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Lymph Node Removal Timing for Melanoma (EXCILYNT Trial)
N/A
Recruiting
Led By Craig L Slingluff, Jr., MD
Research Sponsored by Craig L Slingluff, Jr
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 3 years after the lymph node excision
Awards & highlights
No Placebo-Only Group
Summary
This trial will look at if removing a cancerous lymph node is effective at preventing cancer from returning & what side effects the surgery may have.
Who is the study for?
This trial is for adults with melanoma that has spread to only one lymph node, which can be removed by surgery. They must have good performance status (able to carry out daily activities), no prior complete lymph node dissection or radiation in the affected area, and no other cancer treatments within 3 months before joining.
What is being tested?
The study tests whether removing a single cancerous lymph node before or after neoadjuvant systemic therapy prevents cancer recurrence in the same area. It also examines the surgery's side effects and its impact on patients' quality of life.
What are the potential side effects?
Potential side effects include complications from surgery such as infection, pain at the surgical site, swelling (lymphedema), and general risks associated with anesthesia during the operation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years after the lymph node excision
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years after the lymph node excision
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Node basin-only recurrence
Secondary study objectives
Lymphedema
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2: Excision of cLN after neoadjuvant systemic therapyExperimental Treatment1 Intervention
Excision of the clinically detected metastatic lymph node after systemic neoadjuvant therapy.
Group II: Cohort 1: Excision of cLN before systemic therapyExperimental Treatment1 Intervention
Excision of the clinically detected metastatic lymph node before systemic therapy.
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Who is running the clinical trial?
Craig L Slingluff, JrLead Sponsor
23 Previous Clinical Trials
680 Total Patients Enrolled
18 Trials studying Melanoma
575 Patients Enrolled for Melanoma
Craig L Slingluff, Jr., MDPrincipal InvestigatorUniversity of Virginia
2 Previous Clinical Trials
91 Total Patients Enrolled
2 Trials studying Melanoma
91 Patients Enrolled for Melanoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can have a lymph node exam and am not in a trial needing total lymph node removal.I had a suspicious lymph node removed recently, which may not have been checked with a PET-CT.My doctor plans to give me radiation therapy after surgery to the area where my cancer was.I already have lymphedema that cannot be further assessed.I have had all lymph nodes removed or radiation on the affected area.I have or had skin cancer spread to nearby lymph nodes from the same original melanoma.I have or had cancer spread beyond the nearest group of lymph nodes.I have not had melanoma treatment in the last 3 months.I had melanoma spread to a lymph node but didn't have all nodes removed, and it's been over a year.I have had scans to check for melanoma spread and they were clear.I can take care of myself and am up and about more than half of my waking hours.My melanoma has spread to just one lymph node in a specific area.I am 18 years old or older.I have another cancer, but it won't affect this treatment's safety or results.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1: Excision of cLN before systemic therapy
- Group 2: Cohort 2: Excision of cLN after neoadjuvant systemic therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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