Lymph Node Removal Timing for Melanoma (EXCILYNT Trial)
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Craig L Slingluff, Jr
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
How does the timing of lymph node removal for melanoma differ from other treatments?
This treatment is unique because it involves removing lymph nodes either before or after systemic therapy, depending on when metastasis is detected. Unlike traditional approaches that often involve immediate lymph node removal, this method allows for flexibility based on the patient's response to initial systemic therapy, potentially reducing unnecessary surgery and its complications.
12458Is lymph node removal generally safe for melanoma patients?
Lymph node removal, including procedures like sentinel lymph node biopsy and lymph node dissection, is generally considered safe, but it can have complications. Studies have shown that while these procedures can help in managing melanoma, they may come with risks such as postoperative complications and morbidity (health problems after surgery).
236910What data supports the effectiveness of this treatment for melanoma?
Research shows that removing lymph nodes after neoadjuvant systemic therapy (treatment given before the main treatment) for stage III melanoma does not lead to worse surgical outcomes compared to removing them upfront. Additionally, early intervention with sentinel lymph node biopsy in certain patients can improve long-term survival.
256710Will I have to stop taking my current medications?
The trial requires that participants stop any systemic or intratumoral therapy for melanoma at least 3 months before enrolling. If you are on such treatments, you will need to stop them to participate.
Eligibility Criteria
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.Participant Groups
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.
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.
Excision of clinically detected lymph node metastasis after neoadjuvant systemic therapy is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Lymph Node Excision for:
- Metastatic melanoma
🇪🇺 Approved in European Union as Excision of Clinically Detected Lymph Node Metastasis for:
- Metastatic melanoma
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Cancer Center at the University of VirginiaCharlottesville, VA
Duke University Health SystemDurham, NC
Emory UniversityAtlanta, GA
University of MarylandBaltimore, MD
More Trial Locations
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Who is running the clinical trial?
Craig L Slingluff, JrLead Sponsor
References
Delayed regional lymph node dissection in stage I melanoma of the skin of the lower extremities. [2019]Results of a prospective randomized clinical trial conducted by the WHO Collaborating Centers for the Evaluation of Methods of Diagnosis and Treatment of Melanoma are reported. Five-hundred-fifty-three Stage I patients whose limbs were affected entered the study; 267 were submitted to wide excision and immediate node dissection and 286 had wide excision and node dissection at the time clinically positive nodes were detected. Survival curves of the two treatment groups could be superimposed. No subsets of patients benefitted from immediate node dissection. The authors conclude that delayed node dissection is as effective as the immediate dissection in Stage I melanoma of the extremities if the patient can be checked every three months. If the quarterly follow-up is not guaranteed, immediate node dissection is advisable, at least for melanomas thicker than 2 mm.
[Surgical treatment of malignant melanoma]. [2012]Early diagnosis and total tumor excision are fundamental to assure a favorable outcome in the treatment of the malignant melanoma. Previously a large local excision up to 5 cm was recommended. In the past two decades some prospective studies showed the same survival rate when using narrower margins of excision (1-3 cm). The elective lymphadenectomy increases the survival rate only in a small group of patients and has a high rate of complications. The concept of lymphatic mapping can greatly help in finding the lymph node ("sentinel lymph node") which is the first one to receive lymphatic drainage from the affected area. This node has the highest probability of containing a metastasis and is excised. With this procedure the number of patients requiring lymphadenectomy can be limited to those who have documented lymph node metastases. The sentinel biopsy technique can provide new insight into the tumor biology of melanoma and helps in determining adjuvant therapy. In order to evaluate the influence of sentinel node biopsy on survival rate of melanoma patients clinical trials have been designed. Systemic melanoma metastases carry a poor prognosis. Surgical resection of isolated metastases may provide good palliation, in combination with other therapies.
Adjuvant irradiation for axillary metastases from malignant melanoma. [2022]To evaluate the outcome and treatment-related toxicity for patients with axillary lymph node metastases from malignant melanoma treated with surgery and radiation, with or without systemic therapy.
[The role of surgery in the treatment of cutaneous melanoma]. [2011]Historically, melanoma patients were subject to wide local excisions and elective lymph node dissections. Both approaches were the focus of intense scrutiny in the past three decades, and many surgical dogmas were abolished. The role of surgery in providing local control over the primary tumor is largely undisputed. In addition, the surgical management strategies of the regional lymph nodes have undergone considerable change in the past; with lymphatic mapping and sentinel lymph node identification being the most relevant contribution, allowing selection of patients for adjuvant treatment (completion lymph node dissection, Interferon therapy). Surgery has also a place in palliative treatment of isolated systemic metastases for selected cases with good performance status in Stage IV melanoma.
