International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer
SENTICOLIII
3 other identifiers
interventional
989
14 countries
106
Brief 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".
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2018
Longer than P75 for not_applicable
106 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2017
CompletedFirst Posted
Study publicly available on registry
December 29, 2017
CompletedStudy Start
First participant enrolled
May 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2029
July 8, 2024
July 1, 2024
9 years
December 15, 2017
July 5, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Disease Free Survival (DFS)
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)
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
Study Arms (2)
SLN biopsy only
EXPERIMENTALSentinel lymph node (SLN) biopsy only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.
SLN biopsy + PLN dissection
ACTIVE COMPARATORSLN biopsy + full pelvic lymph node dissection (PLN) will be performed. The radical hysterectomy or trachelectomy will be done.
Interventions
In experimental arm, SLN dissection only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.
In active comparator arm, SLN dissection + full lymphadenectomy will be performed.
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (106)
CHC MontLégia
Liège, 4000, Belgium
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
Barretos Cancer Hospital
Campo Grande, 79085-039, Brazil
Brazilian National Cancer Institute
Rio de Janeiro, 3709, Brazil
AC Camargo Cancer Center - Sao Paulo
São Paulo, 01525-001, Brazil
Hospital Amaral Carvalho de Jaù
São Paulo, Brazil
Hospital Israelita Albert Einstein
São Paulo, Brazil
CIUSSS de l'Est-de-I'lle-de-Montreal Hopital Maisonneuve-Rosemont (CAHA)
Montreal, QC H1T 2M4, Canada
CHUM Centre Hospitalier de l'Université de Montréal
Montreal, Canada
CHU Québec (Hôtel Dieu)
Québec, Canada
Allan Blair Cancer Centre (CASA)
Regina, Canada
Saskatoon Cancer Centre.(CASS)
Saskatoon, Canada
CIUSS de l'Estrie - Centre hospitalier universitaire de Sherbrooke - CAGH
Sherbrooke, J1G 1B1, Canada
Clinical Research Unit at Vancouver Coastal Health Authority (CAVG)
Vancouver, BC V5Z 1M9, Canada
CancerCare Manitoba
Winnipeg, R3E 0V9, Canada
Cancer Hospital of University of Chinese Academy of Science
Hangzhou, Zhejiang, 310022, China
The 1st Affiliated Hospital
Wenzhou, 325015, China
University Hospital Olomouc
Olomouc, 779 00, Czechia
University Hospital Ostrava
Ostrava-Poruba, 708 00, Czechia
General University Hospital
Prague, 128 51, Czechia
University Hospital Bulovka
Prague, 180-81, Czechia
CHU de la Réunion
Saint-Denis, La Réunion, 97400, France
Grand Hôpital de l'Est Francilien
Paris, Marne-le-Vallée, 77420, France
CHU d'Amiens
Amiens, France
CHU de Besançon
Besançon, 25000, France
Institut Bergonié
Bordeaux, 33000, France
Clinique Tivoli-Ducos
Bordeaux, France
Center de Lutte Contre le Cancer François Baclesse
Caen, 14000, France
CHU de Caen
Caen, France
Hôpital Antoine Béclère
Clamart, 92140, France
Centre de Lutte Contre le Cancer Jean Perrin
Clermont-Ferrand, 63000, France
CHU de Clermont-Ferrand - Hôpital d'Estaing
Clermont-Ferrand, France
CHI de Créteil
Créteil, 94000, France
CHU de Dijon Bourgogne
Dijon, 21000, France
Centre Georges François Leclerc
Dijon, 21079, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270, France
Centre Oscar Lambret
Lille, France
CHRU de Lille - Hôpital Jeanne de Flandre
Lille, France
CHU de Limoges
Limoges, 87000, France
Groupement Hospitalier Est - Hôpital Femme Mère Enfant
Lyon, France
Hôpital de la Conception
Marseille, France
Hôpital Saint-Joseph
Marseille, France
Institut Paoli Calmettes
Marseille, France
Institut de Cancérologie de Montpellier Val d'Aurelle
Montpellier, 34000, France
CH de Mulhouse - Hôpital du Hasenrain
Mulhouse, France
Institut de Cancérologie de l'Ouest - Centre René Gauducheau
Nantes, France
Centre de Lutte Contre le Cancer Antoine Lacassagne
Nice, 06000, France
Institut Curie - site de Paris
