HUMAN ALBUMIN SOLUTION for Endometrial cancer | Intermediate-risk endometrial cancer | High-risk endometrial cancer

Stratification factors

• Recurrence risk strata: Intermediate-risk endometrioid (Strata A)
• Recurrence risk strata: High-risk endometrioid (Strata B)
• Recurrence risk strata: High-risk non-endometrioid (Strata C)

Inclusion criteria

• {"criterion_text":"- 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 ESMO guidelines: • Strata A - Intermediate-risk endometrioid (type 1): 2009 FIGO stage IA/T1a grade 3, or IB grade 1 or 2 Or • Strata B - High risk endometrioid (type 1): 2009 FIGO stages IB/T1b, grade 3. FIGO stage II, grade 1 or 2 or 3. Or • Strata C - High risk non endometrioid (type 2): 2009 FIGO stages I-II\n- Without any suspicious pelvic, paraaortic, distant node at preoperative MRI (lombo-pelvic MRI or pelvic MRI associated with whole body scintigraphy)\n- Age ≥ 18 years\n- Performance status (OMS) ≤ 2\n- No contraindication to surgery\n- Absence of known hypersensitivity: • to colloidal rhenium sulphide and technecium (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\n- Signed and dated informed consent\n- Effective contraception for patients with reproductive potential\n- Patient affiliated with a health insurance system"}

Exclusion criteria

• {"criterion_text":"- 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 at preoperative workup - Suspicious adenopathy at preoperative workup\n- Pregnant and/or breastfeeding woman\n- No understanding of the trial\n- Patient deprived of liberty or in guardianship\n- Inexperience of the trial site in pelvic sentinel node detection"}

Primary endpoints

• {"endpoint_text":"- Per-operative morbidity will be assessed during surgery according to the Oslo classification of intraoperative unfavourable incidents. Adverse effects possibly related to node dissection will be assessed at per-operative timepoint, in particular: - vascular (including blood loss) - urinary - digestive - and nervous system related disorders","definition_or_measurement_approach":"Assessed during surgery according to the Oslo classification of intraoperative unfavourable incidents; adverse effects possibly related to node dissection recorded by system (vascular, urinary, digestive, nervous)."}
• {"endpoint_text":"- Early post-operative morbidity possibly related to node dissection will be assessed up to 30 days and scored according to Clavien-Dindo scale: - post-operative complications (vascular, urinary, digestive, nervous complications), - symptomatic lymphocysts (necessitating pain killers or punctions) and leg lymphedemas whatever the intensity and duration (preoperative and postoperative legs and thigh measurements. Post-operative events of grade II or more defined by Clavien-Dindo scale","definition_or_measurement_approach":"Assessed up to 30 days post-op and scored by Clavien-Dindo scale; includes vascular, urinary, digestive, neurologic complications, symptomatic lymphocysts (requiring analgesics or puncture) and leg lymphedemas (pre- and post-op limb measurements). Events of grade II or more counted."}
• {"endpoint_text":"- Distant complications, beyond day 30 for patients (e.g. secondary paraaortic dissection for pelvic pN1) will be evaluated in accordance with the NCI-CTCAE scale v4.03, until third year of post-operative follow-up. Adverse effects related to node dissection will be searched for, especially: - nervous complications (obturator, femoral nerves) - lymphatic (lymphocyst, leg lymphedema, erysipelas) complications. Concerning lymphocyst, only symptomatic lymphocysts (pain, fever...)","definition_or_measurement_approach":"Assessed beyond day 30 up to 3 years post-op using NCI-CTCAE v4.03; specifically monitoring nervous and lymphatic complications; only symptomatic lymphocysts considered."}

