International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer (SENTICOLIII)

July 5, 2024 updated by: Centre Hospitalier Universitaire de Besancon

SENTICOL III is large prospective multicenter international randomized study designed to validate the Sentinel Lymph Node (SLN) mapping technique in early cervical cancer. This "validation study" will compare the outcome of patients with negative SLN (experimental arm) vs patients with negative SLN + Pelvic Lymph Node dissection (PLN)(reference arm).

There will be a "quality assurance" program which will be developed in participating centers with detailed requirements in terms of surgeons' qualifications, pathology qualification, SLN ultrastaging, standardization of the procedure, etc. as well as respect of the "safety algorithm".

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

989

Phase

  • Not Applicable

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
      • Liège, Belgium, 4000
        • CHC MontLégia
  • Brazil
      • Campo Grande, Brazil, 79085-039
        • Barretos Cancer Hospital
      • Rio De Janeiro, Brazil, 3709
        • Brazilian National Cancer Institute
      • São Paulo, Brazil
        • Hospital Israelita Albert Einstein
      • São Paulo, Brazil, 01525-001
        • AC Camargo Cancer Center - Sao Paulo
      • São Paulo, Brazil
        • Hospital Amaral Carvalho de Jau
    • Parana
      • Curitiba, Parana, Brazil
        • Hospital Erasto Gaertner
  • Canada
      • Montréal, Canada, QC H1T 2M4
        • CIUSSS de l'Est-de-I'lle-de-Montreal Hopital Maisonneuve-Rosemont (CAHA)
      • Montréal, Canada
        • CHUM Centre Hospitalier de l'Université de Montréal
      • Québec, Canada
        • CHU Québec (Hôtel Dieu)
      • Regina, Canada
        • Allan Blair Cancer Centre (CASA)
      • Saskatoon, Canada
        • Saskatoon Cancer Centre.(CASS)
      • Sherbrooke, Canada, J1G 1B1
        • CIUSS de l'Estrie - Centre hospitalier universitaire de Sherbrooke - CAGH
      • Vancouver, Canada, BC V5Z 1M9
        • Clinical Research Unit at Vancouver Coastal Health Authority (CAVG)
      • Winnipeg, Canada, R3E 0V9
        • CancerCare Manitoba
  • China
      • Wenzhou, China, 325015
        • The 1st Affiliated Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Cancer Hospital of University of Chinese Academy of Science
  • Czechia
      • Olomouc, Czechia, 779 00
        • University Hospital Olomouc
      • Ostrava-Poruba, Czechia, 708 00
        • University Hospital Ostrava
      • Praha, Czechia, 128 51
        • General University Hospital
      • Praha, Czechia, 180-81
        • University Hospital Bulovka
  • France
      • Amiens, France
        • CHU d'AMIENS
      • Besançon, France, 25000
        • CHU de Besançon
      • Bordeaux, France, 33000
        • Institut Bergonie
      • Bordeaux, France
        • Clinique TIVOLI-DUCOS
      • Caen, France
        • CHU de Caen
      • Caen, France, 14000
        • Center de Lutte Contre le Cancer François Baclesse
      • Clamart, France, 92140
        • Hôpital Antoine Béclère
      • Clermont-Ferrand, France, 63000
        • Centre de Lutte Contre le Cancer Jean PERRIN
      • Clermont-Ferrand, France
        • CHU de Clermont-Ferrand - Hopital d'Estaing
      • Créteil, France, 94000
        • CHI de Créteil
      • Dijon, France, 21079
        • Centre Georges François Leclerc
      • Dijon, France, 21000
        • CHU de Dijon Bourgogne
      • Le Kremlin-Bicêtre, France, 94270
        • Hôpital Bicêtre
      • Lille, France
        • Centre Oscar Lambret
      • Lille, France
        • CHRU de Lille - Hôpital Jeanne de Flandre
      • Limoges, France, 87000
        • CHU de Limoges
      • Lyon, France
        • Groupement Hospitalier Est - Hôpital Femme Mère Enfant
      • Marseille, France
        • Institut Paoli Calmettes
      • Marseille, France
        • Hôpital Saint-Joseph
      • Marseille, France
        • Hôpital de la Conception
      • Montpellier, France, 34000
        • Institut de Cancérologie de Montpellier Val d'Aurelle
      • Mulhouse, France
        • CH de Mulhouse - Hôpital du Hasenrain
      • Nantes, France
        • Institut de Cancérologie de l'Ouest - Centre René Gauducheau
      • Nice, France, 06000
        • Centre de Lutte Contre le Cancer Antoine Lacassagne
      • Paris, France
        • Hopital Lariboisiere
      • Paris, France
        • Hôpital Européen Georges Pompidou
      • Paris, France
        • Hôpital Tenon
      • Paris, France, 75005
        • Institut Curie - Site de Paris
      • Paris, France, 75020
        • Groupe Hospitalier Diaconesses Croix Saint Simon
      • Paris, France
        • Groupe Hospitalier La Pitié Salpêtrière
      • Paris, France
        • Centre Hospitalier Bichat - Claude Bernard
      • Pierre-Bénite, France
        • CH Lyon Sud
      • Poissy, France
        • Hôpital de Poissy-Saint-Germain-en-Laye
      • Poitiers, France
        • CHU de Poitiers - Hôpital de La Milétrie
      • Reims, France, 51100
        • Centre Jean Godinot
      • Reims, France
        • CHU de Reims - Hôpital Robert Debré
      • Rennes, France
        • CHU de Rennes - Hôpital Sud
      • Rouen, France, 76100
        • Clinique Mathilde
      • Rouen, France
        • Centre Henri Becquerel
      • Strasbourg, France
        • Hôpitaux Universitaires de Strasbourg
      • Toulouse, France, 31000
        • Institut universitaire du cancer de Toulouse
      • Vandoeuvre les nancy, France, 54500
        • Institut de Cancerologie de Lorraine
      • Villejuif, France
        • Centre de Lutte Contre le Cancer Gustave Roussy
    • La Réunion
      • Saint-Denis, La Réunion, France, 97400
        • CHU de la réunion
    • Marne-le-Vallée
      • Paris, Marne-le-Vallée, France, 77420
        • Grand Hôpital de l'Est Francilien
  • Germany
      • Berlin, Germany, 13509
        • Vivantes Humboldt-Klinikum
      • Dresden, Germany, 01307
        • Universitatsklinikum Carl Gustav Carus
      • Düsseldorf, Germany, 40225
        • Universitätsklinikum Düsseldorf
      • Düsseldorf, Germany, 40489
        • Florence-Nightingale-Krankenhaus
      • Essen, Germany, 45136
        • Kliniken Essen Mitte, Evang. Huyssens-Stiftung
      • Fürth, Germany, 90766
        • Frauenklinik Fürth
      • Gießen, Germany, 35392
        • Universitätsklinikum Gießen und Marburg - UKGM Giessen
      • Hamburg, Germany, 20426
        • Universitätsklinikum Hamburg-Eppendorf
      • Hanover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Jena, Germany, 07747
        • Universitätsklinikum Jena
      • Karlsruhe, Germany, 76133
        • Stadtisches Klinikum Karlsruhe
      • Kassel, Germany, 34125
        • Klinikum Kassel
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
      • München, Germany, 81336
        • Klinikum der Universität München
      • Münster, Germany, 48149
        • Universitätsklinikum Münster
      • Rostock, Germany, 18059
        • UFK am Klinikum Südstradt Rostock
      • Tübingen, Germany, 72076
        • Universitaätsklinikum Tübingen
      • Ulm, Germany, 89075
        • Universitatsklinikum Ulm
      • Wolfsburg, Germany, 38440
        • Klinikum Wolfsburg
  • India
    • Telangana
      • Hyderabad, Telangana, India, 500034
        • Basavatarakam Indo-American Cancer Hospital & Research Institute
    • West Bengal
      • Kolkata, West Bengal, India, 700026
        • Chittaranjan National Cancer Institute (CNCI)
  • Italy
      • Milano, Italy, 20141
        • Istituto Europe di Oncologia
      • Monza, Italy, 20900
        • Ospedale San Gerardo Monza
  • Japan
      • Saitama, Japan
        • Saitama Medical University International Medical Center
  • Norway
      • Oslo, Norway, 0379
        • Oslo Universitetssykehus HF Radiumhospitalet
  • Slovakia
      • Bratislava, Slovakia, 833 10
        • National Oncology Institute
      • Bratislava, Slovakia, 826 06
        • University Hospital Bratislava
      • Trenčín, Slovakia, 911 01
        • University Hospital Trencin
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic De Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d´Hebron
      • Castelló de la Plana, Spain, 12004
        • Hospital General Universitario de Castellon
      • Donostia, Spain, 20014
        • Hospital Universitario DE Donostia
      • Girona, Spain, 17007
        • Hospital Universitario de Girona Dr. Josep Trueta
      • Girona, Spain, 17007
        • Hopital Clinico Universitario de Valencia
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28040
        • Hospital Clinico Universitario San Carlos
      • Vigo, Spain, 36312
        • Hospital Álvaro Cunqueiro
  • Switzerland
      • Lausanne, Switzerland, 1011
        • CHUV

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

Description

Inclusion Criteria:

I 1. Patient must be ≥ 18 years old, I 2. With squamous or adenocarcinoma or adenosquamous carcinoma of the cervix (proven by biopsy or cone biopsy), I 3. Stage Ia1 with lymphovascular emboli, Ia2, Ib1 IIa1, Ib2 (clinical stage) of the 2018 FIGO classification (see appendix 1), I 4. Maximum diameter ≤ 40 mm by clinical examination and/or magnetic resonance imaging (MRI), I 5. No suspicious node on pelvic MRI with an exploration up to the left renal vein (according to RECIST 1.1), I 6. ECOG performance status 0-2 (see appendix 2), I 7. Signed informed consent and ability to comply with follow-up, I 8. French subjects: in France, a subject will be eligible for inclusion in this study only if either affiliated to, or a beneficiary of, a social security category.

Exclusion Criteria:

E 1. Pregnancy, E 2. Previous pelvic or abdominal cancer, E 3. Previous chemotherapy and/or radiation therapy for the cervical cancer (previous brachytherapy is accepted), E 4. Proven allergy to blue dye, isotope or indocyanine green (ICG) E 5. Other malignancy within the last 5 years except for treated cancer free of disease and treatment, E 6. Patients with synchronous cancer

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SLN biopsy only
Sentinel lymph node (SLN) biopsy only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.
Procedure: SLN biopsy only
In experimental arm, SLN dissection only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.
Active Comparator: SLN biopsy + PLN dissection
SLN biopsy + full pelvic lymph node dissection (PLN) will be performed. The radical hysterectomy or trachelectomy will be done.
Procedure: SLN biopsy + PLN dissection
In active comparator arm, SLN dissection + full lymphadenectomy will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free Survival (DFS)
Time Frame: Year 3

Composite outcome: the time interval between randomization and recurrence (local/distant) or second cancer or death (all causes), whichever occurs first.

This time interval will be analysed concomitantly with HR-QoL scores as a composite outcome.
Year 3
Health-related quality of life (HR-QoL)
Time Frame: Year 3

Composite outcome: significant deterioration will specifically be assessed through 3 targeted dimensions (pain score, global health score and physical functioning scores) in EORTC QLQ-C30 and QLQ-CX24 questionnaires.

These scores will be analysed concomitantly with DFS as a composite outcome.
Year 3

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Besancon

Collaborators

European Network of Gynaecological Oncological Trial Groups (ENGOT)
ARCAGY/ GINECO GROUP

Investigators

  • Principal Investigator: Fabrice Lecuru, MD PhD, Institut Curie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

May 3, 2018

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

December 15, 2017

First Submitted That Met QC Criteria

December 21, 2017

First Posted (Actual)

December 29, 2017

Study Record Updates

Last Update Posted (Actual)

July 8, 2024

Last Update Submitted That Met QC Criteria

July 5, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N/2016/72
  • ENGOT-Cx4 (Other Identifier: ENGOT)
  • GINECO-CE106 (Other Identifier: GINECO)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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