Evaluation of Sentinel Node Policy in Early Stage Endometrial Carcinomas at Intermediate and High Risk of Recurrence.
SENTIRAD
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
4 other identifiers
interventional
262
1 country
16
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2015
Longer than P75 for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 3, 2015
CompletedFirst Posted
Study publicly available on registry
November 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
ExpectedMarch 18, 2026
March 1, 2026
8.9 years
November 3, 2015
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Morbidity
Per-operative morbidity will be assessed during surgery according to the Oslo classification of intraoperative unfavourable incidents. Early post-operative morbidity will be assessed up to 30 days and scored according to Clavien-Dindo scale. Distant complications, beyond day 30 for patients with no indication of a secondary surgical staging (e.g. secondary paraaortic dissection for pelvic pN1) will be evaluated in accordance with the NCI-CTCAE scale v4.03
Up to 3 after surgery
Secondary Outcomes (6)
Rate of detected sentinel node
During surgery
Rate of pN1
an average of 1 month after surgery
Disease free survival
Up to 5 years after surgery
Overall survival
Up to 5 years after surgery
Pronostic value of L1CAM on the risk of reccurrence
an average of 1 month after surgery
- +1 more secondary outcomes
Study Arms (2)
Pre-operative SN mapping with radionucleide
EXPERIMENTAL1 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
B : Current initial staging protocols
OTHERCurrent initial staging protocols
Interventions
1. Preparation : four 1ml syringe (Nanocis, or Nanocoll, or Rotop-nanoHSA) are prepared per patient, each containing a total activity 10 MBq if the injection is planned the same day of surgery and in the operative theater OR each containing a total activity 30MBq if the injection is performed the day before the surgery. 2. Intracervical injection is performed by the surgeon, no more than 3-24 hours before surgery : 4 submucous injections with the filtered radiocolloid at 3, 6, 9 and 12 o'clock positions. Each injection if performed at 2 mm of depth for a total activity of 40 MBq or a total activity of 120 MBq is the surgery is planned the day after the injection. 3. Sentinel Node detection by planar scintigraphy at 1 and 3h (if no detection at 1 hour), or by SPECT-CT imaging if available.
1. Patent blue V dye are diluted with saline sterile solution to obtain 4ml of 50%. Four 1ml syringe, each containing a 50% patent blue dye solution, are prepared per patient. 2. Intracervical injection is performed by the surgeon. after anesthesis induction and incising the skin,under laparoscopic / laparotomy control to detect intraperitoneal injection of the tracer. Sub-mucous injections are performed with 50% diluted dye at 3 and 9 o'clock positions. At each positions : 1ml is injected deep into the stroma of the cervix (1cm), another 1ml is injected superficially (at 2mm depth). The time between the injection of the dye and the search for the SN must be as shortest as possible. 3. SN are detected by direct visualization of blue colored lymphatics and node
1: Infracyanine powder is diluted in aqueous sterile water to obtain 4ml with a concentration of 1.25 mg/mL. Four 1ml syringe, each containing a 1.25 mg/mL Infracyanine dye solution, are prepared per patient. 2- Intracervical injection is performed by the surgeon, after anesthesis induction and incising the skin,under laparoscopic / laparotomy control to detect intraperitoneal injection of the tracer. Sub-mucous injections are performed with 50% diluted dye at 3 and 9 o'clock positions. At each positions : 1ml is injected deep into the stroma of the cervix (1cm), another 1ml is injected superficially (at 2mm depth). The time between the injection of the dye and the search for the SN must be as shortest as possible 3- SN detection by near-infrared fluorescence imaging
* Bilateral pelvic lymphadenectomy (intermediate risk endometrioid) * Or Ilio-infrarenal paraaortic lymphadenectomy (high risk endometrioid) * Or Pelvic + paraaortic lymphadenectomies (high risk non endometrioid)
Current French initial staging protocols
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute, Francecollaborator
- Centre Oscar Lambretlead
- Institut National de la Santé Et de la Recherche Médicale, Francecollaborator
- Canceropôle Nord Ouestcollaborator
Study Sites (16)
Polyclinique Urbain V
Avignon, 84036, France
Centre Hospitalier Régional Universitaire
Besançon, 25000, France
Institut Bergonié
Bordeaux, 33076, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Centre Georges François Leclerc
Dijon, France
Centre Oscar Lambret
Lille, 59020, France
Hôpital Jeanne de Flandres, CHRU Lille
Lille, 59037, France
Hôpital Mère-Enfant, CHU Limoges
Limoges, 87042, France
Centre Léon Bérard
Lyon, 69008, France
Institut Paoli Calmettes
Marseille, 13273, France
ICM Val d'Aurelle
Montpellier, 34298, France
Hôpital La Pitié-Salpêtrière
Paris, 75013, France
Hôpital Européen Georges Pompidou
Paris, 75015, France
Institut de Cancérologie de l'Ouest, René Gauducheau
Saint-Herblain, 44805, France
Centre Paul Strauss
Strasbourg, 67065, France
Institut Claudius Regaud
Toulouse, 31059, France
Related Publications (1)
Aboulouard 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: 34195683RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lucie BRESSON, MD
Centre Oscar Lambret
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2015
First Posted
November 5, 2015
Study Start
November 1, 2015
Primary Completion
October 1, 2024
Study Completion (Estimated)
October 1, 2027
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share