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

Melanoma Stage III Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05445752
Study type Observational
Source Hospital Universitario Virgen Macarena
Contact David Moreno-Ramírez, PhD, Prof.
Phone 0034697959068
Email david.moreno.ramirez.sspa@juntadeandalucia.es
Status Recruiting
Phase
Start date July 1, 2022
Completion date December 31, 2024
View Details
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