Conservative Nodal Surgery (Node-picking) of Patients With Stage III Melanoma With Low-burden of Nodal Disease (MELCONSURG MULTICENTRE COHORT)

Study Overview
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Brief Summary
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Background: Standard treatment for stage III melanoma with lymph node metastases involves complete lymph node dissection, which is a radical surgical procedure aimed at the removal of the entire regional lymph node basin. Conservative surgery for low-burden nodal metastasis involves removal of the metastatic lymph node or nodes (node-picking), leaving uninvolved nodes within the regional basin. This is expected to provide adequate regional control of the disease with no negative impact on patient survival and a lower rate of surgical complications. Aims: The MelConSurg Cohort will provide the first data on conservative surgery for patients with stage III melanoma with nodal metastases detected clinically or by imaging. Methods: A multicentre, single-arm prospective cohort study. Inclusion criteria: Patients with melanoma aged between 18 and 90 years, Eastern Cooperative Oncology Group performance status 0-1, non-matted regional lymph node metastasis (N1b or N2b) in a single regional basin detected clinically or by imaging (ultrasound, CT scan, PET scan). Study period: A 3-year recruitment period and a 3-year follow-up phase. Intervention: Patients will undergo conservative nodal surgery using conventional surgery, radio-guided surgery, or imaging guided surgery. Outcome measures: 3-year nodal relapse-free survival, 3-year disease-free survival, 3-year melanoma-specific survival, rate of surgical complications, and quality of life (SF-36 questionnaire). Sample size & Statistics: the estimated sample size to be recruited is 68 patients. Survival outcomes will be analysed through the Kaplan-Meier method, with the log-rank test. Conclusions: This Project is expected to provide unique evidence regarding a less radical nodal surgery for patients with melanoma. If favourable results are obtained, controlled studies could be conducted and changes in current clinical practice could be considered.

Official Title
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Conservative Nodal Surgery (Node-picking) of Patients With Stage III Melanoma With Low-burden of Nodal Disease (MELCONSURG MULTICENTRE COHORT)

Conditions
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Melanoma Stage III

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with melanoma aged between 18 and 90 years. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Nodal stage N1b or N2b (American Joint Committee on Cancer 8th edition) in a single regional basin detected clinically or by imaging (ultrasound, CT scan, PET scan). Exclusion Criteria: Single lymph node metastasis in more than one regional basin. Multiple primary melanoma (except for limb melanoma). Primary occult melanoma. Previous nodal, locoregional, or distant metastasis. Previous lymph node surgery, except for SLNB. Distant metastases detected at the screening evaluations or first postoperative PET-CT scan.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nodal relapse-free survival | The primary outcome measure is the frequency and time to develop recurrence in the same nodal basin. | 3-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | Frequency and time to develop recurrence at any site, both regional or at distance. | 3-year | 
| Melanoma-specific survival | Frequency and time to death directly related to melanoma progression. | 3-year | 
| Surgical complication rate | Frequency of long-term complications (seroma, lymphedema, nerve injury, others). health-related quality of life questionnaire. | 3-year | 
| Quality of life | Quality of life as tested by the SF-36 health-related quality of life questionnaire. | 3-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Lymph node dissection, Conservative nodal surgery, Lymph node metastasis, Melanoma, Stage III melanoma