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

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.

Study Overview

• Status: Recruiting
• Conditions: Melanoma Stage III

• Study Type: Observational
• Enrollment (Anticipated): 68

Contacts and Locations

• Study Contact: Name: David Moreno-Ramírez, PhD, Prof.; Phone Number: 0034697959068; Email: david.moreno.ramirez.sspa@juntadeandalucia.es

Study Locations

• Spain
  • Seville, Spain, 41008
    • Recruiting
    • Dermatology Department. University Hospital Virgen Macarena
    • Contact: David Moreno-Ramírez, PhD, Prof.; Phone Number: 0034697959068; Email: david.moreno.ramirez.sspa@juntadeandalucia.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Melanoma patients (stage III N1b or N2b) fulfilling inclusion criteria and with no exclusion criteria managed at any of the participant centers.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Universitario Virgen Macarena

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Surgery; Melanoma; Lymph node dissection; Stage III melanoma; Conservative nodal surgery; Lymph node metastasis
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: MELCONSURG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No