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 Details — Status: Recruiting

Administrative data

• NCT number: NCT05445752
• Other study ID #: MELCONSURG
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2022
• Source: Hospital Universitario Virgen Macarena
• Contact: David Moreno-Ramírez, PhD, Prof.
• Phone: 0034697959068
• Email: david.moreno.ramirez.sspa[@]juntadeandalucia.es
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma
• Melanoma Stage III

Locations

Country	Name	City	State
Spain	Dermatology Department. University Hospital Virgen Macarena	Seville

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Virgen Macarena

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nodal relapse-free survival	The primary outcome measure is the frequency and time to develop recurrence in the same nodal basin.	3-year
Secondary	Disease-free survival	Frequency and time to develop recurrence at any site, both regional or at distance.	3-year
Secondary	Melanoma-specific survival	Frequency and time to death directly related to melanoma progression.	3-year
Secondary	Surgical complication rate	Frequency of long-term complications (seroma, lymphedema, nerve injury, others). health-related quality of life questionnaire.	3-year
Secondary	Quality of life	Quality of life as tested by the SF-36 health-related quality of life questionnaire.	3-year