Minimal SN Tumor Burden

Active, not recruiting

• Conditions: Cutaneous Melanoma

• Registration Number: NCT01942603
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2013-09-11
• Study First Submitted QC: 2013-09-13
• Study First Posted: 2013-09-16
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28
• Primary Completion: 2023-12
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 296

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 -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distant Metastasis Free Interval (DMFI)	5 years after last patient in

Secondary Outcome Measures

Name	Time	Method
Regional Control Rate (secondary endpoint):	5 years after last patient in
Relapse Free Interval (RFI)	5 years after last patient in
Morbidity: rates of wound infections, lymphedema and neurological damage	5 years after last patient in
Melanoma Specific Survival (MSS)	5 years after last patient in
Overall Survival (OS)	5 years after last patient in

Trial Locations

Locations (22)

Norfolk And Norwich Hospital; 🇬🇧 Norwich, United Kingdom

Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale; 🇮🇹 Napoli, Italy

Erasmus MC Cancer Institute - location Daniel den Hoed; 🇳🇱 Rotterdam, Netherlands

U.Z. Leuven - Campus Gasthuisberg; 🇧🇪 Leuven, Belgium

CHRU de Lille; 🇫🇷 Lille, France

Institut Gustave Roussy; 🇫🇷 Paris, France

CHU de Nice - Hopital De L'Archet; 🇫🇷 Nice, France

Charite - Universitaetsmedizin Berlin - Campus Mitte; 🇩🇪 Berlin, Germany

Universitaetsklinikum - Essen; 🇩🇪 Essen, Germany

Istituto Europeo di Oncologia; 🇮🇹 Milan, Italy

UniversitaetsMedizin Mannheim; 🇩🇪 Mannheim, Germany

Istituto Oncologico Veneto IRCCS - Ospedale Busonera; 🇮🇹 Padova, Italy

The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis; 🇳🇱 Amsterdam, Netherlands

Maria Sklodowska-Curie Memorial Cancer Centre; 🇵🇱 Warsaw, Poland

The Institute Of Oncology; 🇸🇮 Ljubljana, Slovenia

Hospital Clinic Universitari; 🇪🇸 Barcelona, Spain

Royal Bournemouth Hospital; 🇬🇧 Bournemouth, United Kingdom

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

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

St Helens & Knowsley NHS Trust - Whiston Hospital; 🇬🇧 Prescott, United Kingdom