Minimal SN Tumor Burden (Minitub)

November 27, 2023 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

296

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with minimal SN tumor burden

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Observation
Complete Lymfnode Dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Distant Metastasis Free Interval (DMFI)
Time Frame: 5 years after last patient in
5 years after last patient in

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Principal Investigator: Alexander van Akkooi, MD, PhD, The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

September 11, 2013

First Submitted That Met QC Criteria

September 13, 2013

First Posted (Estimated)

September 16, 2013

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-1208-MG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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