Intermediate-risk endometrioïd carcinomas : IAg3, IB(II)g1-2 High-risk endometrioïd carcinomas : IB-II g3 High-risk non endometrioïd carcinomas : I-II MedDRA version: 18.0 Level: PT Classification code 10014733 Term: Endometrial cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: NANOCIS
Product Name: NANOCIS
Pharmaceutical Form: Powder and solution for solution for injection
Trade Name: PATENT BLUE V
Product Name: PATENT BLUE V
Pharmaceutical Form: Solution for i
Sponsors
CENTRE OSCAR LAMBRET
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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 ESMO : => Intermediate-risk endometrioid (type 1): 2009 FIGO stage IA grade 3, or IB-II grade 1 or 2 OR => High risk endometrioid (type 1): 2009 FIGO stage IB or II, grade 3 OR => High risk non endometrioid (type 2): 2009 FIGO stages I-II - Without any suspicious pelvic, paraaortic, distant node at preoperative MRI - Age = 18 years - Performance status (OMS) = 2 - No contraindication to surgery - Absence of known hypersensitivity to colloidal rhenium suplphide and technecium (nanocolloid) or one of its excipients, to injectable dyes (blue dye or indocyanine green if available) or one of their excipients, to triphenylmethane derivatives - Signed and dated informed consent - Effective contraception for patients with reproductive potential - Patient affiliated with a health insurance system Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 240
Exclusion criteria
Exclusion criteria: - Preoperative workup with: - Previous hysterectomy (by nature, this trial cannot be offered as a secondary staging procedure) - non carcinoma (for exemple sarcoma, trophoblastic tumor) - Low-risk endometrioïd carcinoma as defined by ESMO : 2009 FIGO stage IA grade 1-2 - Metastastic disease - Suspicious adenopathy at preoperative workup - Pregnant and/or breastfeeding woman - No comprehension of the trial - Patient deprived of liberty or in guardianship - Inexperience in pelvic sentinel node detection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Morbidity of a sentinel node policy (exclusive SN resection vs complete lymphadenectomy on SN-negative side) versus the national or European protocols of surgical staging in intermediate-risk endometrioid and high-risk endometrioid and non-endometrioid carcinomas ;Secondary Objective: - Rate of sentinel node detection - Rate of positive node detection (pN1) - Disease free survival - Specific and Overall survival - L1CAM (L1 cell adhesion molecule) on uterine specimens as a marker of recurrence and/ or node involvement - Proteomic diagnosis of node metastases;Primary end point(s): Specific morbidity will be assessed through the rate of : - Intraoperative complications (vascular, urinary, digestive). - Postoperative complications, scored according to Clavien-Dindo. - Distant complications, evaluated according to NCI-CTCAE v4.0;Timepoint(s) of evaluation of this end point: - Intraoperative complications : during the surgery. - Postoperative complications : up to 30 days. - Distant complications : beyond 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Rate of detected sentinel node: n patient with = 1 SN / total number of explored patients, and bilaterality - Rate of pN1: n pN1 / total N - Disease free survival - Overall survival - L1CAM expression by IHC on uterine specimens and correlation with node involvement and recurrence - Detection of node involvement with proteomics ;Timepoint(s) of evaluation of this end point: - Rate of detected sentinel node, rate of pN1 : at day of the 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 - Overall survival: time from the date of randomization to date of death - L1CAM expression : at day of the surgery - Detection of node involvement with proteomics : at day of the surgery | — |
Countries
France
Contacts
Public ContactProject Manager
CENTRE OSCAR LAMBRET
Outcome results
None listed