Melanoma Skin Cancer
Conditions
Interventions
None listed
Sponsors
European Organisation for Research in Treatment of Cancer (EORTC)
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Histological evidence of primary cutaneous melanoma * Metastases solely confined within the SN: * in the sub-capsular space (with no parenchymal infiltration) and with a maximum diameter of the largest metastasis not greater than 0.4 mm or * regardless of the site, any sub-micrometastasis with a maximum diameter not greater than 0.1 mm If there is more than 1 metastatic SN, the patient will be still eligible provided that all involved SN have minimal tumor burden, regardless of the amount of positive SNs and the basin of interest * Absence of clinically apparent metastatic disease at the time of or before undergoing a SN procedure * Age >=18 years * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial * Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
Exclusion criteria
Exclusion criteria: * No previous SN procedure for locally recurrent melanoma or uncertain malignant disease, such as atypical Spitz tumor/naevi * No history of a previous melanoma (preceding the melanoma which prompted the SN biopsy) * No history of any other malignancy within the past 5 years, except for non-melanoma skin cancer (Basal Cell Carcinomas or Squamous Cell Carcinomas) and in situ cervical cancer * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Distant Metastasis Free Interval (DMFI), defined as the time from SN positive biopsy until distant metastasis or death due to melanoma, whichever comes first. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Regional Control Rate (secondary endpoint): * Regional Metastasis Free Interval (RMFI): time from SN positive biopsy (date of surgical procedure) until regional relapse, on the same basin as the SN was previously removed. * Regional Control Rate (RCR): rate of lymph node relapse (date of delayed CLND) in the same basin as the SN was previously removed. Regional relapse does not include any local or in-transit recurrences. * Relapse Free Interval (RFI), defined as the time from SN positive biopsy until first relapse - regional or distant metastasis - or death due to melanoma. * Melanoma Specific Survival (MSS), defined as the time from SN positive biopsy until death due to melanoma. * Overall Survival (OS), defined as the time from SN positive biopsy until death due to any cause. | — |
Countries
Netherlands
Outcome results
None listed