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Cervical CancerSENTICOLIIINCT03386734

International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer

A study testing SLN biopsy only and SLN biopsy + PLN dissection in people with Cervical Cancer, run by Centre Hospitalier Universitaire de Besancon at 106 sites in 14 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
SLN biopsy only and SLN biopsy + PLN dissection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
989 participants
Where
106 sitesin 14 countries
Study dates
3 May 2018to May 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

106 sites in 14 countries.

106 sites in 14 countries

France45 sites

  • CHU d'Amiens

    Amiens

  • CHU de Besançon

    Besançon, 25000

  • Institut Bergonié

    Bordeaux, 33000

  • Clinique Tivoli-Ducos

    Bordeaux

  • Center de Lutte Contre le Cancer François Baclesse

    Caen, 14000

  • CHU de Caen

    Caen

  • Hôpital Antoine Béclère

    Clamart, 92140

  • Centre de Lutte Contre le Cancer Jean Perrin

    Clermont-Ferrand, 63000

  • CHU de Clermont-Ferrand - Hôpital d'Estaing

    Clermont-Ferrand

  • CHI de Créteil

    Créteil, 94000

  • CHU de Dijon Bourgogne

    Dijon, 21000

  • Centre Georges François Leclerc

    Dijon, 21079

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270

  • Centre Oscar Lambret

    Lille

  • CHRU de Lille - Hôpital Jeanne de Flandre

    Lille

  • CHU de Limoges

    Limoges, 87000

  • Groupement Hospitalier Est - Hôpital Femme Mère Enfant

    Lyon

  • Hôpital de la Conception

    Marseille

  • Hôpital Saint-Joseph

    Marseille

  • Institut Paoli Calmettes

    Marseille

  • Institut de Cancérologie de Montpellier Val d'Aurelle

    Montpellier, 34000

  • CH de Mulhouse - Hôpital du Hasenrain

    Mulhouse

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

    Nantes

  • Centre de Lutte Contre le Cancer Antoine Lacassagne

    Nice, 06000

  • Grand Hôpital de l'Est Francilien

    Paris, Marne-le-Vallée, 77420

  • Institut Curie - site de Paris

    Paris, 75005

  • Groupe Hospitalier Diaconesses Croix Saint Simon

    Paris, 75020

  • Centre Hospitalier Bichat - Claude Bernard

    Paris

  • Groupe Hospitalier la Pitié Salpêtrière

    Paris

  • Hôpital Européen Georges Pompidou

    Paris

  • Hôpital Lariboisière

    Paris

  • Hôpital Tenon

    Paris

  • CH Lyon Sud

    Pierre-Bénite

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

    Poissy

  • CHU de Poitiers - Hôpital de la Milétrie

    Poitiers

  • Centre Jean Godinot

    Reims, 51100

  • CHU de Reims - Hôpital Robert Debré

    Reims

  • CHU de Rennes - Hôpital Sud

    Rennes

  • Clinique Mathilde

    Rouen, 76100

  • Centre Henri Becquerel

    Rouen

  • CHU de la Réunion

    Saint-Denis, La Réunion, 97400

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg

  • Institut Universitaire du Cancer de Toulouse

    Toulouse, 31000

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54500

  • Centre de Lutte Contre le Cancer Gustave Roussy

    Villejuif

Other trials in France

Germany19 sites

  • Vivantes Humboldt-Klinikum

    Berlin, 13509

  • Universitätsklinikum Carl Gustav Carus

    Dresden, 01307

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Florence-Nightingale-Krankenhaus

    Düsseldorf, 40489

  • Kliniken Essen Mitte, Evang. Huyssens-Stiftung

    Essen, 45136

  • Frauenklinik Fürth

    Fürth, 90766

  • Universitätsklinikum Gießen und Marburg - UKGM Giessen

    Giessen, 35392

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20426

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Jena

    Jena, 07747

  • Städtisches Klinikum Karlsruhe

    Karlsruhe, 76133

  • Klinikum Kassel

    Kassel, 34125

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck, 23538

  • Klinikum der Universität München

    München, 81336

  • Universitätsklinikum Münster

    Münster, 48149

  • UFK am Klinikum Südstradt Rostock

    Rostock, 18059

  • Universitaätsklinikum Tübingen

    Tübingen, 72076

  • Universitätsklinikum Ulm

    Ulm, 89075

  • Klinikum Wolfsburg

    Wolfsburg, 38440

Other trials in Germany

Spain11 sites

  • Hospital Universitario Vall D´Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital General Universitario de Castellón

