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New treatment option for Melanoma
Official title Excision of Lymph Node Trial (EXCILYNT) (Mel69)
ClinicalTrials.gov ID: NCT05839912
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
- people must have histologically (or cytologically) confirmed metastatic melanoma to only one lymph node in the axilla, groin, or iliac basin that was...
You likely can't join if
- people who have had a prior complete lymph node dissection or radiation therapy of the clinically positive node basin.
- people who have, or have had, in-transit or satellite metastases from the same primary melanoma that has metastasized to the cLN that is the focus of...
- people who have, or have had, one or more metastases distant to the primary draining lymph node basin. An individual with small radiologic or...
- people with pre-existing lymphedema that precludes assessment of lymphedema. Pre-existing lymphedema should be discussed with the principal...
- people whose treating physician(s) plan adjuvant radiation therapy to the involved node basin, because that also would confound assessment of node...
- Individuals for whom there is a medical contraindication or potential problem in complying with the requirements of the protocol in the opinion of...
See the full eligibility criteria
- 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
- people 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...
- people must be able to undergo LNEx and must not be on a clinical trial that requires TLND. a. people may have previously had metastatic melanoma to a sentinel node in the same node basin, if complete lymph node...
- 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.
- people who have had a prior complete lymph node dissection or radiation therapy of the clinically positive node basin.
- people who have, or have had, in-transit or satellite metastases from the same primary melanoma that has metastasized to the cLN that is the focus of the current study. a. The only exception are people who have had...
- people who have, or have had, one or more metastases distant to the primary draining lymph node basin. An individual with small radiologic or clinical findings of an indeterminate nature may still be eligible: examples...
- people with pre-existing lymphedema that precludes assessment of lymphedema. Pre-existing lymphedema should be discussed with the principal investigator (PI) at the treating institution or the overall study PI. Some...
- people whose treating physician(s) plan adjuvant radiation therapy to the involved node basin, because that also would confound assessment of node basin recurrence and lymphedema.
- Individuals for whom there is a medical contraindication or potential problem in complying with the requirements of the protocol in the opinion of the investigator.
- people with a prior or concurrent malignancy may be eligible if its natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the regimen.
- people who are receiving systemic or intratumoral therapy for this melanoma within 3 months of enrollment. They may have received prior adjuvant systemic therapy for an earlier stage of disease, but should be off that...
- The only exception is for patients who are being treated at a participating center with neoadjuvant therapy for 1 cLN, and who otherwise meet criteria for enrollment. They should be screened and enrolled as soon as...
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Baltimore, Maryland, United States
- Ann Arbor, Michigan, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Baltimore, Maryland, United States; Ann Arbor, Michigan, United States; New York, New York, United States; Durham, North Carolina, United States; Philadelphia, Pennsylvania, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.