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ACTIVE NOT RECRUITING
NCT02598219
PHASE3

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

Sponsor: Centre Oscar Lambret

View on ClinicalTrials.gov

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).

Official 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

262

Start Date

2015-11

Completion Date

2027-10

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

DRUG

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.

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

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

PROCEDURE

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)

PROCEDURE

Current initial staging protocols

Current French initial staging protocols

Locations (16)

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