Clinical trial NCT02598219: Evaluation of Sentinel Node Policy in Early Stage Endometrial Carcinomas At Intermediate and High Risk of Recurrence.
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Endometrial Carcinoma
Keywords: Sentinel node
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
name: Institut National de la Santé Et de la Recherche Médicale, France
name: Canceropôle Nord Ouest
First posted: 2015-11-05
Enrollment: 262
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility 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

Primary outcomes:
measure: Morbidity
timeFrame: Up to 3 after surgery
Secondary outcomes:
measure: Rate of detected sentinel node
timeFrame: During surgery
measure: Rate of pN1
timeFrame: an average of 1 month after surgery
measure: Disease free survival
timeFrame: Up to 5 years after surgery
measure: Overall survival
timeFrame: Up to 5 years after surgery
measure: Pronostic value of L1CAM on the risk of reccurrence
timeFrame: an average of 1 month after surgery
measure: Proteomic signature of positive SN
timeFrame: an average of 1 year after surgery
Other outcomes:
Locations:
city: Avignon
country: France
facility: Polyclinique Urbain V
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire
city: Bordeaux
country: France
facility: Institut Bergonié
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: Hôpital Jeanne de Flandres, CHRU Lille
city: Limoges
country: France
facility: Hôpital Mère-Enfant, CHU Limoges
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: ICM Val d'Aurelle
city: Paris
country: France
facility: Hôpital La Pitié-Salpêtrière
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest, René Gauducheau
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Toulouse
country: France
facility: Institut Claudius Regaud
Study officials:
affiliation: Centre Oscar Lambret
name: Carlos MARTINEZ GOMEZ, MD
role: STUDY_DIRECTOR
References:
citation: Aboulouard S, Wisztorski M, Duhamel M, Saudemont P, Cardon T, Narducci F, Lemaire AS, Kobeissy F, Leblanc E, Fournier I, Salzet M. In-depth proteomics analysis of sentinel lymph nodes from individuals with endometrial cancer. Cell Rep Med. 2021 Jun 15;2(6):100318. doi: 10.1016/j.xcrm.2021.100318. eCollection 2021 Jun 15.