International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer

Last updated: July 5, 2024
Sponsor: Centre Hospitalier Universitaire de Besancon
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cervical Cancer

Vaginal Cancer

Pelvic Cancer

Treatment

SLN biopsy only

SLN biopsy + PLN dissection

Clinical Study ID

NCT03386734
N/2016/72
ENGOT-Cx4
GINECO-CE106
  • Ages > 18
  • Female

Study Summary

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".

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 989
Treatment Group(s): 2
Primary Treatment: SLN biopsy only
Phase:
Study Start date:
May 03, 2018
Estimated Completion Date:
May 31, 2029

Connect with a study center

  • CHC MontLégia

    Liège, 4000
    Belgium

    Site Not Available

  • Hospital Erasto Gaertner

    Curitiba, Parana
    Brazil

    Site Not Available

  • Barretos Cancer Hospital

    Campo Grande, 79085-039
    Brazil

    Site Not Available

  • Hospital de Armor de Barretos

    Campo Grande, 79085-039
    Brazil

    Active - Recruiting

  • Brazilian National Cancer Institute

    Rio De Janeiro, 3709
    Brazil

    Site Not Available

  • AC Camargo Cancer Center - Sao Paulo

    São Paulo, 01525-001
    Brazil

    Site Not Available

  • Hospital Amaral Carvalho de Jaù

    São Paulo,
    Brazil

    Site Not Available

  • Hospital Israelita Albert Einstein

    São Paulo,
    Brazil

    Site Not Available

  • CHUM Centre Hospitalier de l'Université de Montréal

    Montréal,
    Canada

    Site Not Available

  • CIUSSS de l'Est-de-I'lle-de-Montreal Hopital Maisonneuve-Rosemont (CAHA)

    Montréal, QC H1T 2M4
    Canada

    Site Not Available

  • CHU Québec (Hôtel Dieu)

    Québec,
    Canada

    Site Not Available

  • Allan Blair Cancer Centre (CASA)

    Regina,
    Canada

    Site Not Available

  • Saskatoon Cancer Centre.(CASS)

    Saskatoon,
    Canada

    Site Not Available

  • CIUSS de l'Estrie - Centre hospitalier universitaire de Sherbrooke - CAGH

    Sherbrooke, J1G 1B1
    Canada

    Site Not Available

  • Clinical Research Unit at Vancouver Coastal Health Authority (CAVG)

