Conservative Nodal Surgery (Node-picking) of Patients With Stage III Melanoma With Low-burden of Nodal Disease (MELCONSURG MULTICENTRE COHORT)
- Conditions
- Melanoma Stage III
- Registration Number
- NCT05445752
- Lead Sponsor
- Hospital Universitario Virgen Macarena
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 68
- 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).
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method Surgical complication rate 3-year Frequency of long-term complications (seroma, lymphedema, nerve injury, others). health-related quality of life questionnaire.
Melanoma-specific survival 3-year Frequency and time to death directly related to melanoma progression.
Disease-free survival 3-year Frequency and time to develop recurrence at any site, both regional or at distance.
Quality of life 3-year Quality of life as tested by the SF-36 health-related quality of life questionnaire.
Trial Locations
- Locations (1)
Dermatology Department. University Hospital Virgen Macarena
🇪🇸Seville, Spain