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

NCT02598219Active, Not RecruitingPHASE3INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Centre Oscar Lambret

Enrollment

262

Start Date

2015-11-01

Completion Date

2024-10-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Pre-operative SN mapping with radionucleideIntra-operative SN mapping with patent V blue dyeIntra-operative SN mapping with indocyanin greenFull bilateral laparoscopic lymphadenectomy and HysterectomyCurrent initial staging protocols

Conditions

Non Endometrioid CarcinomaEndometrioid Carcinoma

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Morbidity

Per-operative morbidity will be assessed during surgery according to the Oslo classification of intraoperative unfavourable incidents. Early post-operative morbidity will be assessed up to 30 days and scored according to Clavien-Dindo scale. Distant complications, beyond day 30 for patients with no indication of a secondary surgical staging (e.g. secondary paraaortic dissection for pelvic pN1) will be evaluated in accordance with the NCI-CTCAE scale v4.03

Time frame: Up to 3 after surgery

Secondary Outcomes

Rate of detected sentinel node

number of patients with ≥ 1 Sentinel Node (SN) / total number of explored patients, and bilaterality

Time frame: During surgery

Rate of pN1

n pN1 / total N

Time frame: an average of 1 month after surgery

Disease free survival

Time from the date of randomization to the first documentation of local, regional or distant disease or death, whichever occurs first.

Time frame: Up to 5 years after surgery

Overall survival

Time from the date of randomization to the date of death (indicate if the death is due to disease progression or not).

Time frame: Up to 5 years after surgery

Pronostic value of L1CAM on the risk of reccurrence

A standard staining with HES is carried out in a systematic manner as well as immunohistochemistry with polyclonal anti-L1CAM. If 10% or more of the tumor cells showed L1CAM staining, the sample is rated positive. The rate of L1CAM positive sample will be further correlated with the node involvement and disease recurrence.

Time frame: an average of 1 month after surgery

Proteomic signature of positive SN

Detection of SN involvement with proteomics

Time frame: an average of 1 year after surgery

Locations

Polyclinique Urbain V, Avignon, France

Centre Hospitalier Régional Universitaire, Besançon, France

Institut Bergonié, Bordeaux, France

Centre Jean Perrin, Clermont-Ferrand, France

Centre Georges François Leclerc, Dijon, France

Centre Oscar Lambret, Lille, France

Hôpital Jeanne de Flandres, CHRU Lille, Lille, France

Hôpital Mère-Enfant, CHU Limoges, Limoges, France

Centre Léon Bérard, Lyon, France

Institut Paoli Calmettes, Marseille, France

ICM Val d'Aurelle, Montpellier, France

Hôpital La Pitié-Salpêtrière, Paris, France

Hôpital Européen Georges Pompidou, Paris, France

Institut de Cancérologie de l'Ouest, René Gauducheau, Saint-Herblain, France

Centre Paul Strauss, Strasbourg, France

Institut Claudius Regaud, Toulouse, France

Linked Investigators