Evaluation of Sentinel Node Policy in Early Stage Endometrial Carcinomas at Intermediate and High Risk of Recurrence. (SENTIRAD)
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|ClinicalTrials.gov Identifier: NCT02598219|
Recruitment Status : Active, not recruiting
First Posted : November 5, 2015
Last Update Posted : September 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Carcinoma||Drug: Pre-operative SN mapping with radionucleide 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||Phase 3|
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.
- Tumor board: The completed chart will be reviewed to confirm the risk group and indication.
- Complete physical and gynecological examination by surgical oncologist followed by a consultation of anesthesiology to confirm the operability of patient.
- Informed and signed consent form.
Study baseline assessment.
Surgery should be performed within a maximum of 4 weeks from the first consultation, according arm allocated:
Arm A: Sentinel node policy*
- 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)
- Second tumor board: after definitive pathological results of the hysterectomy-annexectomy and node (sentinel or not) specimens.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 2015|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2022|
Experimental: Pre-operative SN mapping with radionucleide
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
Drug: Pre-operative SN mapping with radionucleide
Other Name: Pre-operative Sentinel Node
Drug: Intra-operative SN mapping with patent V blue dye
Other Name: Intra-operative SN mapping
Drug: Intra-operative SN mapping with indocyanin green
1: Infracyanine powder is diluted in aqueous sterile water to obtain 4ml with a concentration of 1.25 mg/mL. Four 1ml syringe, each containing a 1.25 mg/mL Infracyanine dye solution, are prepared per patient.
2- Intracervical injection is performed by the surgeon, after anesthesis induction and incising the skin,under laparoscopic / laparotomy control to detect intraperitoneal injection of the tracer. Sub-mucous injections are performed with 50% diluted dye at 3 and 9 o'clock positions. At each positions : 1ml is injected deep into the stroma of the cervix (1cm), another 1ml is injected superficially (at 2mm depth). The time between the injection of the dye and the search for the SN must be as shortest as possible
3- SN detection by near-infrared fluorescence imaging
Other Name: Intra-operative Sentinel Node (SN) mapping with Infracyanine
Procedure: Full bilateral laparoscopic lymphadenectomy and Hysterectomy
Other Name: Full bilateral lymphadenectomy
B : Current initial staging protocols
Current initial staging protocols
Procedure: Current initial staging protocols
Current French initial staging protocols
- Morbidity [ Time Frame: Up to 3 after surgery ]
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
- Rate of detected sentinel node [ Time Frame: During surgery ]number of patients with ≥ 1 Sentinel Node (SN) / total number of explored patients, and bilaterality
- Rate of pN1 [ Time Frame: an average of 1 month after surgery ]n pN1 / total N
- Disease free survival [ Time Frame: Up to 5 years after surgery ]Time from the date of randomization to the first documentation of local, regional or distant disease or death, whichever occurs first.
- Overall survival [ Time Frame: Up to 5 years after surgery ]Time from the date of randomization to the date of death (indicate if the death is due to disease progression or not).
- Pronostic value of L1CAM on the risk of reccurrence [ Time Frame: an average of 1 month after surgery ]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.
- Proteomic signature of positive SN [ Time Frame: an average of 1 year after surgery ]Detection of SN involvement with proteomics
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02598219
|Polyclinique Urbain V|
|Avignon, France, 84036|
|Centre Hospitalier Régional Universitaire|
|Besançon, France, 25000|
|Bordeaux, France, 33076|
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|Centre Georges François Leclerc|
|Centre Oscar Lambret|
|Lille, France, 59020|
|Hôpital Jeanne de Flandres, CHRU Lille|
|Lille, France, 59037|
|Hôpital Mère-Enfant, CHU Limoges|
|Limoges, France, 87042|
|Centre Léon Bérard|
|Lyon, France, 69008|
|Institut Paoli Calmettes|
|Marseille, France, 13273|
|ICM Val d'Aurelle|
|Montpellier, France, 34298|
|Hôpital La Pitié-Salpêtrière|
|Paris, France, 75013|
|Hôpital Européen Georges Pompidou|
|Paris, France, 75015|
|Paris, France, 75020|
|Institut Jean Godinot|
|Reims, France, 51056|
|Institut de Cancérologie de l'Ouest, René Gauducheau|
|Saint-Herblain, France, 44805|
|Centre Paul Strauss|
|Strasbourg, France, 67065|
|Centre Hospitalier Universitaire|
|Strasbourg, France, 67098|
|Institut Claudius Regaud|
|Toulouse, France, 31059|
|Institut Gustave Roussy|
|Villejuif, France, 94800|
|Study Director:||Eric LEBLANC, MD||Centre Oscar Lambret|
|Study Director:||Hélène GAUTHIER, MD||Centre Oscar Lambret|