Minimal SN Tumor Burden

NCT01942603 · tracked via the Priya Life Science Germany tracker

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Phase

Observational

Started

2009-07

Last updated

2023-11-28

Condition(s) studied

Cutaneous Melanoma

Study summary

The purpose of this registry is to collect data in order to discover whether melanoma patients with minimal SN tumor burden should undergo a complete lymph node dissection (CLND) or not.

Currently, if a patient has a positive (or metastatic) SN, this patient will be offered a CLND, which is a surgical intervention aiming to remove all lymph nodes from the same nodal basin as the SN. However, if the positive (or metastatic) SN is only minimally involved, some centers and/or countries do not offer a CLND routinely. As a matter of fact, the CLND procedure does not increase survival for patients with a minimal SN tumor burden, but can add prognostic information, potentially useful in the subsequent decision-making process. However, this is a surgical operation for the patient, which might be accompanied by significant side effects. Moreover, only approximately 20% of patients with a metastatic SN have further lymph node metastases in the same basin, which means that about 4 patients out of 5 will not benefit from a CLND. Thus, there is an urgent need to identify which SN positive patients could be safely spared from a CLND. It has been demonstrated that breast cancer patients with minimal SN tumor burden can be safely managed with nodal observation only, without performing a CLND. There is evidence that the same situation exists in melanoma as well, but this needs to be validated and this is why we are conducting this registry.

The results of this registry will be crucial to establish an accepted standard of care (CLND or nodal observation) for melanoma patients with minimal SN tumor burden.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 18 years of age or older * 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 interested basin Exclusion Criteria: * 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 -

Primary outcome measure(s)

Distant Metastasis Free Interval (DMFI) — 5 years after last patient in

Trial sites (22)

Facility	City	Region
U.Z. Leuven - Campus Gasthuisberg	Leuven	Belgium
CHRU de Lille	Lille	France
CHU de Nice - Hopital De L'Archet	Nice	France
Institut Gustave Roussy	Paris	France
Charite - Universitaetsmedizin Berlin - Campus Mitte	Berlin	Germany
Universitaetsklinikum - Essen	Essen	Germany
UniversitaetsMedizin Mannheim	Mannheim	Germany
Istituto Europeo di Oncologia	Milan	Italy
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale	Naples	Italy
Istituto Oncologico Veneto IRCCS - Ospedale Busonera	Padova	Italy
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis	Amsterdam	Netherlands
Erasmus MC Cancer Institute - location Daniel den Hoed	Rotterdam	Netherlands
Maria Sklodowska-Curie Memorial Cancer Centre	Warsaw	Poland
The Institute Of Oncology	Ljubljana	Slovenia
Hospital Clinic Universitari	Barcelona	Spain
Centre Hospitalier Universitaire Vaudois	Lausanne	Switzerland
Royal Bournemouth Hospital	Bournemouth	United Kingdom
Cambridge University Hospital NHS - Addenbrookes Hospital	Cambridge	United Kingdom
Guy's and St Thomas' NHS - St Thomas Hospital	London	United Kingdom
St George's Hospital NHS Trust	London	United Kingdom
Norfolk And Norwich Hospital	Norwich	United Kingdom
St Helens & Knowsley NHS Trust - Whiston Hospital	Prescott	United Kingdom

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01942603 on ClinicalTrials.gov ↗ ← All trials in Germany