comply with all study procedures and be available for the study duration.
- Male or female, age 18 years or older.
- ECOG performance status between 0 and 2.
- Histologically or cytologically confirmed metastatic melanoma in only one lymph node in the axilla, groin, or iliac basin detected clinically.
- Clinically positive lymph node defined by palpation or imaging and confirmed by biopsy.
- Ability to undergo lymph node excision surgery.
- If prior metastatic melanoma to a sentinel node in the same basin, at least 1 year since that biopsy without complete lymph node dissection.
- Required radiological studies including PET-CT and head CT or MRI to rule out other metastases.
You will not qualify if you...
- Prior complete lymph node dissection or radiation therapy of the affected lymph node basin.
- Presence or history of in-transit or satellite metastases from the same primary melanoma with metastasis to the studied lymph node, except if no recurrence within the past year.
- One or more metastases distant to the primary draining lymph node basin, except small indeterminate lesions.
- Pre-existing lymphedema that prevents assessment.
- Planned adjuvant radiation therapy to the involved node basin.
- Medical contraindications or inability to comply with protocol requirements.
- Receiving systemic or intratumoral therapy for melanoma within 3 months before enrollment, except certain neoadjuvant therapy cases.
- Prior or concurrent malignancy that could interfere with safety or efficacy assessments.
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Trial Site Locations
Total: 7 locations
1
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
University of Maryland
Baltimore, Maryland, United States, 21201
Not Yet Recruiting
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
5
Duke University Health System
Durham, North Carolina, United States, 27710
Actively Recruiting
6
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
7
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
S
Samantha Schaeffer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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