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NCT02598219CompletedPhase 3

Evaluation of Sentinel Node Policy in Early Stage Endometrial Carcinomas at Intermediate and High Risk of Recurrence.

Randomized Trial Comparing Sentinel Node (SN) Policy to Current French Initial Staging Protocols in Early Stage Endometrial Carcinomas at Intermediate and High Risk of Recurrence

Source: ClinicalTrials.gov · Last updated 15 Sept 2026

Brief summary (registry, in English)

The aim of this trial is to evaluate the sentinel node policy in early stage endometrial carcinomas at intermediate and high risk of recurrence (by comparing the sentinel node policy to current initial staging protocols).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
262 (actual)
First submitted
3 Nov 2015
Start date
19 Nov 2015
Primary completion date
20 Sept 2024
Lead sponsor
Centre Oscar Lambret
NCT number
NCT02598219
EU CT number
2024-513079-42-00
EudraCT number
2015-001732-38

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 262
  • From 19 Nov 2015 to the primary completion date, 20 Sept 2024
  • 14 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Preoperative workup with :
    • Previous hysterectomy (by nature, this trial cannot be offered as a secondary staging procedure)
    • non carcinoma (for example sarcoma, trophoblastic tumor)
    • Low-risk endometrioid carcinoma as defined by the ESMO: 2009 FIGO stage IA grade 1-2
    • Metastatic disease at preoperative workup
    • Suspicious adenopathy at preoperative workup

Other

  • Pregnant and/or breastfeeding woman
  • No understanding of the trial
  • Patient deprived of liberty or in guardianship
  • Inexperience of the trial site in pelvic sentinel node detection

Who the study is looking for

  • Patients with early endometrial carcinoma with early FIGO clinical stage I-II (clinical examination, abdomino-pelvic MRI/Ultrasound - or CT scan if MRI not possible - and endometrial biopsy or curettage), then stratification of the recurrence risk as defined by last European Society for Medical Oncology (ESMO) guidelines :
    • Intermediate-risk endometrioid (type 1): FIGO stage IA/T1a grade 3, or IB grade 1 or 2
    • Or High risk endometrioid (type 1) : FIGO stage IB/T1b grade 3, or II grade 1 or 2 or 3
    • Or High risk non endometrioid (type 2) : FIGO stages I-II
  • Without any suspicious pelvic, paraaortic, distant node at preoperative MRI
  • Age ≥ 18 years
  • Performance status (OMS) ≤ 2
  • No contraindication to surgery
  • Absence of known hypersensitivity to colloidal rhenium sulphide and technetium (nanocolloid) or one of its excipients, to human albumin preparations, to Nanocoll® and Rotop-nanoHSA® and their excipients, to injectable dyes (blue dye or indocyanine green if available) or one of their excipients, to triphenylmethane derivatives
  • Signed and dated informed consent
  • Effective contraception for patients with reproductive potential
  • Patient affiliated with a health insurance system

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sainte Catherine Institut Du Cancer Avignon-Provence
Coordinator of this site? Confirm its status
Avignon Cedex 9FranceCompleted
Besancon University Hospital Center
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Besancon CedexFranceCompleted
Institut Bergonie
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BordeauxFranceCompleted
Centre Jean Perrin
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Clermont-FerrandFranceCompleted
Centr Georges Francois Leclerc
Coordinator of this site? Confirm its status
DijonFranceCompleted
Centre Oscar Lambret
Coordinator of this site? Confirm its status
LilleFranceCompleted
Centre Hospitalier Universitaire De Lille
Coordinator of this site? Confirm its status
Lille CedexFranceCompleted
Centre Hospitalier Et Universitaire de Limoges
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LimogesFranceCompleted
Centre Leon Berard
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LyonFranceCompleted
Institut Paoli-Calmettes
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MarseilleFranceCompleted
Institut Regional Du Cancer De Montpellier
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Montpellier Cedex 5FranceCompleted
Assistance Publique Hopitaux de Paris
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ParisFranceCompleted
Institut de Cancérologie Strasbourg Europe
Coordinator of this site? Confirm its status
StrasbourgFranceCompleted
Institut Universitaire du Cancer Toulouse - Oncopole
Coordinator of this site? Confirm its status
ToulouseFranceCompleted

This page is information, not medical advice. Discuss any trial with your doctor.