Surgical management of melanoma. [2014]Surgery remains the mainstay of treatment of every patient in whom complete excision of all disease is feasible. For clinically localized melanoma (clinical stages 0-II), wide excision and, when appropriate, sentinel lymph node biopsy are well established. The management of stage III melanoma is more contentious. Resection remains the first choice of therapy for patients with oligometastatic melanoma in accessible locations, but careful consideration of preoperative use of highly active drugs is appropriate. Decisions regarding surgical management of stage IV melanoma should routinely be made in the context of a multidisciplinary team approach.
Sentinel lymph node biopsy in melanoma: final results of MSLT-I. [2018]In 1994 an international randomized controlled clinical trial, MSLT-I, opened to study the utility of sentinel lymph node biopsy (SLNB) for patients with clinically localized melanoma. This trial compared outcomes of patients treated with wide local excision (WLE) and SLNB (followed by immediate completion lymph node dissection [CLND] for those with a positive sentinel node [SN]) with outcomes of patients treated with WLE alone and CLND upon the development of clinically apparent disease. In February 2014 the final analysis of long-term outcomes data was published. Importantly, these data showed that the rates of nodal positivity were the same between the two arms of the trial. Although no difference in 10-year melanoma-specific survival was noted between the two arms, this was not entirely surprising as the overall rate of nodal disease within the trial was 20.8%, meaning that 79.2% of patients could not derive a benefit from SLNB. Subset analysis was performed to determine the impact of early intervention for those patients most likely to have a benefit from early detection. This analysis showed that for patients with nodal disease and intermediate-thickness melanoma (defined as 1.2-3.5-mm Breslow depth), early treatment following positive SLNB was associated with improved 10-year distant disease-free survival and improved 10-year melanoma-specific survival.
[Significance of lymphadenectomy of "sentinel" lymph nodes in combined treatment of cutaneous melanoma localized on extremities and the trunk]. [2023]There is presented a comparative analysis, performed on immediate and late results of treatment, obtained in patients, suffering cutaneous melanoma, to whom wide excision of primary tumor with lymphadenectomy or radical excision of primary tumor alone were accomplished, basing on a "sentinel" node biopsy data.
Association of surgical interval and survival among hospital and non-hospital based patients with melanoma in North Carolina. [2022]Surgical excision is important for melanoma treatment. Delays in surgical excision after diagnosis of melanoma have been linked to decreased survival in hospital-based cohorts. This study was aimed at quantifying the association between the timeliness of surgical excision and overall survival in patients diagnosed with melanoma in hospital- and non-hospital-based settings, using a retrospective cohort study of patients with stage 0-III melanoma and using data linked between the North Carolina Central Cancer Registry to Medicare, Medicaid, and private health insurance plan claims across the state. We identified 6,496 patients diagnosed between 2004 and 2012 with follow-up through 2017. We categorized the time from diagnostic biopsy to surgical excision as 90 days after melanoma diagnosis. Multivariable Cox regression was used to estimate differences in survival probabilities. Five-year overall survival was lower for those with time to surgery over 90 days (78.6%) compared with those with less than 6 weeks (86%). This difference appeared greater for patients with Stage 1 melanoma. This study was retrospective, included one state, and could not assess melanoma specific mortality. Surgical timeliness may have an effect on overall survival in patients with melanoma. Timely surgery should be encouraged.
Diagnosis and management of cutaneous melanoma. [2023]In the field of melanoma, clinical trials evaluating the impact of sentinel node biopsy, completion lymph node dissection and adjuvant medical therapies on patient outcomes have provided evidence that has changed practice significantly over the past five years.
Surgical outcomes of lymph node dissections for stage III melanoma after neoadjuvant systemic therapy are not inferior to upfront surgery. [2023]Neoadjuvant systemic therapy has shown promising results in the treatment of high-risk stage III melanoma; however, the effects on surgery are currently unknown. This study aims to compare the surgical outcomes, in terms of postoperative complications, postoperative morbidity, duration of surgery and textbook outcomes, of patients with high-risk stage III melanoma who received neoadjuvant systemic therapy followed by lymph node dissection with patients who received an upfront lymph node dissection.