Back to resultsInternational Validation Study of Sentinel Node Biopsy in Early Cervical Cancer (SENTICOLIII)
Primary Purpose
Cervical Cancer
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SLN biopsy only
SLN biopsy + PLN dissection
Sponsored by
About this trial
This is an interventional other trial for Cervical Cancer
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
Sites / Locations
- Cancer Hospital of University of Chinese Academy of ScienceRecruiting
- CHU de la RéunionRecruiting
- Grand Hôpital de l'Est FrancilienRecruiting
- CHU d'AmiensRecruiting
- Hôpital Henri Duffaut
- CHU de BesançonRecruiting
- Institut BergoniéRecruiting
- Clinique Tivoli-DucosRecruiting
- Center de Lutte Contre le Cancer François BaclesseRecruiting
- CHU de CaenRecruiting
- Hôpital Antoine BéclèreRecruiting
- Centre de Lutte Contre le Cancer Jean PerrinRecruiting
- CHU de Clermont-Ferrand - Hôpital d'EstaingRecruiting
- CHI de CréteilRecruiting
- CHU de Dijon BourgogneRecruiting
- Centre Georges François Leclerc
- Hôpital BicêtreRecruiting
- Centre Oscar LambretRecruiting
- CHRU de Lille - Hôpital Jeanne de FlandreRecruiting
- CHU de LimogesRecruiting
- Groupement Hospitalier Est - Hôpital Femme Mère EnfantRecruiting
- Hôpital de la ConceptionRecruiting
- Hôpital Saint-JosephRecruiting
- Institut Paoli CalmettesRecruiting
- Institut de Cancérologie de Montpellier Val d'AurelleRecruiting
- CH de Mulhouse - Hôpital du HasenrainRecruiting
- Institut de Cancérologie de l'Ouest - Centre René GauducheauRecruiting
- Centre de Lutte Contre le Cancer Antoine LacassagneRecruiting
- Institut CurieRecruiting
- Groupe Hospitalier Diaconesses Croix Saint SimonRecruiting
- Centre Hospitalier Bichat - Claude BernardRecruiting
- Groupe Hospitalier la Pitié SalpêtrièreRecruiting
- Hôpital Européen Georges PompidouRecruiting
- Hôpital LariboisièreRecruiting
- Hôpital TenonRecruiting
- CH Lyon SudRecruiting
- Hôpital de Poissy-Saint-Germain-en-LayeRecruiting
- CHU de Poitiers - Hôpital de la MilétrieRecruiting
- Centre Jean Godinot
- CHU de Reims - Hôpital Robert DebréRecruiting
- CHU de Rennes - Hôpital SudRecruiting
- Clinique MathildeRecruiting
- Centre Henri BecquerelRecruiting
- Hôpitaux Universitaires de StrasbourgRecruiting
- Institut Universitaire du Cancer de ToulouseRecruiting
- Institut de Cancérologie de LorraineRecruiting
- Centre de Lutte Contre le Cancer Gustave RoussyRecruiting
- San Gerardo HospitalRecruiting
- Saitama Medical University International Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SLN biopsy only
SLN biopsy + PLN dissection
Arm Description
Sentinel lymph node (SLN) biopsy only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.
SLN biopsy + full pelvic lymph node dissection (PLN) will be performed. The radical hysterectomy or trachelectomy will be done.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03386734
First Posted
December 15, 2017
Last Updated
July 27, 2022
Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
ARCAGY/ GINECO GROUP, European Network of Gynaecological Oncological Trial Groups (ENGOT)
1. Study Identification
Unique Protocol Identification Number
NCT03386734
Brief Title
International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer
Acronym
SENTICOLIII
Official Title
International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2018 (Actual)
Primary Completion Date
May 2027 (Anticipated)
Study Completion Date
May 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
ARCAGY/ GINECO GROUP, European Network of Gynaecological Oncological Trial Groups (ENGOT)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
988 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SLN biopsy only
Arm Type
Experimental
Arm Description
Sentinel lymph node (SLN) biopsy only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.
Arm Title
SLN biopsy + PLN dissection
Arm Type
Active Comparator
Arm Description
SLN biopsy + full pelvic lymph node dissection (PLN) will be performed. The radical hysterectomy or trachelectomy will be done.
Intervention Type
Procedure
Intervention Name(s)
SLN biopsy only
Intervention Description
In experimental arm, SLN dissection only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.
Intervention Type
Procedure
Intervention Name(s)
SLN biopsy + PLN dissection
Intervention Description
In active comparator arm, SLN dissection + full lymphadenectomy will be performed.
Primary Outcome Measure Information:
Title
Disease Free Survival (DFS)
Description
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.
Time Frame
Year 3
Title
Health-related quality of life (HR-QoL)
Description
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.
Time Frame
Year 3
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra Rohel
Phone
0033184852026
Email
arohel@arcagy.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina Mouyabi
Phone
0033381218356
Email
kmouyabi@chu-besancon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice Lecuru, MD PhD
Organizational Affiliation
Institut Curie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital of University of Chinese Academy of Science
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Qiang, MD
First Name & Middle Initial & Last Name & Degree
Qiang Wen, MD
Facility Name
CHU de la Réunion
City
Saint-Denis
State/Province
La Réunion
ZIP/Postal Code
97400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anca Paula Birsan Frances, MD
Facility Name
Grand Hôpital de l'Est Francilien
City
Paris
State/Province
Marne-le-Vallée
ZIP/Postal Code
77420
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Estelle WAFO, MD
Facility Name
CHU d'Amiens
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice Sergent, MD
Facility Name
Hôpital Henri Duffaut
City
Avignon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurène Lugans, MD
Facility Name
CHU de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajeev Ramanah, MD, PhD
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederic Guyon, MD
Facility Name
Clinique Tivoli-Ducos
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Richard, MD
Facility Name
Center de Lutte Contre le Cancer François Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandrine Martin-Françoise, MD
Facility Name
CHU de Caen
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raffaele Fauvet, MD PhD
Facility Name
Hôpital Antoine Béclère
City
Clamart
ZIP/Postal Code
92140
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Deffieux, MD PhD
Facility Name
Centre de Lutte Contre le Cancer Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Cornou, MD
Facility Name
CHU de Clermont-Ferrand - Hôpital d'Estaing
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Bourdel, MD
Facility Name
CHI de Créteil
City
Créteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer UZAN, MD
Facility Name
CHU de Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serge Douvier, MD PhD
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène COSTAZ, MD
Facility Name
Hôpital Bicêtre
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94270
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Perrine Capmas, MD
Facility Name
Centre Oscar Lambret
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice NARDUCCI, MD
Facility Name
CHRU de Lille - Hôpital Jeanne de Flandre
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérôme PHALIPPOU, MD
Facility Name
CHU de Limoges
City
Limoges
ZIP/Postal Code
87000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tristan Gauthier, MD PhD
Facility Name
Groupement Hospitalier Est - Hôpital Femme Mère Enfant
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gautier CHENE, MD PhD
Facility Name
Hôpital de la Conception
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrice CROCHET, MD
Facility Name
Hôpital Saint-Joseph
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth Chereau-Ewald, MD PhD
Facility Name
Institut Paoli Calmettes
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Lambaudie, MD
Facility Name
Institut de Cancérologie de Montpellier Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Emmanuel Colombo, MD
Facility Name
CH de Mulhouse - Hôpital du Hasenrain
City
Mulhouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramzi Kacem, MD
Facility Name
Institut de Cancérologie de l'Ouest - Centre René Gauducheau
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecile Loaëc, MD
First Name & Middle Initial & Last Name & Degree
Cecile Loaëc, MD
Facility Name
Centre de Lutte Contre le Cancer Antoine Lacassagne
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves Fouché, MD PhD
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Virginie Fourchotte, MD
Facility Name
Groupe Hospitalier Diaconesses Croix Saint Simon
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcos Ballester, MD, PhD
Facility Name
Centre Hospitalier Bichat - Claude Bernard
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Koskas, MD
Facility Name
Groupe Hospitalier la Pitié Salpêtrière
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérémie Belghiti, MD
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Sophie Bats, MD
Facility Name
Hôpital Lariboisière
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cyrille HUCHON, MD PhD
Facility Name
Hôpital Tenon
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofiane Bendifallah, MD
Facility Name
CH Lyon Sud
City
Pierre-Bénite
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Golfier, MD PhD
Facility Name
Hôpital de Poissy-Saint-Germain-en-Laye
City
Poissy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François MARGUERITTE, MD
Facility Name
CHU de Poitiers - Hôpital de la Milétrie
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amélie CHARVERIAT, MD
Facility Name
Centre Jean Godinot
City
Reims
ZIP/Postal Code
51100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion PONSART
Email
Marion.PONSART@reims.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Judicael HOTTON, MD
Facility Name
CHU de Reims - Hôpital Robert Debré
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Graesslin, MD PhD
Facility Name
CHU de Rennes - Hôpital Sud
City
Rennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Lavoue, MD PhD
Facility Name
Clinique Mathilde
City
Rouen
ZIP/Postal Code
76100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc BARON, MD
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agathe CROUZET, MD
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chérif AKLADIOS, MD PhD
Facility Name
Institut Universitaire du Cancer de Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gwenael Ferron, MD
Facility Name
Institut de Cancérologie de Lorraine
City
Vandoeuvre les nancy
ZIP/Postal Code
54500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric Marchal, MD PhD
Facility Name
Centre de Lutte Contre le Cancer Gustave Roussy
City
Villejuif
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien Gouy, MD
Facility Name
San Gerardo Hospital
City
Monza
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giampaolo Di Martino, MD
Facility Name
Saitama Medical University International Medical Center
City
Saitama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroshi Shinyama, PhD
Phone
0081448501731
Email
shinyama-ghr@kuhs.ac.jp
First Name & Middle Initial & Last Name & Degree
Akira Yabuno, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
30898938
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.
Results Reference
derived
Learn more about this trial
International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer
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