Publication date: Jun 30, 2025
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.
| Concepts | Keywords |
|---|---|
| Australia | Adverse events |
| Breastfeeding | Healthcare economics |
| Cancer | Neoadjuvant |
| Daily | Non-inferiority |
| Randomized | Quality of life |
| Randomised controlled trial | |
| Surgical morbidity |
Semantics
| Type | Source | Name |
|---|---|---|
| disease | MESH | Melanoma |
| pathway | KEGG | Melanoma |
| disease | MESH | recurrence |
| disease | MESH | complications |
| disease | MESH | metastases |
| drug | DRUGBANK | Nivolumab |
| drug | DRUGBANK | Pembrolizumab |
| drug | DRUGBANK | Cemiplimab |
| drug | DRUGBANK | Ipilimumab |
| disease | MESH | contraindication |
| disease | MESH | malignancies |
| disease | MESH | Basal cell carcinoma |
| pathway | KEGG | Basal cell carcinoma |
| disease | MESH | Carcinoma in situ |
| disease | MESH | breast carcinoma |
| disease | MESH | cervical cancer |
| disease | MESH | Prostatic intraepithelial neoplasia |
| disease | MESH | hyperplasia |
| disease | MESH | autoimmune disease |
| drug | DRUGBANK | Prednisone |
| disease | MESH | pituitary insufficiency |
| disease | MESH | Hepatitis B |
| pathway | KEGG | Hepatitis B |
| drug | DRUGBANK | Hepatitis B Vaccine (Recombinant) |
| disease | MESH | infection |
| disease | MESH | Hepatitis C |
| pathway | KEGG | Hepatitis C |
| disease | MESH | morbidity |
Original Article
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