Randomized Controlled Trial of Selective Index Lymph Node Resection Versus Therapeutic Lymph Node Dissection After Neoadjuvant Immunotherapy for Stage IIIB-D Melanoma
Melanoma Institute Australia
Summary
The goal of this clinical trial is to demonstrate that there is no difference (non-inferiorty) in the 2 year recurrence-free survival (RFS) between 2 different surgical approaches for clinical Stage III melanoma. Following 6 weeks of standard neaodjuvant immunotherapy, patients will undergo either selective index lymph node resection (ILN) (identified at baseline as the largest affected lymph node) or the standard of care therapeutic lymph node dissection (TLND). The secondary aims are to assess if patients who are managed without TLND will have a reduction in surgical complications (less wound problems \& lymphoedema), an improved quality of life, at a lower healthcare utilisation.
Description
The standard treatment under current guidelines for patients who have melanoma that has spread to the lymph nodes (Stage III disease) is a 'therapeutic lymph node dissection' or 'TLND'. This is the removal of all of the lymph nodes in the affected area, such as in the armpit, neck or groin. TLND surgery Several clinical trials over the past 10 to 15 years have shown that treatment with immune system boosting drugs (known as immunotherapy) can help the body to better identify and attack the tumour cells. This is now used routinely for tumour that has spready beyond the lymph nodes (Stage IV di…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female patients ≥ 18 years of age at the time of consent 2. Written informed consent 3. Cytologically or histologically confirmed, resectable pathological Stage IIIB, C or D (Any T, N1b, N2b, N2c, N3b, or N3c) cutaneous or unknown primary melanoma, with or without primary tumour in situ 4. A minimum of one macroscopic lymph node, defined as: * A palpable node, confirmed by pathology * A non-palpable node, but enlarged per RECIST 1.1 criteria (≥ 15 mm in shortest diameter) and confirmed by pathology * An ultrasound or PET/CT scan positive lymph node of…
Interventions
- ProcedureIndex lymph node resection
The largest lymph node affected with melanoma
- ProcedureTherapeutic lymph node dissection
Removal of all nodes in the melanoma affected lymph node basin
Locations (7)
- Cedars-Sinai Medical CentreLos Angeles, California
- Calvary Mater NewcastleNewcastle, New South Wales
- Melanoma Institute AustraliaWollstonecraft, New South Wales
- Fiona Stanley HospitalMurdoch, Western Australia
- Sunnybrook Health Sciences CentreToronto, Ontario
- San Maria della Misericordia HospitalPerugia