    Vancouver, BC V5Z 1M9
    Canada

    Site Not Available

  • CancerCare Manitoba

    Winnipeg, R3E 0V9
    Canada

    Site Not Available

  • Cancer Hospital of University of Chinese Academy of Science

    Hangzhou, Zhejiang 310022
    China

    Site Not Available

  • The 1st Affiliated Hospital

    Wenzhou, 325015
    China

    Site Not Available

  • University Hospital Olomouc

    Olomouc, 779 00
    Czechia

    Site Not Available

  • University Hospital Ostrava

    Ostrava-Poruba, 708 00
    Czechia

    Site Not Available

  • General University Hospital

    Praha, 128 51
    Czechia

    Site Not Available

  • University Hospital Bulovka

    Praha, 180-81
    Czechia

    Site Not Available

  • CHU de la Réunion

    Saint-Denis, La Réunion 97400
    France

    Site Not Available

  • Grand Hôpital de l'Est Francilien

    Paris, Marne-le-Vallée 77420
    France

    Site Not Available

  • CHU d'Amiens

    Amiens,
    France

    Site Not Available

  • Hôpital Henri Duffaut

    Avignon,
    France

    Site Not Available

  • CHU de Besançon

    Besançon, 25000
    France

    Site Not Available

  • Clinique Tivoli-Ducos

    Bordeaux,
    France

    Site Not Available

  • Institut Bergonié

    Bordeaux, 33000
    France

    Site Not Available

  • CHU de Caen

    Caen,
    France

    Site Not Available

  • Center de Lutte Contre le Cancer François Baclesse

    Caen, 14000
    France

    Site Not Available

  • Hôpital Antoine Béclère

    Clamart, 92140
    France

    Site Not Available

  • CHU de Clermont-Ferrand - Hôpital d'Estaing

    Clermont-Ferrand,
    France

    Site Not Available

  • Centre de Lutte Contre le Cancer Jean Perrin

    Clermont-Ferrand, 63000
    France

    Site Not Available

  • CHI de Créteil

    Créteil, 94000
    France

    Site Not Available

  • CHU de Dijon Bourgogne

    Dijon, 21000
    France

    Site Not Available

  • Centre Georges François Leclerc

    Dijon, 21079
    France

    Site Not Available

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270
    France

    Site Not Available

  • CHRU de Lille - Hôpital Jeanne de Flandre

    Lille,
    France

    Site Not Available

  • Centre Oscar Lambret

    Lille,
    France

    Site Not Available

  • CHU de Limoges

    Limoges, 87000
    France

    Site Not Available

  • Groupement Hospitalier Est - Hôpital Femme Mère Enfant

    Lyon,
    France

    Site Not Available

  • Grand Hôpital de l'Est Francilien

    Marne La Vallée,
    France

    Site Not Available

  • Grand Hôpital de l'Est Francilien

    Marne-la-Vallée,
    France

    Site Not Available

  • Hôpital Saint-Joseph

    Marseille,
    France

    Site Not Available

  • Hôpital de la Conception

    Marseille,
    France

    Site Not Available

  • Institut Paoli Calmettes

    Marseille,
    France

    Site Not Available

  • Institut de Cancérologie de Montpellier Val d'Aurelle

    Montpellier, 34000
    France

    Site Not Available

  • CH de Mulhouse - Hôpital du Hasenrain

    Mulhouse,
    France

    Site Not Available

  • Institut de Cancérologie de l'Ouest - Centre René Gauducheau

    Nantes,
    France

    Site Not Available

  • Centre de Lutte Contre le Cancer Antoine Lacassagne

    Nice, 06000
    France

    Site Not Available

  • Centre Hospitalier Bichat - Claude Bernard

    Paris,
    France

    Site Not Available

  • Groupe Hospitalier Diaconesses Croix Saint Simon

    Paris, 75020
    France

    Site Not Available

  • Groupe Hospitalier la Pitié Salpêtrière

    Paris,
    France

    Site Not Available

  • Hôpital Européen Georges Pompidou

    Paris,
    France

    Site Not Available

  • Hôpital Lariboisière

    Paris,
    France

    Site Not Available

  • Hôpital Tenon

    Paris,
    France

    Site Not Available

  • Institut Curie

    Paris, 75005
    France

    Active - Recruiting

  • Institut Curie - site de Paris

    Paris, 75005
    France

    Site Not Available

  • CH Lyon Sud

    Pierre-Bénite,
    France

    Site Not Available

  • Hôpital de Poissy-Saint-Germain-en-Laye

    Poissy,
    France

    Site Not Available

  • CHU de Poitiers - Hôpital de la Milétrie

    Poitiers,
    France

    Site Not Available

  • CHU de Reims - Hôpital Robert Debré

    Reims,
    France

    Site Not Available

  • Centre Jean Godinot

    Reims, 51100
    France

    Site Not Available

  • CHU de Rennes - Hôpital Sud

    Rennes,
    France

    Site Not Available

  • Centre Henri Becquerel

    Rouen,
    France

    Site Not Available

  • Clinique Mathilde

    Rouen, 76100
    France

    Site Not Available

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg,
    France

    Site Not Available

  • Institut Universitaire du Cancer de Toulouse

    Toulouse, 31000
    France

    Site Not Available

  • Institut de Cancérologie de Lorraine

    Vandoeuvre les nancy, 54500
    France

    Site Not Available

  • Centre de Lutte Contre le Cancer Gustave Roussy

    Villejuif,
    France

    Site Not Available

  • Vivantes Humboldt-Klinikum

    Berlin, 13509
    Germany

    Site Not Available

  • Universitätsklinikum Carl Gustav Carus

    Dresden, 01307
    Germany

    Site Not Available

  • Florence-Nightingale-Krankenhaus

    Düsseldorf, 40489
    Germany

    Site Not Available

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225
    Germany

    Site Not Available

  • Kliniken Essen Mitte, Evang. Huyssens-Stiftung

    Essen, 45136
    Germany

    Site Not Available

  • Frauenklinik Fürth

    Fürth, 90766
    Germany

    Site Not Available

  • Universitätsklinikum Gießen und Marburg - UKGM Giessen

    Gießen, 35392
    Germany

    Site Not Available

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20426
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hanover, 30625
    Germany

    Site Not Available

  • Universitätsklinikum Jena

    Jena, 07747
    Germany

    Site Not Available

  • Städtisches Klinikum Karlsruhe

    Karlsruhe, 76133
    Germany

    Site Not Available

  • Klinikum Kassel

    Kassel, 34125
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck, 23538
    Germany

    Site Not Available

  • Klinikum der Universität München

    München, 81336
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Münster, 48149
    Germany

    Site Not Available

  • UFK am Klinikum Südstradt Rostock

    Rostock, 18059
    Germany

    Site Not Available

  • Universitaätsklinikum Tübingen

    Tübingen, 72076
    Germany

    Site Not Available

  • Universitätsklinikum Ulm

    Ulm, 89075
    Germany

    Site Not Available

  • Klinikum Wolfsburg

    Wolfsburg, 38440
    Germany

    Site Not Available

  • Basavatarakam Indo-American Cancer Hospital & Research Institute

    Hyderabad, Telangana 500034
    India

    Site Not Available

  • Chittaranjan National Cancer Institute (CNCI)

    Kolkata, West Bengal 700026
    India

    Site Not Available

  • Istituto Europe di Oncologia

    Milano, 20141
    Italy

    Site Not Available

  • Ospedale San Gerardo Monza

    Monza, 20900
    Italy

    Site Not Available

  • San Gerardo Hospital

    Monza,
    Italy

    Active - Recruiting

  • Saitama Medical University International Medical Center

    Saitama,
    Japan

    Site Not Available

  • Oslo Universitetssykehus HF Radiumhospitalet

    Oslo, 0379
    Norway

    Site Not Available

  • National Oncology Institute

    Bratislava, 833 10
    Slovakia

    Site Not Available

  • University Hospital Bratislava

    Bratislava, 826 06
    Slovakia

    Site Not Available

  • University Hospital Trencin

    Trenčín, 911 01
    Slovakia

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitario Vall D´Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital General Universitario de Castellón

    Castelló de la Plana, 12004
    Spain

    Site Not Available

  • Hospital Universitario de Donostia

    Donostia, 20014
    Spain

    Site Not Available

  • Hopital Clinico Universitario de Valencia

    Girona, 17007
    Spain

    Site Not Available

  • Hospital Universitario de Girona Dr. Josep Trueta

    Girona, 17007
    Spain

    Site Not Available

  • Hospital Clínico Universitario San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Ramón y Caja

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Ramón y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Alvaro Cunqueiro

    Vigo, 36312
    Spain

    Site Not Available

  • CHUV

    Lausanne, 1011
    Switzerland

    Site Not Available

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