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

Sponsor

Hospital Universitario Virgen Macarena (Other)

Overall Status

Recruiting

CT.gov ID

NCT05445752

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma Stage III

Study Design

Study Type:

Observational

Anticipated Enrollment :

68 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Outcome Measures

Primary Outcome Measures

Nodal relapse-free survival [3-year]
The primary outcome measure is the frequency and time to develop recurrence in the same nodal basin.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

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.