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

Centre Oscar Lambret

Status and phase: Active, not recruiting; Phase 3

Conditions: Endometrial Carcinoma

Treatments: Drug: Intra-operative SN mapping with patent V blue dye; Drug: Intra-operative SN mapping with indocyanin green; Procedure: Full bilateral laparoscopic lymphadenectomy and Hysterectomy; Procedure: Current initial staging protocols; Drug: Pre-operative SN mapping with radionucleide

Study type: Interventional

Funder types: Other

Identifiers

NCT02598219

SENTIRAD-1502

Details and patient eligibility

About

The aim of this study 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).

Full 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.

Enrollment: 262 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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262 participants in 2 patient groups

Pre-operative SN mapping with radionucleide

Experimental group

Description:

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

Treatment:

Drug: Pre-operative SN mapping with radionucleide

Procedure: Full bilateral laparoscopic lymphadenectomy and Hysterectomy

Drug: Intra-operative SN mapping with indocyanin green

Drug: Intra-operative SN mapping with patent V blue dye

B : Current initial staging protocols

Other group

Description:

Current initial staging protocols

Treatment:

Procedure: Current initial staging protocols