Clinical trial NCT01942603: Minimal SN Tumor Burden
Official title: Minitub: Prospective Registry of Sentinel Node (SN) Positive Melanoma Patients With Minimal SN Tumor Burden Who Undergo Completion Lymph Node Dissection (CLND) or Nodal Observation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cutaneous Melanoma
Keywords: Minimal (SN) tumor burden
Stage III
Patients
Lymphnode Dissections
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2013-09-16
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with minimal SN tumor burden

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.


Eligibility criteria: 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 outcomes:
measure: Distant Metastasis Free Interval (DMFI)
timeFrame: 5 years after last patient in
Secondary outcomes:
measure: Regional Control Rate (secondary endpoint):
timeFrame: 5 years after last patient in
measure: Relapse Free Interval (RFI)
timeFrame: 5 years after last patient in
measure: Melanoma Specific Survival (MSS)
timeFrame: 5 years after last patient in
measure: Overall Survival (OS)
timeFrame: 5 years after last patient in
measure: Morbidity: rates of wound infections, lymphedema and neurological damage
timeFrame: 5 years after last patient in
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: U.Z. Leuven - Campus Gasthuisberg
city: Lille
country: France
facility: CHRU de Lille
city: Nice
country: France
facility: CHU de Nice - Hopital De L'Archet
city: Paris
country: France
facility: Institut Gustave Roussy
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin - Campus Mitte
city: Essen
country: Germany
facility: Universitaetsklinikum - Essen
city: Mannheim
country: Germany
facility: UniversitaetsMedizin Mannheim
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS - Ospedale Busonera
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus MC Cancer Institute - location Daniel den Hoed
city: Warsaw
country: Poland
facility: Maria Sklodowska-Curie Memorial Cancer Centre
city: Ljubljana
country: Slovenia
facility: The Institute Of Oncology
city: Barcelona
country: Spain
facility: Hospital Clinic Universitari
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospital NHS - Addenbrookes Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS - St Thomas Hospital
city: London
country: United Kingdom
facility: St George's Hospital NHS Trust
city: Norwich
country: United Kingdom
facility: Norfolk And Norwich Hospital
city: Prescott
country: United Kingdom
facility: St Helens & Knowsley NHS Trust - Whiston Hospital
Study officials:
References: