Randomized Trial 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
- 已完成
- 入组人数
- 262
- 试验地点
- 16
- 主要终点
- Morbidity
研究概览
简要总结
The aim of this trial is to evaluate the sentinel node policy in early stage endometrial carcinomas at intermediate and high risk of recurrence (by comparing the sentinel node policy to current initial staging protocols).
详细描述
- 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.
Then, 6. Surgery should be performed within a maximum of 4 weeks from the first consultation, according arm allocated:
Arm A: Sentinel node policy*
Arm B:
- Bilateral pelvic lymphadenectomy (intermediate risk endometrioid)
- Or Ilio-infrarenal paraaortic lymphadenectomy (high risk endometrioid)
- Or Pelvic + paraaortic lymphadenectomies (high risk non endometrioid)*
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
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 European Society for Medical Oncology (ESMO) guidelines :
- •Intermediate-risk endometrioid (type 1): FIGO stage IA/T1a grade 3, or IB grade 1 or 2
- •Or High risk endometrioid (type 1) : FIGO stage IB/T1b grade 3, or II grade 1 or 2 or 3
- •Or High risk non endometrioid (type 2) : 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 sulphide and technetium (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 example sarcoma, trophoblastic tumor)
- •Low-risk endometrioid carcinoma as defined by the ESMO: 2009 FIGO stage IA grade 1-2
- •Metastatic 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
研究组 & 干预措施
B : Current initial staging protocols
Current initial staging protocols
干预措施: Current initial staging protocols (Procedure)
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
干预措施: Pre-operative SN mapping with radionucleide (Drug)
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
干预措施: Intra-operative SN mapping with patent V blue dye (Drug)
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
干预措施: Intra-operative SN mapping with indocyanin green (Drug)
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
干预措施: Full bilateral laparoscopic lymphadenectomy and Hysterectomy (Procedure)
结局指标
主要结局
Morbidity
时间窗: 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
次要结局
- Rate of detected sentinel node(During surgery)
- Rate of pN1(an average of 1 month after surgery)
- Disease free survival(Up to 5 years after surgery)
- Overall survival(Up to 5 years after surgery)
- Pronostic value of L1CAM on the risk of reccurrence(an average of 1 month after surgery)
- Proteomic signature of positive SN(an average of 1 year after surgery)