SENTIRAD-1502 - 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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 262
- 试验地点
- 14
- 主要终点
- 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
研究概览
简要总结
To compare the morbidity classified as possibly related to lymph node dissection between the a sentinel node policy (exclusive SN resection complete pelvic lymphadenectomy on SN-negative side) and the national or European protocols of surgical staging, until 3 years of surgery, in intermediate-risk endometrioid and high-risk endometrioid and non-endometrioid carcinomas (full lymphadenectomy: pelvic, paraaortic or both according to stratification)
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
- •FIGO stage II, grade 1 or 2 or
- •Or • Strata C - High risk non endometrioid (type 2): 2009 FIGO stages I-II
- •Without any suspicious pelvic, paraaortic, distant node at preoperative MRI (lombo-pelvic MRI or pelvic MRI associated with whole body scintigraphy)
- •Age ≥ 18 years
- •Performance status (OMS) ≤ 2
- •No contraindication to surgery
- •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
- •Signed and dated informed consent
- •Effective contraception for patients with reproductive potential
- •Patient affiliated with a health insurance system
排除标准
- •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
- •Pregnant and/or breastfeeding woman
- •No understanding of the trial
- •Patient deprived of liberty or in guardianship
- •Inexperience of the trial site in pelvic sentinel node detection
结局指标
主要结局
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
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
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
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
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...)
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...)
次要结局
- 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.
- SN-positive detection rate is calculated as number of detected SN divided by the total number of lymph nodes extracted
- 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.
- 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.
- 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.
- 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.
研究者
Clinical Research Sponsor Unit
Scientific
Centre Oscar Lambret