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

Last updated: March 16, 2026
Sponsor: Centre Oscar Lambret
Overall Status: Active - Not Recruiting

Phase

3

Condition

Dysfunctional Uterine Bleeding

Endometrial Cancer

Carcinoma

Treatment

Current initial staging protocols

Pre-operative SN mapping with radionucleide

Full bilateral laparoscopic lymphadenectomy and Hysterectomy

Clinical Study ID

NCT02598219
SENTIRAD-1502
2015-001732-38
2024-513079-42-00
PHRC-K14-184
  • Ages > 18
  • Female

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with early endometrial carcinoma with early FIGO clinical stage I-II (clinical examination, abdomino-pelvic MRI/Ultrasound - or CT scan if MRI notpossible - and endometrial biopsy or curettage), then stratification of therecurrence 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 1or 2 or 3

  • Or High risk non endometrioid (type 2) : FIGO stages I-II

  1. Without any suspicious pelvic, paraaortic, distant node at preoperative MRI

  2. Age ≥ 18 years

  3. Performance status (OMS) ≤ 2

  4. No contraindication to surgery

  5. 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 indocyaninegreen if available) or one of their excipients, to triphenylmethane derivatives

  6. Signed and dated informed consent

  7. Effective contraception for patients with reproductive potential

  8. Patient affiliated with a health insurance system

Exclusion

Exclusion Criteria:

  1. Preoperative workup with :
  • Previous hysterectomy (by nature, this trial cannot be offered as a secondarystaging procedure)

  • non carcinoma (for example sarcoma, trophoblastic tumor)

  • Low-risk endometrioid carcinoma as defined by the ESMO: 2009 FIGO stage IAgrade 1-2

  • Metastatic disease at preoperative workup

  • Suspicious adenopathy at preoperative workup

  1. Pregnant and/or breastfeeding woman

  2. No understanding of the trial

  3. Patient deprived of liberty or in guardianship

  4. Inexperience of the trial site in pelvic sentinel node detection

Study Design

Total Participants: 262
Treatment Group(s): 5
Primary Treatment: Current initial staging protocols
Phase: 3
Study Start date:
November 01, 2015
Estimated Completion Date:
October 31, 2027

Study Description

  1. Routine exams required for diagnosis:

    • Endometrioid biopsy or product of a dilatation-curettage under hysteroscopy for diagnosis of histologic typing

    • Tumor assessment: Lombopelvic MRI (1.5 or 3T) with gadolinium injection, studied by steady and dynamic sequences. US and CT-Scan in case of intolerance to MRI should be discussed. FDG-PET may be an option.

  2. Tumor board: The completed chart will be reviewed to confirm the risk group and indication.

  3. Complete physical and gynecological examination by surgical oncologist followed by a consultation of anesthesiology to confirm the operability of patient.

  4. Informed and signed consent form.

  5. Study baseline assessment.

    Then,

  6. Surgery should be performed within a maximum of 4 weeks from the first consultation, according arm allocated:

    Arm A: Sentinel node policy*

    Arm B:

    • Bilateral pelvic lymphadenectomy (intermediate risk endometrioid)

    • Or Ilio-infrarenal paraaortic lymphadenectomy (high risk endometrioid)

    • Or Pelvic + paraaortic lymphadenectomies (high risk non endometrioid)*

      • along with a peritoneal staging for each arm (cytology, random biopsies, infracolic omentectomy)
  7. Second tumor board: after definitive pathological results of the hysterectomy-annexectomy and node (sentinel or not) specimens.

Connect with a study center

  • Polyclinique Urbain V

    Avignon, 84036
    France

    Site Not Available

  • Polyclinique Urbain V

    Avignon 3035681, 84036
    France

    Site Not Available

  • Centre Hospitalier Régional Universitaire

    Besançon, 25000
    France

    Site Not Available

  • Centre Hospitalier Régional Universitaire

    Besançon 3033123, 25000
    France

    Site Not Available

  • Institut Bergonié

    Bordeaux, 33076
    France

    Site Not Available

  • Institut Bergonié

    Bordeaux 3031582, 33076
    France

    Site Not Available

  • CHU Clermont-Ferrand

    Clermont-Ferrand,
    France

    Site Not Available

  • Centre Jean Perrin

    Clermont-Ferrand, 63011
    France

    Site Not Available

  • Centre Jean Perrin

    Clermont-Ferrand 3024635, 63011
    France

    Site Not Available

  • Centre Georges François Leclerc

    Dijon,
    France

    Site Not Available

  • Centre Georges François Leclerc

    Dijon 3021372,
    France

    Site Not Available

  • Centre Oscar Lambret

    Lille, 59020
    France

    Site Not Available

  • Hôpital Jeanne de Flandres, CHRU Lille

    Lille, 59037
    France

    Site Not Available

  • Centre Oscar Lambret

    Lille 2998324, 59020
    France

    Site Not Available

  • Hôpital Jeanne de Flandres, CHRU Lille

    Lille 2998324, 59037
    France

    Site Not Available

  • Hôpital Mère-Enfant, CHU Limoges

    Limoges, 87042
    France

    Site Not Available

  • Hôpital Mère-Enfant, CHU Limoges

    Limoges 2998286, 87042
    France

    Site Not Available

  • Centre Léon Bérard

    Lyon, 69008
    France

    Site Not Available

  • Centre Léon Bérard

    Lyon 2996944, 69008
    France

    Site Not Available

  • Institut Paoli Calmettes

    Marseille, 13273
    France

    Site Not Available

  • Institut Paoli Calmettes

    Marseille 2995469, 13273
    France

    Site Not Available

  • ICM Val d'Aurelle

    Montpellier, 34298
    France

    Site Not Available

  • ICM Val d'Aurelle

    Montpellier 2992166, 34298
    France

    Site Not Available

  • Institut de Cancérologie de l'Ouest, René Gauducheau

    Nantes Saint-Herblain, 44805
    France

    Site Not Available

  • Hôpital Européen Georges Pompidou

    Paris, 75015
    France

    Site Not Available

  • Hôpital La Pitié-Salpêtrière

    Paris, 75013
    France

    Site Not Available

  • Hôpital Européen Georges Pompidou

    Paris 2988507, 75015
    France

    Site Not Available

  • Hôpital La Pitié-Salpêtrière

    Paris 2988507, 75013
    France

    Site Not Available

  • Institut Jean Godinot

    Reims, 51056
    France

    Site Not Available

  • Institut de Cancérologie de l'Ouest, René Gauducheau

    Saint-Herblain, 44805
    France

    Site Not Available

  • Institut de Cancérologie de l'Ouest, René Gauducheau

    Saint-Herblain 2979590, 44805
    France

    Site Not Available

  • Centre Hospitalier Universitaire

    Strasbourg, 67098
    France

    Site Not Available

  • Centre Paul Strauss

    Strasbourg, 67065
    France

    Site Not Available

  • Centre Paul Strauss

    Strasbourg 2973783, 67065
    France

    Site Not Available

  • Institut Claudius Regaud

    Toulouse, 31059
    France

    Site Not Available

  • Institut Claudius Regaud

    Toulouse 2972315, 31059
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif, 94800
    France

    Site Not Available

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