Excision of Lymph Node Trial (EXCILYNT) (Mel69)

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Craig L Slingluff, Jr
Study ID
NCT05839912
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Excision of clinically detected lymph node metastasis before any systemic therapy — PROCEDURE
    Surgical intervention to remove the clinically detected lymph node metastasis after which physician choice adjuvant systemic therapy is permitted
  • Excision of clinically detected lymph node metastasis after neoadjuvant systemic therapy — PROCEDURE
    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

Study Details

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.

Key Dates

Start date
Sep 6, 2023
Status verified
Sep 2025
Primary completion
Sep 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
66 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Excision of cLN before systemic therapy
    Excision of the clinically detected metastatic lymph node before systemic therapy.
  • Experimental: Cohort 2: Excision of cLN after neoadjuvant systemic therapy
    Excision of the clinically detected metastatic lymph node after systemic neoadjuvant therapy.

Primary Outcome Measure

Node basin-only recurrence [ Time Frame: 3 years after the lymph node excision ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322
Bridney Stewart
[email protected]
404-778-4520
University of MarylandBaltimoreMaryland21201-
University of MichiganAnn ArborMichigan48109-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Duke University Health SystemDurhamNorth Carolina27710
Chandler Warren
[email protected]
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Cancer Center at the University of VirginiaCharlottesvilleVirginia22908-

Find similar trials in Atlanta, GA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Emory University· Atlanta, GAUniversity of Maryland· Baltimore, MDUniversity of Michigan· Ann Arbor, MIMemorial Sloan Kettering Cancer Center· New York, NYDuke University Health System· Durham, NCUniversity of Pennsylvania· Philadelphia, PA

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