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Less invasive staging for endometrial cancer put to the test

NCT ID NCT02598219

Knowledge-focused Sponsor: Centre Oscar Lambret Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 16, 2026 · Updated 3 times

Summary

This phase 3 trial compares a less invasive sentinel node biopsy approach to standard staging methods in 262 women with early-stage endometrial cancer at intermediate or high risk of recurrence. The goal is to see if the sentinel node policy reduces surgical complications while still accurately detecting cancer spread. Participants receive a radioactive tracer injection into the cervix before surgery to map the first lymph nodes the cancer might reach.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pre-operative sentinel node mapping with radionucleide (Nanocis, Nanocoll, or Rotop-nanoHSA)
What this could lead to
If successful, this could show that sentinel node biopsy is safer and equally effective as standard staging for certain endometrial cancers, potentially becoming the new standard of care.
What could go wrong
This is a phase 3 trial, but results are not yet available. The approach may not detect all cancer spread, and individual outcomes may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

262 people

The number who actually took part.

Started

Nov 2015

Finished

Aug 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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 2. Without any suspicious pelvic, paraaortic, distant node at preoperative MRI 3. Age ≥ 18 years 4. Performance status (OMS) ≤ 2 5. No contraindication to surgery 6. 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 7. Signed and dated informed consent 8. Effective contraception for patients with reproductive potential 9. Patient affiliated with a health insurance system Exclusion Criteria: 1. 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 2. Pregnant and/or breastfeeding woman 3. No understanding of the trial 4. Patient deprived of liberty or in guardianship 5. Inexperience of the trial site in pelvic sentinel node detection

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Conditions

The condition(s) this trial relates to.

Carcinoma, Endometrioid endometrial carcinoma endometrioid adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endometrioid carcinoma Non endometrioid carcinoma

Contacts and locations

Locations

  • Centre Georges François Leclerc

    Dijon, France

  • Centre Hospitalier Régional Universitaire

    Besançon, 25000, France

  • Centre Jean Perrin

    Clermont-Ferrand, 63011, France

  • Centre Léon Bérard

    Lyon, 69008, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Centre Paul Strauss

    Strasbourg, 67065, France

  • Hôpital Européen Georges Pompidou

    Paris, 75015, France

  • Hôpital Jeanne de Flandres, CHRU Lille

    Lille, 59037, France

  • Hôpital La Pitié-Salpêtrière

    Paris, 75013, France

  • Hôpital Mère-Enfant, CHU Limoges

    Limoges, 87042, France

  • ICM Val d'Aurelle

    Montpellier, 34298, France

  • Institut Bergonié

    Bordeaux, 33076, France

  • Institut Claudius Regaud

    Toulouse, 31059, France

  • Institut Paoli Calmettes

    Marseille, 13273, France

  • Institut de Cancérologie de l'Ouest, René Gauducheau

    Saint-Herblain, 44805, France

  • Polyclinique Urbain V

    Avignon, 84036, France

More trials for these conditions

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