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

NCT05445752 | Unknown

• 1 other identifier: MELCONSURG
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma Stage III

Keywords

Surgery; Lymph node dissection; Conservative nodal surgery; Lymph node metastasis; Melanoma; Stage III melanoma

Outcome Measures

Primary Outcomes (1)

• Nodal relapse-free survival

  The primary outcome measure is the frequency and time to develop recurrence in the same nodal basin.

  3-year

Secondary Outcomes (4)

• Disease-free survival

  3-year

• Melanoma-specific survival

  3-year

• Surgical complication rate

  3-year

• Quality of life

  3-year

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Virgen Macarena: lead

Study Sites (1)

Dermatology Department. University Hospital Virgen Macarena

Seville, 41008, Spain

RECRUITING

MeSH Terms

Conditions

Melanoma; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

David Moreno-Ramírez, PhD, Prof.

CONTACT

0034697959068; david.moreno.ramirez.sspa@juntadeandalucia.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 6, 2022
• Study Start: July 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 6, 2022

Record last verified: 2022-06

Locations

ES (1)