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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

262

Participants

Timeline

Start Date

November 30, 2015

Primary Completion Date

October 31, 2024

Study Completion Date

October 31, 2027

Conditions
Endometrial Carcinoma
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

Trial Locations (16)

13273

Institut Paoli Calmettes, Marseille

25000

Centre Hospitalier Régional Universitaire, Besançon

31059

Institut Claudius Regaud, Toulouse

33076

Institut Bergonié, Bordeaux

34298

ICM Val d'Aurelle, Montpellier

44805

Institut de Cancérologie de l'Ouest, René Gauducheau, Saint-Herblain

59020

Centre Oscar Lambret, Lille

59037

Hôpital Jeanne de Flandres, CHRU Lille, Lille

63011

Centre Jean Perrin, Clermont-Ferrand

67065

Centre Paul Strauss, Strasbourg

69008

Centre Léon Bérard, Lyon

75013

Hôpital La Pitié-Salpêtrière, Paris

75015

Hôpital Européen Georges Pompidou, Paris

84036

Polyclinique Urbain V, Avignon

87042

Hôpital Mère-Enfant, CHU Limoges, Limoges

Unknown

Centre Georges François Leclerc, Dijon

All Listed Sponsors
collaborator

National Cancer Institute, France

OTHER_GOV

collaborator

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

OTHER_GOV

collaborator

Canceropôle Nord Ouest

OTHER

lead

Centre Oscar Lambret

OTHER