E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Intermediate-risk endometrioïd carcinomas : IAg3, IB(II)g1-2
High-risk endometrioïd carcinomas : IB-II g3
High-risk non endometrioïd carcinomas : I-II
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E.1.1.1 | Medical condition in easily understood language |
Intermediate-risk, high risk endometrial cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10014733 |
E.1.2 | Term | Endometrial cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- 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
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E.2.2 | Secondary objectives of the trial |
- 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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
- Intraoperative complications : during the surgery.
- Postoperative complications : up to 30 days.
- Distant complications : beyond 30 days |
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E.5.2 | 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
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E.5.2.1 | 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 13 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |