NCT02598219

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-11-01
• Primary completion: 2024-10-01
• Completion: 2027-10-01
• First posted: 2015-11-05
• Last updated: 2026-03-18

Locations

16 sites across 1 country: France