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

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).

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.

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