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

  • STATUS
    Recruiting
  • End date
    May 24, 2026
  • participants needed
    950
  • sponsor
    Centre Hospitalier Universitaire de Besancon
Updated on 4 October 2022
cancer
hysterectomy
lymphadenectomy
adenocarcinoma
cervical adenocarcinoma
iia1

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".

Details
Condition Cervical Cancer
Treatment SLN biopsy only, SLN biopsy + PLN dissection
Clinical Study IdentifierNCT03386734
SponsorCentre Hospitalier Universitaire de Besancon
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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)
Clear my responses

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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