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

Endometrial Carcinoma Clinical Trial

Official title: Randomized Study 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

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Carcinoma
• Endometrial Carcinoma
• Endometrial Neoplasms
• Recurrence

• NCT number: NCT02598219
• Study type: Interventional
• Source: Centre Oscar Lambret
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 2015
• Completion date: October 2027