International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer
- Conditions
- Cervical Cancer
- Interventions
- Procedure: SLN biopsy + PLN dissectionProcedure: SLN biopsy only
- Registration Number
- NCT03386734
- Lead Sponsor
- Centre Hospitalier Universitaire de Besancon
- 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".
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 989
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.
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SLN biopsy + PLN dissection SLN biopsy + PLN dissection SLN biopsy + full pelvic lymph node dissection (PLN) will be performed. The radical hysterectomy or trachelectomy will be done. SLN biopsy only SLN biopsy only Sentinel lymph node (SLN) biopsy only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.
- Primary Outcome Measures
Name Time Method Disease Free Survival (DFS) 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.Health-related quality of life (HR-QoL) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (106)
CHC MontLégia
🇧🇪Liège, Belgium
CHU d'Amiens
🇫🇷Amiens, France
Hospital Universitario La Paz
🇪🇸Madrid, Spain
CHU de la Réunion
🇫🇷Saint-Denis, La Réunion, France
CHUV
🇨🇭Lausanne, Switzerland
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Erasto Gaertner
🇧🇷Curitiba, Parana, Brazil
Barretos Cancer Hospital
🇧🇷Campo Grande, Brazil
Brazilian National Cancer Institute
🇧🇷Rio De Janeiro, Brazil
AC Camargo Cancer Center - Sao Paulo
🇧🇷São Paulo, 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)
🇨🇦Montréal, Canada
CHUM Centre Hospitalier de l'Université de Montréal
🇨🇦Montréal, Canada
CHU Québec (Hôtel Dieu)
🇨🇦Québec, Canada
Allan Blair Cancer Centre (CASA)
🇨🇦Regina, Canada
Clinical Research Unit at Vancouver Coastal Health Authority (CAVG)
🇨🇦Vancouver, Canada
Saskatoon Cancer Centre.(CASS)
🇨🇦Saskatoon, Canada
CIUSS de l'Estrie - Centre hospitalier universitaire de Sherbrooke - CAGH
🇨🇦Sherbrooke, Canada
Cancer Hospital of University of Chinese Academy of Science
🇨🇳Hangzhou, Zhejiang, China
CancerCare Manitoba
🇨🇦Winnipeg, Canada
The 1st Affiliated Hospital
🇨🇳Wenzhou, China
University Hospital Olomouc
🇨🇿Olomouc, Czechia
University Hospital Ostrava
🇨🇿Ostrava-Poruba, Czechia
General University Hospital
🇨🇿Praha, Czechia
University Hospital Bulovka
🇨🇿Praha, Czechia
Grand Hôpital de l'Est Francilien
🇫🇷Paris, Marne-le-Vallée, France
CHU de Besançon
🇫🇷Besançon, France
Institut Bergonié
🇫🇷Bordeaux, France
Clinique Tivoli-Ducos
🇫🇷Bordeaux, France
Center de Lutte Contre le Cancer François Baclesse
🇫🇷Caen, France
CHU de Caen
🇫🇷Caen, France
CHU de Clermont-Ferrand - Hôpital d'Estaing
🇫🇷Clermont-Ferrand, France
CHU de Dijon Bourgogne
🇫🇷Dijon, France
Centre de Lutte Contre le Cancer Jean Perrin
🇫🇷Clermont-Ferrand, France
Hôpital Antoine Béclère
🇫🇷Clamart, France
CHI de Créteil
🇫🇷Créteil, France
Hôpital Bicêtre
🇫🇷Le Kremlin-Bicêtre, France
Centre Jean Godinot
🇫🇷Reims, France
Hôpital Européen Georges Pompidou
🇫🇷Paris, France
Centre Georges François Leclerc
🇫🇷Dijon, France
Centre Oscar Lambret
🇫🇷Lille, France
CHRU de Lille - Hôpital Jeanne de Flandre
🇫🇷Lille, France
Hôpitaux Universitaires de Strasbourg
🇫🇷Strasbourg, France
CHU de Limoges
🇫🇷Limoges, France
Hôpital de la Conception
🇫🇷Marseille, France
Groupement Hospitalier Est - Hôpital Femme Mère Enfant
🇫🇷Lyon, France
Institut de Cancérologie de Montpellier Val d'Aurelle
🇫🇷Montpellier, France
Hôpital Saint-Joseph
🇫🇷Marseille, France
Institut Paoli Calmettes
🇫🇷Marseille, France
CH de Mulhouse - Hôpital du Hasenrain
🇫🇷Mulhouse, France
Institut de Cancérologie de l'Ouest - Centre René Gauducheau
🇫🇷Nantes, France
Institut Curie - site de Paris
🇫🇷Paris, France
Centre de Lutte Contre le Cancer Antoine Lacassagne
🇫🇷Nice, France
Groupe Hospitalier Diaconesses Croix Saint Simon
🇫🇷Paris, France
Centre Hospitalier Bichat - Claude Bernard
🇫🇷Paris, France
Groupe Hospitalier la Pitié Salpêtrière
🇫🇷Paris, France
Hôpital de Poissy-Saint-Germain-en-Laye
🇫🇷Poissy, France
Hôpital Lariboisière
🇫🇷Paris, France
Hôpital Tenon
🇫🇷Paris, France
CH Lyon Sud
🇫🇷Pierre-Bénite, France
CHU de Poitiers - Hôpital de la Milétrie
🇫🇷Poitiers, France
Clinique Mathilde
🇫🇷Rouen, France
Centre Henri Becquerel
🇫🇷Rouen, France
CHU de Reims - Hôpital Robert Debré
🇫🇷Reims, France
CHU de Rennes - Hôpital Sud
🇫🇷Rennes, France
Institut de Cancérologie de Lorraine
🇫🇷Vandoeuvre les nancy, France
Centre de Lutte Contre le Cancer Gustave Roussy
🇫🇷Villejuif, France
Institut Universitaire du Cancer de Toulouse
🇫🇷Toulouse, France
Universitätsklinikum Düsseldorf
🇩🇪Düsseldorf, Germany
Vivantes Humboldt-Klinikum
🇩🇪Berlin, Germany
Universitätsklinikum Carl Gustav Carus
🇩🇪Dresden, Germany
Frauenklinik Fürth
🇩🇪Fürth, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Kliniken Essen Mitte, Evang. Huyssens-Stiftung
🇩🇪Essen, Germany
Florence-Nightingale-Krankenhaus
🇩🇪Düsseldorf, Germany
Universitätsklinikum Gießen und Marburg - UKGM Giessen
🇩🇪Gießen, Germany
Städtisches Klinikum Karlsruhe
🇩🇪Karlsruhe, Germany
Universitätsklinikum Jena
🇩🇪Jena, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Medizinische Hochschule Hannover
🇩🇪Hanover, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
🇩🇪Lübeck, Germany
Klinikum Kassel
🇩🇪Kassel, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Klinikum der Universität München
🇩🇪München, Germany
UFK am Klinikum Südstradt Rostock
🇩🇪Rostock, Germany
Universitaätsklinikum Tübingen
🇩🇪Tübingen, Germany
Klinikum Wolfsburg
🇩🇪Wolfsburg, Germany
Basavatarakam Indo-American Cancer Hospital & Research Institute
🇮🇳Hyderabad, Telangana, India
Istituto Europe di Oncologia
🇮🇹Milano, Italy
Chittaranjan National Cancer Institute (CNCI)
🇮🇳Kolkata, West Bengal, India
University Hospital Bratislava
🇸🇰Bratislava, Slovakia
Ospedale San Gerardo Monza
🇮🇹Monza, Italy
Saitama Medical University International Medical Center
🇯🇵Saitama, Japan
Oslo Universitetssykehus HF Radiumhospitalet
🇳🇴Oslo, Norway
National Oncology Institute
🇸🇰Bratislava, Slovakia
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
University Hospital Trencin
🇸🇰Trenčín, Slovakia
Hospital Universitario Vall D´Hebron
🇪🇸Barcelona, Spain
Hopital Clinico Universitario de Valencia
🇪🇸Girona, Spain
Hospital General Universitario de Castellón
🇪🇸Castelló de la Plana, Spain
Hospital Universitario de Girona Dr. Josep Trueta
🇪🇸Girona, Spain
Hospital Universitario de Donostia
🇪🇸Donostia, Spain
Hospital Alvaro Cunqueiro
🇪🇸Vigo, Spain
Hospital Clínico Universitario San Carlos
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain