Minimal SN Tumor Burden

NCT01942603 | Active Not Recruiting DMC

• 1 other identifier: EORTC-1208-MG
• Study Type: observational
• Target: 296
• Locations: 10 countries
• Sites: 22

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.

Conditions

Cutaneous Melanoma

Keywords

Minimal (SN) tumor burden; Stage III; Patients; Lymphnode Dissections

Outcome Measures

Primary Outcomes (1)

• Distant Metastasis Free Interval (DMFI)

  5 years after last patient in

Secondary Outcomes (5)

• Regional Control Rate (secondary endpoint):

  5 years after last patient in

• Relapse Free Interval (RFI)

  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

• Morbidity: rates of wound infections, lymphedema and neurological damage

  5 years after last patient in

Study Arms (2)

Observation

Complete Lymfnode Dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with minimal SN tumor burden

You may qualify if:

• 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

You may not qualify if:

• 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 -

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (22)

U.Z. Leuven - Campus Gasthuisberg

Leuven, Belgium

Location

CHRU de Lille

Lille, France

Location

CHU de Nice - Hopital De L'Archet

Nice, France

Location

Institut Gustave Roussy

Paris, France

Location

Charite - Universitaetsmedizin Berlin - Campus Mitte

Berlin, Germany

Location

Universitaetsklinikum - Essen

Essen, Germany

Location

UniversitaetsMedizin Mannheim

Mannheim, Germany

Location

Istituto Europeo di Oncologia

Milan, Italy

Location

Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

Napoli, Italy

Location

Istituto Oncologico Veneto IRCCS - Ospedale Busonera

Padua, Italy

Location

The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

Amsterdam, Netherlands

Location

Erasmus MC Cancer Institute - location Daniel den Hoed

Rotterdam, Netherlands

Location

Maria Sklodowska-Curie Memorial Cancer Centre

Warsaw, Poland

Location

The Institute Of Oncology

Ljubljana, Slovenia

Location

Hospital Clinic Universitari

Barcelona, Spain

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Location

Royal Bournemouth Hospital

Bournemouth, United Kingdom

Location

Cambridge University Hospital NHS - Addenbrookes Hospital

Cambridge, United Kingdom

Location

Guy's and St Thomas' NHS - St Thomas Hospital

London, United Kingdom

Location

St George's Hospital NHS Trust

London, United Kingdom

Location

Norfolk And Norwich Hospital

Norwich, United Kingdom

Location

St Helens & Knowsley NHS Trust - Whiston Hospital

Prescott, United Kingdom

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2013
• First Posted: September 16, 2013
• Study Start: July 1, 2009
• Primary Completion: December 1, 2023
• Study Completion (Estimated): December 1, 2031
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

DE (3); SL (1); BE (1); NL (2); PL (1); ES (1); CH (1); GB (6); FR (3); IT (3)