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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03386734
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : September 24, 2019
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

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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.




Information from the National Library of Medicine

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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
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Contact: Rachida Mama Abdou 0033184852016 rmamaabdou@arcagy.org
Contact: Kristina Mouyabi 0033381218356 kmouyabi@chu-besancon.fr

Locations
Show Show 40 study locations
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
ARCAGY/ GINECO GROUP
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Investigators
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Principal Investigator: Fabrice Lecuru, MD PhD Hôpital Européen Georges-Pompidou
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03386734    
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: September 24, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases