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

• Status: Active, not recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Oscar Lambret
• Collaborators: Canceropôle Nord Ouest; Institut National de la Santé Et de la Recherche Médicale, France; National Cancer Institute, France

Criteria

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