Paris, 75005, France
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, 75020, France
Centre Hospitalier Bichat - Claude Bernard
Paris, France
Groupe Hospitalier la Pitié Salpêtrière
Paris, France
Hôpital Européen Georges Pompidou
Paris, France
Hôpital Lariboisière
Paris, France
Hôpital Tenon
Paris, France
CH Lyon Sud
Pierre-Bénite, France
Hôpital de Poissy-Saint-Germain-en-Laye
Poissy, France
CHU de Poitiers - Hôpital de la Milétrie
Poitiers, France
Centre Jean Godinot
Reims, 51100, France
CHU de Reims - Hôpital Robert Debré
Reims, France
CHU de Rennes - Hôpital Sud
Rennes, France
Clinique Mathilde
Rouen, 76100, France
Centre Henri Becquerel
Rouen, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Institut Universitaire du Cancer de Toulouse
Toulouse, 31000, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54500, France
Centre de Lutte Contre le Cancer Gustave Roussy
Villejuif, France
Vivantes Humboldt-Klinikum
Berlin, 13509, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, 01307, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, 40225, Germany
Florence-Nightingale-Krankenhaus
Düsseldorf, 40489, Germany
Kliniken Essen Mitte, Evang. Huyssens-Stiftung
Essen, 45136, Germany
Frauenklinik Fürth
Fürth, 90766, Germany
Universitätsklinikum Gießen und Marburg - UKGM Giessen
Giessen, 35392, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20426, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitätsklinikum Jena
Jena, 07747, Germany
Städtisches Klinikum Karlsruhe
Karlsruhe, 76133, Germany
Klinikum Kassel
Kassel, 34125, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, 23538, Germany
Klinikum der Universität München
München, 81336, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
UFK am Klinikum Südstradt Rostock
Rostock, 18059, Germany
Universitaätsklinikum Tübingen
Tübingen, 72076, Germany
Universitätsklinikum Ulm
Ulm, 89075, Germany
Klinikum Wolfsburg
Wolfsburg, 38440, Germany
Basavatarakam Indo-American Cancer Hospital & Research Institute
Hyderabad, Telangana, 500034, India
Chittaranjan National Cancer Institute (CNCI)
Kolkata, West Bengal, 700026, India
Istituto Europe di Oncologia
Milan, 20141, Italy
Ospedale San Gerardo Monza
Monza, 20900, Italy
Saitama Medical University International Medical Center
Saitama, Japan
Oslo Universitetssykehus HF Radiumhospitalet
Oslo, 0379, Norway
University Hospital Bratislava
Bratislava, 826 06, Slovakia
National Oncology Institute
Bratislava, 833 10, Slovakia
University Hospital Trencin
Trenčín, 911 01, Slovakia
Hospital Universitario Vall D´Hebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital General Universitario de Castellón
Castellon, 12004, Spain
Hospital Universitario de Donostia
Donostia / San Sebastian, 20014, Spain
Hopital Clinico Universitario de Valencia
Girona, 17007, Spain
Hospital Universitario de Girona Dr. Josep Trueta
Girona, 17007, Spain
Hospital Ramón y Cajal
Madrid, 28034, Spain
Hospital Clínico Universitario San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Alvaro Cunqueiro
Vigo, 36312, Spain
CHUV
Lausanne, 1011, Switzerland
Related Publications (2)
Boisen M, Guido R. Emerging Treatment Options for Cervical Dysplasia and Early Cervical Cancer. Clin Obstet Gynecol. 2023 Sep 1;66(3):500-515. doi: 10.1097/GRF.0000000000000790. Epub 2023 Jul 25.
PMID: 37650664DERIVEDLecuru FR, McCormack M, Hillemanns P, Anota A, Leitao M, Mathevet P, Zweemer R, Fujiwara K, Zanagnolo V, Zahl Eriksson AG, Hudson E, Ferron G, Plante M. SENTICOL III: an international validation study of sentinel node biopsy in early cervical cancer. A GINECO, ENGOT, GCIG and multicenter study. Int J Gynecol Cancer. 2019 May;29(4):829-834. doi: 10.1136/ijgc-2019-000332. Epub 2019 Mar 20.
PMID: 30898938DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabrice Lecuru, MD PhD
Institut Curie
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2017
First Posted
December 29, 2017
Study Start
May 3, 2018
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2029
Last Updated
July 8, 2024
Record last verified: 2024-07