    Castellon, 12004

  • Hospital Universitario de Donostia

    Donostia / San Sebastian, 20014

  • Hopital Clinico Universitario de Valencia

    Girona, 17007

  • Hospital Universitario de Girona Dr. Josep Trueta

    Girona, 17007

  • Hospital Ramón y Cajal

    Madrid, 28034

  • Hospital Clínico Universitario San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Alvaro Cunqueiro

    Vigo, 36312

Other trials in Spain

Canada8 sites

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

    Montreal, QC H1T 2M4

  • CHUM Centre Hospitalier de l'Université de Montréal

    Montreal

  • CHU Québec (Hôtel Dieu)

    Québec

  • Allan Blair Cancer Centre (CASA)

    Regina

  • Saskatoon Cancer Centre.(CASS)

    Saskatoon

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

    Sherbrooke, J1G 1B1

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

    Vancouver, BC V5Z 1M9

  • CancerCare Manitoba

    Winnipeg, R3E 0V9

Other trials in Canada

Brazil6 sites

  • Barretos Cancer Hospital

    Campo Grande, 79085-039

  • Hospital Erasto Gaertner

    Curitiba, Paraná

  • Brazilian National Cancer Institute

    Rio de Janeiro, 3709

  • AC Camargo Cancer Center - Sao Paulo

    São Paulo, 01525-001

  • Hospital Amaral Carvalho de Jaù

    São Paulo

  • Hospital Israelita Albert Einstein

    São Paulo

Other trials in Brazil

Czechia4 sites

  • University Hospital Olomouc

    Olomouc, 779 00

  • University Hospital Ostrava

    Ostrava-Poruba, 708 00

  • General University Hospital

    Prague, 128 51

  • University Hospital Bulovka

    Prague, 180-81

Other trials in Czechia

Slovakia3 sites

  • University Hospital Bratislava

    Bratislava, 826 06

  • National Oncology Institute

    Bratislava, 833 10

  • University Hospital Trencin

    Trenčín, 911 01

Other trials in Slovakia

China2 sites

  • Cancer Hospital of University of Chinese Academy of Science

    Hangzhou, Zhejiang, 310022

  • The 1st Affiliated Hospital

    Wenzhou, 325015

Other trials in China

India2 sites

  • Basavatarakam Indo-American Cancer Hospital & Research Institute

    Hyderabad, Telangana, 500034

  • Chittaranjan National Cancer Institute (CNCI)

    Kolkata, West Bengal, 700026

Other trials in India

Italy2 sites

  • Istituto Europe di Oncologia

    Milan, 20141

  • Ospedale San Gerardo Monza

    Monza, 20900

Other trials in Italy

Belgium1 site

  • CHC MontLégia

    Liège, 4000

Other trials in Belgium

Japan1 site

  • Saitama Medical University International Medical Center

    Saitama

Other trials in Japan

Norway1 site

  • Oslo Universitetssykehus HF Radiumhospitalet

    Oslo, 0379

Other trials in Norway

Switzerland1 site

  • CHUV

    Lausanne, 1011

Other trials in Switzerland

About this study

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
Being tested
SLN biopsy only, SLN biopsy + PLN dissection
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SLN biopsy onlyProcedure or surgery

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

  • SLN biopsy + PLN dissectionProcedure or surgery

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

Study groups in NCT03386734
Study groupRoleWhat they receive
SLN biopsy onlyExperimentalSentinel lymph node (SLN) biopsy only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.
Receives: Procedure: SLN biopsy only
SLN biopsy + PLN dissectionActive comparatorSLN biopsy + full pelvic lymph node dissection (PLN) will be performed. The radical hysterectomy or trachelectomy will be done.
Receives: Procedure: SLN biopsy + PLN dissection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Year 3

  2. 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.

    Measured: Year 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2017
  2. Study start3 May 2018
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
989 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03386734
Sponsor's protocol ID
N/2016/72
Other IDs
ENGOT-Cx4, GINECO-CE106
Acronym
SENTICOLIII
Status last verified
Jul 2024
First submitted
15 Dec 2017
Last updated
8 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37650664

  • 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.

    PubMed 30898938

Questions about this trial

What is this clinical trial studying?

A study testing SLN biopsy only and SLN biopsy + PLN dissection in people with Cervical Cancer, run by Centre Hospitalier Universitaire de Besancon at 106 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in France, Germany, Spain, Canada, Brazil and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Free Survival (DFS) (time frame: Year 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03386734, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.

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