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NCT Number: NCT02598219

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Non Endometrioid Carcinoma Adenocarcinoma Adnexal Diseases Carcinoma Carcinoma, Endometrioid Endocrine System Diseases Endometrial Neoplasms Endometrioid Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Polyclinique Urbain V, Avignon, France

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About this study

  • 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.
  • Tumor board: The completed chart will be reviewed to confirm the risk group and indication.
  • Complete physical and gynecological examination by surgical oncologist followed by a consultation of anesthesiology to confirm the operability of patient.
  • Informed and signed consent form.
  • Study baseline assessment.

Then,

  • 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)
  • Second tumor board: after definitive pathological results of the hysterectomy-annexectomy and node (sentinel or not) specimens.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Pre-operative SN mapping with radionucleide

Drug
  • 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.
  • 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.
  • Sentinel Node detection by planar scintigraphy at 1 and 3h (if no detection at 1 hour), or by SPECT-CT imaging if available.

Other names: Pre-operative Sentinel Node

Intra-operative SN mapping with patent V blue dye

Drug
  • 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.
  • 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.
  • SN are detected by direct visualization of blue colored lymphatics and node

Other names: Intra-operative SN mapping

Intra-operative SN mapping with indocyanin green

Drug

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

Other names: Intra-operative Sentinel Node (SN) mapping with Infracyanine

Full bilateral laparoscopic lymphadenectomy and Hysterectomy

Procedure
  • Bilateral pelvic lymphadenectomy (intermediate risk endometrioid)
  • Or Ilio-infrarenal paraaortic lymphadenectomy (high risk endometrioid)
  • Or Pelvic + paraaortic lymphadenectomies (high risk non endometrioid)

Other names: Full bilateral lymphadenectomy

Current initial staging protocols

Procedure

Current French initial staging protocols

Primary outcomes

  1. Morbidity

    Time frame: Up to 3 after surgery

    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

Secondary outcomes

  1. Rate of detected sentinel node

    Time frame: During surgery

    number of patients with ≥ 1 Sentinel Node (SN) / total number of explored patients, and bilaterality

  2. Rate of pN1

    Time frame: an average of 1 month after surgery

    n pN1 / total N

  3. Disease free survival

    Time frame: Up to 5 years after surgery

    Time from the date of randomization to the first documentation of local, regional or distant disease or death, whichever occurs first.

  4. Overall survival

    Time frame: Up to 5 years after surgery

    Time from the date of randomization to the date of death (indicate if the death is due to disease progression or not).

  5. Pronostic value of L1CAM on the risk of reccurrence

    Time frame: an average of 1 month after surgery

    A standard staining with HES is carried out in a systematic manner as well as immunohistochemistry with polyclonal anti-L1CAM. If 10% or more of the tumor cells showed L1CAM staining, the sample is rated positive. The rate of L1CAM positive sample will be further correlated with the node involvement and disease recurrence.

  6. Proteomic signature of positive SN

    Time frame: an average of 1 year after surgery

    Detection of SN involvement with proteomics

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

  • Canceropôle Nord Ouest
  • Institut National de la Santé Et de la Recherche Médicale, France
  • National Cancer Institute, France

Registry information

Official study title

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

Acronym: SENTIRAD

Important dates

Study start
2015
Primary completion
2024
Study completion
2027
First posted
Nov 5, 2015
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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