Secondary endpoints

• {"endpoint_text":"- In the experimental arm (SN policy), the overall detection rate of pelvic SN (uni- or bilateral) is calculated as the number of patients with at least one SN detected per-operatively, divided by the total number of patients who underwent staging in the experimental arm. Bilateral detection rate is calculated as number of patients with bilateral SN divided by the total number of patients who underwent staging.","definition_or_measurement_approach":"Overall and bilateral detection rates calculated as described: number with ≥1 SN detected / total staged; bilateral = number with bilateral SN / total staged."}
• {"endpoint_text":"- SN-positive detection rate is calculated as number of detected SN divided by the total number of lymph nodes extracted","definition_or_measurement_approach":"Calculated as number of detected SN that are positive divided by total number of lymph nodes extracted."}
• {"endpoint_text":"- The disease free survival is defined as the time from the date of randomization to the first documentation of local, regional or distant relapse or all-cause death, whichever occurs first. Observations will be censored at the date of last follow-up for patients alive free of disease at last follow-up.","definition_or_measurement_approach":"Time from randomization to first documented relapse (local/regional/distant) or all-cause death; censor at last follow-up if alive and disease-free."}
• {"endpoint_text":"- The overall survival is defined as the time from the date of randomization to the date of all-cause death. Observations will be censored at the date of last follow-up for patients still alive. The specific survival is defined as the time from the date of randomization to the date of death from cancer. Observations will be censored at the date of death for patients who died from another cause, and at the date of last follow-up for patients still alive.","definition_or_measurement_approach":"Overall survival: time from randomization to death from any cause; specific survival: time from randomization to death from cancer; censoring rules as stated."}
• {"endpoint_text":"- Exploratory : standard staining with HES (hematoxylin-eosin-safran) is carried out in a systematic manner as well as immunohistochemistry with polyclonal anti-L1CAM: clone CD171 (SIGMA). The rate of L1CAM positive sample must be precised in the final pathology report, to be further correlated with the node involvement and disease recurrence.","definition_or_measurement_approach":"Exploratory IHC staining for L1CAM on uterine specimens; rate of L1CAM-positive samples reported and correlated with node involvement and recurrence."}
• {"endpoint_text":"- Exploratory: Standard sections of SN, with IHC staining or not, are required for mass spectrometry analysis. For each tissue, 7 superfrost slides are needed with 2 or 3 sections by glass slide (depending to the size of the tissue). All SN slides must be stored by the investigational site until their transfer to PRISM laboratory. During the study, the sponsor will draft the list of samples to be analyzed, and will organize shipment of slides from the investigational site, to the PRISM laboratory.","definition_or_measurement_approach":"Exploratory proteomic analysis of sentinel node tissue via mass spectrometry; standard sectioning requirements and sample storage/transfer procedures specified."}

Other endpoints

• {"endpoint_text":"- Exploratory : standard staining with HES (hematoxylin-eosin-safran) is carried out in a systematic manner as well as immunohistochemistry with polyclonal anti-L1CAM: clone CD171 (SIGMA). The rate of L1CAM positive sample must be precised in the final pathology report, to be further correlated with the node involvement and disease recurrence.","definition_or_measurement_approach":"IHC with anti-L1CAM; rate of L1CAM positive samples to be reported and correlated with node involvement and recurrence."}
• {"endpoint_text":"- Exploratory: Standard sections of SN, with IHC staining or not, are required for mass spectrometry analysis. For each tissue, 7 superfrost slides are needed with 2 or 3 sections by glass slide (depending to the size of the tissue). All SN slides must be stored by the investigational site until their transfer to PRISM laboratory. During the study, the sponsor will draft the list of samples to be analyzed, and will organize shipment of slides from the investigational site, to the PRISM laboratory.","definition_or_measurement_approach":"Mass spectrometry (proteomic) analysis on SN sections with specified slide preparation and storage; sponsor-organized sample selection and shipment to PRISM laboratory."}

France

Earliest CTIS Part Ii Submission Date

12-04-2024

Latest Decision Or Authorization Date

15-01-2026

Processing Time Days

643

Number Of Sites

15

Number Of Participants

262

Primary sponsor

Full Name

Centre Oscar Lambret

Organisation Type

Pharmaceutical company

Country Of Registered Address

France