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

NCT ID: NCT02598219

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2027-10-31

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).

Detailed Description

1. 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.

2. Tumor board: The completed chart will be reviewed to confirm the risk group and indication.

3. Complete physical and gynecological examination by surgical oncologist followed by a consultation of anesthesiology to confirm the operability of patient.

4. Informed and signed consent form.

5. Study baseline assessment.

Then,

6. 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)

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

Conditions

Non Endometrioid Carcinoma; Endometrioid Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pre-operative SN mapping with radionucleide

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

Group Type: EXPERIMENTAL

Pre-operative SN mapping with radionucleide

Intervention Type: DRUG

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.

Intra-operative SN mapping with patent V blue dye

Intervention Type: DRUG

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

Intra-operative SN mapping with indocyanin green

Intervention Type: 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

Full bilateral laparoscopic lymphadenectomy and Hysterectomy

Intervention Type: PROCEDURE

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

B : Current initial staging protocols

Current initial staging protocols

Group Type: OTHER

Current initial staging protocols

Intervention Type: PROCEDURE

Current French initial staging protocols

Interventions

Pre-operative SN mapping with radionucleide

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.

Intervention Type: DRUG

Intra-operative SN mapping with patent V blue dye

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

Intervention Type: DRUG

Intra-operative SN mapping with indocyanin green

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

Intervention Type: DRUG

Full bilateral laparoscopic lymphadenectomy and Hysterectomy

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

Intervention Type: PROCEDURE

Current initial staging protocols

Current French initial staging protocols

Intervention Type: PROCEDURE

Other Intervention Names

Pre-operative Sentinel Node; Intra-operative SN mapping; Intra-operative Sentinel Node (SN) mapping with Infracyanine; Full bilateral lymphadenectomy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, France

OTHER_GOV

Sponsor Role: collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Canceropôle Nord Ouest

OTHER

Sponsor Role: collaborator

Centre Oscar Lambret

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lucie BRESSON, MD

Role: STUDY_DIRECTOR

Centre Oscar Lambret

Locations

Polyclinique Urbain V

Avignon, , France

Centre Hospitalier Régional Universitaire

Besançon, , France

Institut Bergonié

Bordeaux, , France

Centre Jean Perrin

Clermont-Ferrand, , France

Centre Georges François Leclerc

Dijon, , France

Centre Oscar Lambret

Lille, , France

Hôpital Jeanne de Flandres, CHRU Lille

Lille, , France

Hôpital Mère-Enfant, CHU Limoges

Limoges, , France

Centre Léon Bérard

Lyon, , France

Institut Paoli Calmettes

Marseille, , France

ICM Val d'Aurelle

Montpellier, , France

Hôpital La Pitié-Salpêtrière

Paris, , France

Hôpital Européen Georges Pompidou

Paris, , France

Institut de Cancérologie de l'Ouest, René Gauducheau

Saint-Herblain, , France

Centre Paul Strauss

Strasbourg, , France

Institut Claudius Regaud

Toulouse, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 34195683 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/34195683/

Results of proteomics profiling of sentinel lymph nodes

Other Identifiers

SENTIRAD-1502

Identifier Type: -

Identifier Source: org_study_id