Clinical trial NCT03386734: International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer
Official title: International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cervical Cancer
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: ARCAGY/ GINECO GROUP
name: European Network of Gynaecological Oncological Trial Groups (ENGOT)
First posted: 2017-12-29
Enrollment: 989
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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".


Eligibility criteria: 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

Primary outcomes:
measure: Disease Free Survival (DFS)
timeFrame: Year 3
measure: Health-related quality of life (HR-QoL)
timeFrame: Year 3
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHC MontLégia
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner
state: Parana
city: Campo Grande
country: Brazil
facility: Barretos Cancer Hospital
city: Rio De Janeiro
country: Brazil
facility: Brazilian National Cancer Institute
city: São Paulo
country: Brazil
facility: AC Camargo Cancer Center - Sao Paulo
city: São Paulo
country: Brazil
facility: Hospital Amaral Carvalho de Jaù
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
city: Montréal
country: Canada
facility: CIUSSS de l'Est-de-I'lle-de-Montreal Hopital Maisonneuve-Rosemont (CAHA)
city: Montréal
country: Canada
facility: CHUM Centre Hospitalier de l'Université de Montréal
city: Québec
country: Canada
facility: CHU Québec (Hôtel Dieu)
city: Regina
country: Canada
facility: Allan Blair Cancer Centre (CASA)
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre.(CASS)
city: Sherbrooke
country: Canada
facility: CIUSS de l'Estrie - Centre hospitalier universitaire de Sherbrooke - CAGH
city: Vancouver
country: Canada
facility: Clinical Research Unit at Vancouver Coastal Health Authority (CAVG)
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
city: Hangzhou
country: China
facility: Cancer Hospital of University of Chinese Academy of Science
state: Zhejiang
city: Wenzhou
country: China
facility: The 1st Affiliated Hospital
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
city: Ostrava-Poruba
country: Czechia
facility: University Hospital Ostrava
city: Praha
country: Czechia
facility: General University Hospital
city: Praha
country: Czechia
facility: University Hospital Bulovka
city: Saint-Denis
country: France
facility: CHU de la Réunion
state: La Réunion
city: Paris
country: France
facility: Grand Hôpital de l'Est Francilien
state: Marne-le-Vallée
city: Amiens
country: France
facility: CHU d'Amiens
city: Besançon
country: France
facility: CHU de Besançon
city: Bordeaux
country: France
facility: Institut Bergonié
city: Bordeaux
country: France
facility: Clinique Tivoli-Ducos
city: Caen
country: France
facility: Center de Lutte Contre le Cancer François Baclesse
city: Caen
country: France
facility: CHU de Caen
city: Clamart
country: France
facility: Hôpital Antoine Béclère
city: Clermont-Ferrand
country: France
facility: Centre de Lutte Contre le Cancer Jean Perrin
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand - Hôpital d'Estaing
city: Créteil
country: France
facility: CHI de Créteil
city: Dijon
country: France
facility: CHU de Dijon Bourgogne
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: CHRU de Lille - Hôpital Jeanne de Flandre
city: Limoges
country: France
facility: CHU de Limoges
city: Lyon
country: France
facility: Groupement Hospitalier Est - Hôpital Femme Mère Enfant
city: Marseille
country: France
facility: Hôpital de la Conception
city: Marseille
country: France
facility: Hôpital Saint-Joseph
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: Institut de Cancérologie de Montpellier Val d'Aurelle
city: Mulhouse
country: France
facility: CH de Mulhouse - Hôpital du Hasenrain
city: Nantes
country: France
facility: Institut de Cancérologie de l'Ouest - Centre René Gauducheau
city: Nice
country: France
facility: Centre de Lutte Contre le Cancer Antoine Lacassagne
city: Paris
country: France
facility: Institut Curie - site de Paris
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses Croix Saint Simon
city: Paris
country: France
facility: Centre Hospitalier Bichat - Claude Bernard
city: Paris
country: France
facility: Groupe Hospitalier la Pitié Salpêtrière
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hôpital Tenon
city: Pierre-Bénite
country: France
facility: CH Lyon Sud
city: Poissy
country: France
facility: Hôpital de Poissy-Saint-Germain-en-Laye
city: Poitiers
country: France
facility: CHU de Poitiers - Hôpital de la Milétrie
city: Reims
country: France
facility: Centre Jean Godinot
city: Reims
country: France
facility: CHU de Reims - Hôpital Robert Debré
city: Rennes
country: France
facility: CHU de Rennes - Hôpital Sud
city: Rouen
country: France
facility: Clinique Mathilde
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
city: Toulouse
country: France
facility: Institut Universitaire du Cancer de Toulouse
city: Vandoeuvre les nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Villejuif
country: France
facility: Centre de Lutte Contre le Cancer Gustave Roussy
city: Berlin
country: Germany
facility: Vivantes Humboldt-Klinikum
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Düsseldorf
country: Germany
facility: Florence-Nightingale-Krankenhaus
city: Essen
country: Germany
facility: Kliniken Essen Mitte, Evang. Huyssens-Stiftung
city: Fürth
country: Germany
facility: Frauenklinik Fürth
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg - UKGM Giessen
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hanover
country: Germany
facility: Medizinische Hochschule Hannover
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe
city: Kassel
country: Germany
facility: Klinikum Kassel
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck
city: München
country: Germany
facility: Klinikum der Universität München
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Rostock
country: Germany
facility: UFK am Klinikum Südstradt Rostock
city: Tübingen
country: Germany
facility: Universitaätsklinikum Tübingen
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Wolfsburg
country: Germany
facility: Klinikum Wolfsburg
city: Hyderabad
country: India
facility: Basavatarakam Indo-American Cancer Hospital & Research Institute
state: Telangana
city: Kolkata
country: India
facility: Chittaranjan National Cancer Institute (CNCI)
state: West Bengal
city: Milano
country: Italy
facility: Istituto Europe di Oncologia
city: Monza
country: Italy
facility: Ospedale San Gerardo Monza
city: Saitama
country: Japan
facility: Saitama Medical University International Medical Center
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF Radiumhospitalet
city: Bratislava
country: Slovakia
facility: University Hospital Bratislava
city: Bratislava
country: Slovakia
facility: National Oncology Institute
city: Trenčín
country: Slovakia
facility: University Hospital Trencin
city: Barcelona
country: Spain
facility: Hospital Universitario Vall D´Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Castelló de la Plana
country: Spain
facility: Hospital General Universitario de Castellón
city: Donostia
country: Spain
facility: Hospital Universitario de Donostia
city: Girona
country: Spain
facility: Hopital Clinico Universitario de Valencia
city: Girona
country: Spain
facility: Hospital Universitario de Girona Dr. Josep Trueta
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clínico Universitario San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
city: Lausanne
country: Switzerland
facility: CHUV
Study officials:
affiliation: Institut Curie
name: Fabrice Lecuru, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lecuru 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.