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International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer (SENTICOLIII)

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ClinicalTrials.gov Identifier: NCT03386734
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : October 25, 2018
Sponsor:
Collaborators:
ARCAGY/ GINECO GROUP
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Information provided by (Responsible Party):
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".


Condition or disease Intervention/treatment Phase
Cervical Cancer Procedure: SLN biopsy only Procedure: SLN biopsy + PLN dissection Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 950 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer
Actual Study Start Date : May 3, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SLN biopsy only
Sentinel lymph node (SLN) biopsy only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.
Procedure: SLN biopsy only
In experimental arm, SLN dissection only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.

Active Comparator: SLN biopsy + PLN dissection
SLN biopsy + full pelvic lymph node dissection (PLN) will be performed. The radical hysterectomy or trachelectomy will be done.
Procedure: SLN biopsy + PLN dissection
In active comparator arm, SLN dissection + full lymphadenectomy will be performed.




Primary Outcome Measures :
  1. Disease Free Survival (DFS) [ Time Frame: 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.


  2. Health-related quality of life (HR-QoL) [ Time Frame: 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • With squamous or adenocarcinoma of the cervix (proven by biopsy or cone biopsy),
  • Stage Ia1 with lymphovascular emboli, Ia2, Ib1 and IIa1 (clinical stage) of the 2009 FIGO classification,
  • Maximum diameter ≤ 40 mm by clinical examination and magnetic resonance imaging (MRI),
  • INo suspicious node on pelvic and abdominal MRI with an exploration up to the femoralleft renal vein (according to RECIST 1.1),
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-2,
  • Signed informed consent and ability to comply with follow-up,
  • 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:

  • Pregnancy,
  • Previous pelvic or abdominal cancer,
  • Previous chemotherapy and/or radiation therapy for the cervical cancer (previous brachytherapy is accepted),
  • Proven allergy to blue dye, isotope or indocyanine green (ICG).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386734


Contacts
Contact: Sylvie Mijonnet 0033142348323 smijonnet@arcagy.org
Contact: Kristina Mouyabi 0033381218356 kmouyabi@chu-besancon.fr

Locations
France
CHU de la Réunion Not yet recruiting
Saint-Denis, La Réunion, France, 97400
Contact: Anca Paula Birsan Frances, MD         
CHU d'Amiens Recruiting
Amiens, France
Contact: Fabrice Sergent, MD         
Hôpital Henri Duffaut Not yet recruiting
Avignon, France
Contact: Laurène Lugans, MD         
CHU de Besançon Not yet recruiting
Besançon, France, 25000
Contact: Rajeev Ramanah, MD, PhD         
Institut Bergonié Not yet recruiting
Bordeaux, France, 33000
Contact: Frederic Guyon, MD         
Clinique Tivoli-Ducos Recruiting
Bordeaux, France
Contact: Sophie Richard, MD         
Center de Lutte Contre le Cancer François Baclesse Not yet recruiting
Caen, France, 14000
Contact: Sandrine Martin-Françoise, MD         
CHU de Caen Recruiting
Caen, France
Contact: Raffaele Fauvet, MD PhD         
Hôpital Antoine Béclère Not yet recruiting
Clamart, France, 92140
Contact: Xavier Deffieux, MD PhD         
Centre de Lutte Contre le Cancer Jean Perrin Not yet recruiting
Clermont-Ferrand, France, 63000
Contact: Caroline Cornou, MD         
CHU de Clermont-Ferrand - Hôpital d'Estaing Not yet recruiting
Clermont-Ferrand, France
Contact: Bourdel Nicolas, MD         
CHI de Créteil Not yet recruiting
Créteil, France, 94000
Contact: Cyril Touboul, MD PhD         
CHU de Dijon Bourgogne Not yet recruiting
Dijon, France, 21000
Contact: Serge Douvier, MD PhD         
Hôpital Bicêtre Not yet recruiting
Le Kremlin-Bicêtre, France, 94270
Contact: Perrine Capmas, MD         
Centre Oscar Lambret Not yet recruiting
Lille, France
Contact: Eric Leblanc, MD         
CHRU de Lille - Hôpital Jeanne de Flandre Not yet recruiting
Lille, France
Contact: Pierre Collinet, MD PhD         
CHU de Limoges Not yet recruiting
Limoges, France, 87000
Contact: Tristan Gauthier, MD PhD         
Groupement Hospitalier Est - Hôpital Femme Mère Enfant Not yet recruiting
Lyon, France
Contact: Gautier Chene, MD         
Hôpital de la Conception Not yet recruiting
Marseille, France
Contact: Aubert Agostini, MD PhD         
Hôpital Saint-Joseph Not yet recruiting
Marseille, France
Contact: Elisabeth Chereau-Ewald, MD PhD         
Institut Paoli Calmettes Recruiting
Marseille, France
Contact: Eric Lambaudie, MD         
Institut de Cancérologie de Montpellier Val d'Aurelle Recruiting
Montpellier, France, 34000
Contact: Pierre-Emmanuel Colombo, MD         
CH de Mulhouse - Hôpital du Hasenrain Not yet recruiting
Mulhouse, France
Contact: Ramzi Kacem, MD         
Institut de Cancérologie de l'Ouest - Centre René Gauducheau Not yet recruiting
Nantes, France
Centre de Lutte Contre le Cancer Antoine Lacassagne Not yet recruiting
Nice, France, 06000
Contact: Yves Fouché, MD         
Institut Curie Not yet recruiting
Paris, France, 75005
Contact: Virginie Fourchotte, MD         
Groupe Hospitalier Diaconesses Croix Saint Simon Not yet recruiting
Paris, France, 75020
Centre Hospitalier Bichat - Claude Bernard Recruiting
Paris, France
Contact: Martin Koskas, MD         
Groupe Hospitalier la Pitié Salpêtrière Not yet recruiting
Paris, France
Contact: Catherine Uzan, MD PhD         
Hôpital Européen Georges Pompidou Recruiting
Paris, France
Contact: Fabrice Lécuru, MD PhD         
Hôpital Tenon Not yet recruiting
Paris, France
Contact: Emile Darai, MD PhD         
CH Lyon Sud Not yet recruiting
Pierre-Bénite, France
Contact: François Golfier, MD PhD         
Hôpital de Poissy-Saint-Germain-en-Laye Not yet recruiting
Poissy, France
Contact: Cyrille Huchon, MD PhD         
CHU de Poitiers - Hôpital de la Milétrie Not yet recruiting
Poitiers, France
Contact: Cédric Nadeau, MD         
CHU de Reims - Hôpital Robert Debré Not yet recruiting
Reims, France
Contact: Olivier Graesslin, MD PhD         
CHU de Rennes - Hôpital Sud Recruiting
Rennes, France
Contact: Vincent Lavoue, MD PhD         
Institut Universitaire du Cancer de Toulouse Recruiting
Toulouse, France, 31000
Contact: Gwenael Ferron, MD         
Institut de Cancérologie de Lorraine Not yet recruiting
Vandoeuvre les nancy, France, 54500
Contact: Frédéric Marchal, MD         
Centre de Lutte Contre le Cancer Gustave Roussy Not yet recruiting
Villejuif, France
Contact: Sébastien Gouy, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
ARCAGY/ GINECO GROUP
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Investigators
Principal Investigator: Fabrice Lecuru, MD PhD Hôpital Européen Georges-Pompidou

Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03386734     History of Changes
Other Study ID Numbers: N/2016/72
ENGOT-Cx4 ( Other Identifier: ENGOT )
GINECO-CE106 ( Other Identifier: GINECO )
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female