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
- Diseases
- Endometrial cancer
- 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
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sainte Catherine Institut Du Cancer Avignon-Provence Coordinator of this site? Confirm its status | Avignon Cedex 9 | France | Completed |
| Besancon University Hospital Center Coordinator of this site? Confirm its status | Besancon Cedex | France | Completed |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Completed |
| Centre Jean Perrin Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Completed |
| Centr Georges Francois Leclerc Coordinator of this site? Confirm its status | Dijon | France | Completed |
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Completed |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Completed |
| Centre Hospitalier Et Universitaire de Limoges Coordinator of this site? Confirm its status | Limoges | France | Completed |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Completed |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Completed |
| Institut Regional Du Cancer De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Completed |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Completed |
| Institut de Cancérologie Strasbourg Europe Coordinator of this site? Confirm its status | Strasbourg | France | Completed |
| Institut Universitaire du Cancer Toulouse - Oncopole Coordinator of this site? Confirm its status | Toulouse | France | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.