International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer

NCT ID: NCT03386734

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 989 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-03
• Study Completion Date: 2029-05-31

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".

Conditions

Cervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

SLN biopsy only

Sentinel lymph node (SLN) biopsy only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.

Group Type: EXPERIMENTAL

SLN biopsy only

Intervention Type: PROCEDURE

In experimental arm, SLN dissection only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.

SLN biopsy + PLN dissection

SLN biopsy + full pelvic lymph node dissection (PLN) will be performed. The radical hysterectomy or trachelectomy will be done.

Group Type: ACTIVE_COMPARATOR

SLN biopsy + PLN dissection

Intervention Type: PROCEDURE

In active comparator arm, SLN dissection + full lymphadenectomy will be performed.

Interventions

SLN biopsy only

In experimental arm, SLN dissection only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.

Intervention Type: PROCEDURE

SLN biopsy + PLN dissection

In active comparator arm, SLN dissection + full lymphadenectomy will be performed.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ARCAGY/ GINECO GROUP

OTHER

Sponsor Role: collaborator

European Network of Gynaecological Oncological Trial Groups (ENGOT)

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabrice Lecuru, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Curie

Locations

CHC MontLégia

Liège, , Belgium

Hospital Erasto Gaertner

Curitiba, Paraná, 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)

Montreal, , 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, , Canada

Clinical Research Unit at Vancouver Coastal Health Authority (CAVG)

Vancouver, , Canada

CancerCare Manitoba

Winnipeg, , Canada

Cancer Hospital of University of Chinese Academy of Science

Hangzhou, Zhejiang, China

The 1st Affiliated Hospital

Wenzhou, , China

University Hospital Olomouc

Olomouc, , Czechia

University Hospital Ostrava

Ostrava-Poruba, , Czechia

General University Hospital

Prague, , Czechia

University Hospital Bulovka

Prague, , Czechia

CHU de la Réunion

Saint-Denis, La Réunion, France

Grand Hôpital de l'Est Francilien

Paris, Marne-le-Vallée, France

CHU d'Amiens

Amiens, , 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

Hôpital Antoine Béclère

Clamart, , France

Centre de Lutte Contre le Cancer Jean Perrin

Clermont-Ferrand, , France

CHU de Clermont-Ferrand - Hôpital d'Estaing

Clermont-Ferrand, , France

CHI de Créteil

Créteil, , France

CHU de Dijon Bourgogne

Dijon, , France

Centre Georges François Leclerc

Dijon, , France

Hôpital Bicêtre

Le Kremlin-Bicêtre, , France

Centre Oscar Lambret

Lille, , France

CHRU de Lille - Hôpital Jeanne de Flandre

Lille, , France

CHU de Limoges

Limoges, , 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, , 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, , France

Institut Curie - site de Paris

Paris, , France

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, , 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, , France

CHU de Reims - Hôpital Robert Debré

Reims, , France

CHU de Rennes - Hôpital Sud

Rennes, , France

Clinique Mathilde

Rouen, , France

Centre Henri Becquerel

Rouen, , France

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Institut Universitaire du Cancer de Toulouse

Toulouse, , France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, , France

Centre de Lutte Contre le Cancer Gustave Roussy

Villejuif, , France

Vivantes Humboldt-Klinikum

Berlin, , Germany

Universitätsklinikum Carl Gustav Carus

Dresden, , Germany

Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Florence-Nightingale-Krankenhaus

Düsseldorf, , Germany

Kliniken Essen Mitte, Evang. Huyssens-Stiftung

Essen, , Germany

Frauenklinik Fürth

Fürth, , Germany

Universitätsklinikum Gießen und Marburg - UKGM Giessen

Giessen, , Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Universitätsklinikum Jena

Jena, , Germany

Städtisches Klinikum Karlsruhe

Karlsruhe, , Germany

Klinikum Kassel

Kassel, , Germany

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, , Germany

Klinikum der Universität München

München, , Germany

Universitätsklinikum Münster

Münster, , Germany

UFK am Klinikum Südstradt Rostock

Rostock, , Germany

Universitaätsklinikum Tübingen

Tübingen, , Germany

Universitätsklinikum Ulm

Ulm, , Germany

Klinikum Wolfsburg

Wolfsburg, , Germany

Basavatarakam Indo-American Cancer Hospital & Research Institute

Hyderabad, Telangana, India

Chittaranjan National Cancer Institute (CNCI)

Kolkata, West Bengal, India

Istituto Europe di Oncologia

Milan, , Italy

Ospedale San Gerardo Monza

Monza, , Italy

Saitama Medical University International Medical Center

Saitama, , Japan

Oslo Universitetssykehus HF Radiumhospitalet

Oslo, , Norway

University Hospital Bratislava

Bratislava, , Slovakia

National Oncology Institute

Bratislava, , Slovakia

University Hospital Trencin

Trenčín, , Slovakia

Hospital Universitario Vall D´Hebron

Barcelona, , Spain

Hospital Clinic de Barcelona

Barcelona, , Spain

Hospital General Universitario de Castellón

Castellon, , Spain

Hospital Universitario de Donostia

Donostia / San Sebastian, , Spain

Hopital Clinico Universitario de Valencia

Girona, , Spain

Hospital Universitario de Girona Dr. Josep Trueta

Girona, , Spain

Hospital Ramón y Cajal

Madrid, , Spain

Hospital Clínico Universitario San Carlos

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Alvaro Cunqueiro

Vigo, , Spain

CHUV

Lausanne, , Switzerland

Countries

Belgium; Brazil; Canada; China; Czechia; France; Germany; India; Italy; Japan; Norway; Slovakia; Spain; Switzerland

References

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.

Reference Type: DERIVED

PMID: 37650664 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30898938 (View on PubMed)

Other Identifiers

ENGOT-Cx4

Identifier Type: OTHER

Identifier Source: secondary_id

GINECO-CE106

Identifier Type: OTHER

Identifier Source: secondary_id

N/2016/72

Identifier Type: -

Identifier Source: org_study_id