Minimal SN Tumor Burden

Cutaneous Melanoma Clinical Trial

— Minitub  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01942603
• Other study ID #: EORTC-1208-MG
• Status: Active, not recruiting
• Start date: July 2009
• Est. completion date: December 2031

Study information

• Verified date: November 2023
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 296
• Est. completion date: December 2031
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Cutaneous Melanoma
• Melanoma

Locations

Country	Name	City	State
Belgium	U.Z. Leuven - Campus Gasthuisberg	Leuven
France	CHRU de Lille	Lille
France	CHU de Nice - Hopital De L'Archet	Nice
France	Institut Gustave Roussy	Paris
Germany	Charite - Universitaetsmedizin Berlin - Campus Mitte	Berlin
Germany	Universitaetsklinikum - Essen	Essen
Germany	UniversitaetsMedizin Mannheim	Mannheim
Italy	Istituto Europeo di Oncologia	Milan
Italy	Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale	Napoli
Italy	Istituto Oncologico Veneto IRCCS - Ospedale Busonera	Padova
Netherlands	The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis	Amsterdam
Netherlands	Erasmus MC Cancer Institute - location Daniel den Hoed	Rotterdam
Poland	Maria Sklodowska-Curie Memorial Cancer Centre	Warsaw
Slovenia	The Institute Of Oncology	Ljubljana
Spain	Hospital Clinic Universitari	Barcelona
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Netherlands,  Poland,  Slovenia,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distant Metastasis Free Interval (DMFI)		5 years after last patient in
Secondary	Regional Control Rate (secondary endpoint):		5 years after last patient in
Secondary	Relapse Free Interval (RFI)		5 years after last patient in
Secondary	Melanoma Specific Survival (MSS)		5 years after last patient in
Secondary	Overall Survival (OS)		5 years after last patient in
Secondary	Morbidity: rates of wound infections, lymphedema and neurological damage		5 years after last patient in