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

March 26, 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

988

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 Contact

Study Contact Backup

Study Locations

  • Brazil
      • Campo Grande, Brazil, 79085-039
        • Recruiting
        • Barretos Cancer Hospital
        • Principal Investigator:
          • Ricardo REIS
      • Rio De Janeiro, Brazil, 3709
        • Recruiting
        • Brazilian National Cancer Institute
        • Principal Investigator:
          • Gustavo GUITMANN
      • São Paulo, Brazil
        • Recruiting
        • Hospital Israelita Albert Einstein
        • Principal Investigator:
          • Renato MORETTI MARQUES
      • São Paulo, Brazil, 01525-001
        • Recruiting
        • AC Camargo Cancer Center - Sao Paulo
        • Principal Investigator:
          • Glauco BAIOCCHI
      • São Paulo, Brazil
        • Active, not recruiting
        • Hospital Amaral Carvalho de Jaù
    • Parana
      • Curitiba, Parana, Brazil
        • Recruiting
        • Hospital Erasto Gaertner
        • Principal Investigator:
          • Audrey TIEKO TSUNODA
  • Canada
      • Montréal, Canada, QC H1T 2M4
        • Recruiting
        • CIUSSS de l'Est-de-I'lle-de-Montreal Hopital Maisonneuve-Rosemont (CAHA)
        • Principal Investigator:
          • Lara DE GUERKE
      • Montréal, Canada
        • Recruiting
        • CHUM Centre Hospitalier de l'Université de Montréal
        • Principal Investigator:
          • Vanessa SAMOUËLIAN, MD
      • Québec, Canada
        • Recruiting
        • CHU Québec (Hôtel Dieu)
        • Principal Investigator:
          • Marie PLANTE, MD
      • Regina, Canada
        • Recruiting
        • Allan Blair Cancer Centre (CASA)
        • Principal Investigator:
          • Shaina Joojyun LEE
      • Saskatoon, Canada
        • Recruiting
        • Saskatoon Cancer Centre.(CASS)
        • Principal Investigator:
          • Jennifer BROWN BRODERICK
      • Sherbrooke, Canada, J1G 1B1
        • Recruiting
        • CIUSS de l'Estrie - Centre hospitalier universitaire de Sherbrooke - CAGH
        • Principal Investigator:
          • Mathieu VIAU
      • Vancouver, Canada, BC V5Z 1M9
        • Active, not recruiting
        • Clinical Research Unit at Vancouver Coastal Health Authority (CAVG)
  • China
      • Wenzhou, China, 325015
        • Recruiting
        • The 1st Affiliated Hospital
        • Principal Investigator:
          • Yan XIAOJIAN
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Cancer Hospital of University of Chinese Academy of Science
        • Contact:
          • Wen Qiang, MD
        • Contact:
          • Qiang Wen, MD
  • Czechia
      • Olomouc, Czechia, 779 00
        • Recruiting
        • University Hospital Olomouc
        • Principal Investigator:
          • Radovan PILKA
      • Ostrava-Poruba, Czechia, 708 00
        • Recruiting
        • University Hospital Ostrava
        • Principal Investigator:
          • Jaroslav KLAT
      • Praha, Czechia, 128 51
        • Recruiting
        • General University Hospital
        • Principal Investigator:
          • David CIBULA
      • Praha, Czechia, 180-81
        • Recruiting
        • University Hospital Bulovka
        • Principal Investigator:
          • Michal ZIKAN
  • France
      • Amiens, France
        • Recruiting
        • CHU d'Amiens
        • Contact:
          • Fabrice Sergent, MD
      • Besançon, France, 25000
        • Recruiting
        • CHU de Besançon
        • Contact:
          • Rajeev Ramanah, MD, PhD
      • Bordeaux, France, 33000
        • Recruiting
        • Institut Bergonié
        • Contact:
          • Frederic Guyon, MD
      • Bordeaux, France
        • Recruiting
        • Clinique Tivoli-Ducos
        • Contact:
          • Sophie Richard, MD
      • Caen, France
        • Recruiting
        • CHU de Caen
        • Contact:
          • Raffaele Fauvet, MD PhD
      • Caen, France, 14000
        • Recruiting
        • Center de Lutte Contre le Cancer François Baclesse
        • Contact:
          • Sandrine Martin-Françoise, MD
      • Clamart, France, 92140
        • Recruiting
        • Hopital Antoine Beclere
        • Contact:
          • Xavier Deffieux, MD PhD
      • Clermont-Ferrand, France, 63000
        • Recruiting
        • Centre de Lutte Contre le Cancer Jean PERRIN
        • Contact:
          • Caroline Cornou, MD
      • Clermont-Ferrand, France
        • Recruiting
        • CHU de Clermont-Ferrand - Hôpital d'Estaing
        • Contact:
          • Nicolas Bourdel, MD
      • Créteil, France, 94000
        • Recruiting
        • CHI de Créteil
        • Principal Investigator:
          • Jennifer UZAN, MD
      • Dijon, France, 21079
        • Recruiting
        • Centre Georges François Leclerc
        • Principal Investigator:
          • Hélène COSTAZ, MD
      • Dijon, France, 21000
        • Recruiting
        • CHU de Dijon Bourgogne
        • Contact:
          • Serge Douvier, MD PhD
      • Le Kremlin-Bicêtre, France, 94270
        • Recruiting
        • Hôpital Bicêtre
        • Contact:
          • Perrine Capmas, MD
      • Lille, France
        • Recruiting
        • Centre Oscar Lambret
        • Principal Investigator:
          • Fabrice NARDUCCI, MD
      • Lille, France
        • Recruiting
        • CHRU de Lille - Hôpital Jeanne de Flandre
        • Principal Investigator:
          • Jérôme PHALIPPOU, MD
      • Limoges, France, 87000
        • Recruiting
        • Chu de Limoges
        • Contact:
          • Tristan Gauthier, MD PhD
      • Lyon, France
        • Recruiting
        • Groupement Hospitalier Est - Hôpital Femme Mère Enfant
        • Principal Investigator:
          • Gautier CHENE, MD PhD
      • Marseille, France
        • Recruiting
        • Hopital de la Conception
        • Principal Investigator:
          • Patrice CROCHET, MD
      • Marseille, France
        • Recruiting
        • Institut Paoli Calmettes
        • Contact:
          • Eric Lambaudie, MD
      • Marseille, France
        • Recruiting
        • Hôpital Saint-Joseph
        • Contact:
          • Elisabeth Chereau-Ewald, MD PhD
      • Montpellier, France, 34000
        • Recruiting
        • Institut de Cancérologie de Montpellier Val d'Aurelle
        • Contact:
          • Pierre-Emmanuel Colombo, MD
      • Mulhouse, France
        • Recruiting
        • CH de Mulhouse - Hôpital du Hasenrain
        • Contact:
          • Ramzi Kacem, MD
      • Nantes, France
        • Recruiting
        • Institut de Cancérologie de l'Ouest - Centre René Gauducheau
        • Contact:
          • Cecile Loaëc, MD
        • Principal Investigator:
          • Cecile Loaëc, MD
      • Nice, France, 06000
        • Recruiting
        • Centre de Lutte Contre le Cancer Antoine Lacassagne
        • Contact:
          • Yves Fouché, MD PhD
      • Paris, France
        • Recruiting
        • Hôpital Européen Georges Pompidou
        • Contact:
          • Anne-Sophie Bats, MD
      • Paris, France, 75020
        • Recruiting
        • Groupe Hospitalier Diaconesses Croix Saint Simon
        • Contact:
          • Marcos Ballester, MD, PhD
      • Paris, France
        • Recruiting
        • Hôpital Tenon
        • Contact:
          • Sofiane Bendifallah, MD
      • Paris, France
        • Recruiting
        • Hôpital Lariboisière
        • Principal Investigator:
          • Cyrille HUCHON, MD PhD
      • Paris, France
        • Recruiting
        • Centre Hospitalier Bichat - Claude Bernard
        • Contact:
          • Martin Koskas, MD
      • Paris, France
        • Recruiting
        • Groupe Hospitalier la Pitié Salpêtrière
        • Contact:
          • Jérémie Belghiti, MD
      • Paris, France, 75005
        • Recruiting
        • Institut Curie - Site de Paris
        • Contact:
          • Virginie Fourchotte, MD
      • Pierre-Bénite, France
        • Recruiting
        • CH Lyon sud
        • Contact:
          • François Golfier, MD PhD
      • Poissy, France
        • Recruiting
        • Hôpital de Poissy-Saint-Germain-en-Laye
        • Principal Investigator:
          • François MARGUERITTE, MD
      • Poitiers, France
        • Recruiting
        • CHU de Poitiers - Hôpital de la Milétrie
        • Principal Investigator:
          • Amélie CHARVERIAT, MD
      • Reims, France, 51100
      • Reims, France
        • Recruiting
        • CHU de Reims - Hôpital Robert Debré
        • Contact:
          • Olivier Graesslin, MD PhD
      • Rennes, France
        • Recruiting
        • CHU de Rennes - Hôpital Sud
        • Contact:
          • Vincent Lavoue, MD PhD
      • Rouen, France, 76100
        • Recruiting
        • Clinique Mathilde
        • Principal Investigator:
          • Marc BARON, MD
      • Rouen, France
        • Recruiting
        • Centre Henri Becquerel
        • Principal Investigator:
          • Agathe CROUZET, MD
      • Strasbourg, France
        • Recruiting
        • Hôpitaux Universitaires de Strasbourg
        • Principal Investigator:
          • Chérif AKLADIOS, MD PhD
      • Toulouse, France, 31000
        • Recruiting
        • Institut Universitaire du Cancer de Toulouse
        • Contact:
          • Gwenael Ferron, MD
      • Vandoeuvre les nancy, France, 54500
        • Recruiting
        • Institut de Cancérologie de Lorraine
        • Contact:
          • Frédéric Marchal, MD PhD
      • Villejuif, France
        • Recruiting
        • Centre de Lutte Contre le Cancer Gustave Roussy
        • Contact:
          • Sébastien Gouy, MD
    • La Réunion
      • Saint-Denis, La Réunion, France, 97400
        • Recruiting
        • CHU de la Réunion
        • Contact:
          • Anca Paula Birsan Frances, MD
    • Marne-le-Vallée
      • Paris, Marne-le-Vallée, France, 77420
        • Recruiting
        • Grand Hôpital de l'Est Francilien
        • Principal Investigator:
          • Estelle WAFO, MD
  • Germany
      • Berlin, Germany, 13509
        • Active, not recruiting
        • Vivantes Humboldt-Klinikum
      • Dresden, Germany, 01307
        • Recruiting
        • Universitätsklinikum Carl Gustav Carus
        • Principal Investigator:
          • Pauline WIMBERGER
      • Düsseldorf, Germany, 40225
        • Recruiting
        • Universitätsklinikum Düsseldorf
        • Principal Investigator:
          • Tanja Fehm
      • Düsseldorf, Germany, 40489
        • Recruiting
        • Florence-Nightingale-Krankenhaus
        • Principal Investigator:
          • Björn LAMPE
      • Essen, Germany, 45136
        • Recruiting
        • Kliniken Essen Mitte, Evang. Huyssens-Stiftung
        • Principal Investigator:
          • Philipp HARTER
      • Fürth, Germany, 90766
        • Active, not recruiting
        • Frauenklinik Fürth
      • Gießen, Germany, 35392
        • Active, not recruiting
        • Universitätsklinikum Gießen und Marburg - UKGM Giessen
      • Hamburg, Germany, 20426
        • Recruiting
        • Universitätsklinikum Hamburg-Eppendorf
        • Principal Investigator:
          • Barbara SCHMALFELDT
      • Hanover, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover
        • Principal Investigator:
          • Ellen CLAUS
      • Jena, Germany, 07747
        • Active, not recruiting
        • Universitatsklinikum Jena
      • Karlsruhe, Germany, 76133
        • Active, not recruiting
        • Städtisches Klinikum Karlsruhe
      • Kassel, Germany, 34125
        • Active, not recruiting
        • Klinikum Kassel
      • Lübeck, Germany, 23538
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
        • Principal Investigator:
          • Lars HANKER
      • München, Germany, 81336
        • Recruiting
        • Klinikum der Universität München
        • Principal Investigator:
          • Alexander BURGES
      • Münster, Germany, 48149
        • Not yet recruiting
        • Universitatsklinikum Munster
        • Principal Investigator:
          • Ralf WITTELER
      • Rostock, Germany, 18059
        • Recruiting
        • UFK am Klinikum Südstradt Rostock
        • Principal Investigator:
          • Toralf REIMER
      • Tübingen, Germany, 72076
        • Active, not recruiting
        • Universitaätsklinikum Tübingen
      • Ulm, Germany, 89075
        • Active, not recruiting
        • Universitätsklinikum Ulm
      • Wolfsburg, Germany, 38440
        • Recruiting
        • Klinikum Wolfsburg
        • Principal Investigator:
          • Mignon-Denise KEYVER-PAIK
  • India
    • Telangana
      • Hyderabad, Telangana, India, 500034
        • Recruiting
        • Basavatarakam Indo-American Cancer Hospital & Research Institute
        • Principal Investigator:
          • Raju KVVN
    • West Bengal
      • Kolkata, West Bengal, India, 700026
        • Recruiting
        • Chittaranjan National Cancer Institute (CNCI)
        • Principal Investigator:
          • Asima MUKHOPADHYAY
  • Italy
      • Milano, Italy, 20141
        • Recruiting
        • Istituto Europe di Oncologia
        • Principal Investigator:
          • Vanna ZANAGNOLO
      • Monza, Italy, 20900
        • Recruiting
        • Ospedale San Gerardo Monza
        • Contact:
          • MD
        • Principal Investigator:
          • Fabio LANDONI
  • Japan
      • Saitama, Japan
        • Recruiting
        • Saitama Medical University International Medical Center
        • Contact:
        • Principal Investigator:
          • Akira Yabuno, MD
  • Norway
      • Oslo, Norway, 0379
        • Recruiting
        • Oslo Universitetssykehus HF Radiumhospitalet
        • Principal Investigator:
          • Ane Gerda Zahl ERIKSSON
  • Slovakia
      • Bratislava, Slovakia, 826 06
        • Recruiting
        • University Hospital Bratislava
        • Principal Investigator:
          • Mikulas REDECHA
      • Bratislava, Slovakia, 833 10
        • Recruiting
        • National Oncology Institute
        • Principal Investigator:
          • Milan KRKOSKA
      • Trenčín, Slovakia, 911 01
        • Recruiting
        • University Hospital Trencin
        • Principal Investigator:
          • Peter KASCAK
  • Spain
      • Barcelona, Spain, 08036
        • Active, not recruiting
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08035
        • Active, not recruiting
        • Hospital Universitario Vall d´Hebron
      • Castelló de la Plana, Spain, 12004
        • Recruiting
        • Hospital General Universitario de Castellón
        • Principal Investigator:
          • Jose Antonio LLUECA ABELLA
      • Donostia, Spain, 20014
        • Active, not recruiting
        • Hospital Universitario de Donostia
      • Girona, Spain, 17007
        • Active, not recruiting
        • Hopital Clinico Universitario de Valencia
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Principal Investigator:
          • Alvaro TEJERIZO
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Principal Investigator:
          • Ignacio ZAPARDIEL GUTIERREZ
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clínico Universitario San Carlos
        • Principal Investigator:
          • Antonio CASADO HERRAEZ
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Ramón y Caja
        • Principal Investigator:
          • Enrique MORATALLA BARTOLOME
      • Vigo, Spain, 36312
        • Recruiting
        • Hospital Alvaro Cunqueiro
        • Principal Investigator:
          • Gloria CORDEIRO VIDAL
  • Switzerland
      • Lausanne, Switzerland, 1011
        • Recruiting
        • CHUV
        • Principal Investigator:
          • Patrice MATHEVET

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)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

February 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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