Clinical trial · Interventional
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
NCT02598219CI-TRIAL-00105854SENTIRADcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrioid Carcinoma | Endometrioid Adenocarcinoma | ALIAS | 0.90 |
| Non Endometrioid Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Current initial staging protocols | Procedure | — | UNRESOLVED |
| Full bilateral laparoscopic lymphadenectomy and Hysterectomy | Procedure | — | UNRESOLVED |
| Intra-operative SN mapping with indocyanin green | Drug | — | UNRESOLVED |
| Intra-operative SN mapping with patent V blue dye | Drug | — | UNRESOLVED |
| Pre-operative SN mapping with radionucleide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pre-operative SN mapping with radionucleide
- description
- 1 Pre-operative Sentinel Node (SN) mapping with Nanocis or Nanocoll or Rotop-nanoHSA 2- Intra-operative SN mapping with patent V blue dye, or Intra-operative SN mapping with indocyanin green for patients with known hypersensitivity, allergy to patent V blue dye 3- Full bilateral laparoscopic lymphadenectomy and Hysterectomy: If bilateral SN are detected, all positive SN are removed, then the surgeon proceeds to a total hysterectomy. If unilateral SN are detected, surgeon will complete intervention with pelvic LN dissection on the opposite side, in accordance with risk group definition (ex: omentectomy for high-risk non endometrioid carcinomas). If non SN are detected, surgeon will proceed to a total hysterectomy, a bilateral salpingo-oophorectomy, a complete and bilateral pelvic LND with more enlarged dissection regardless the pathology
- interventionNames
- Drug: Pre-operative SN mapping with radionucleide
- Drug: Intra-operative SN mapping with patent V blue dye
- Drug: Intra-operative SN mapping with indocyanin green
- Procedure: Full bilateral laparoscopic lymphadenectomy and Hysterectomy
- type
- OTHER
- label
- B : Current initial staging protocols
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTAboulouard S, Wisztorski M, Duhamel M, Saudemont P, Cardon T, Narducci F, Lemaire AS, Kobeissy F, Leblanc E, Fournier I, Salzet M. In-depth proteomics analysis of sentinel lymph nodes from individuals with endometrial cancer. Cell Rep Med. 2021 Jun 15;2(6):100318. doi: 10.1016/j.xcrm.2021.100318. eCollection 2021 Jun 15. PMID 34195683