International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 989
- 试验地点
- 106
- 主要终点
- Disease Free Survival (DFS)
研究概览
简要总结
SENTICOL III is large prospective multicenter international randomized study designed to validate the Sentinel Lymph Node (SLN) mapping technique in early cervical cancer. This "validation study" will compare the outcome of patients with negative SLN (experimental arm) vs patients with negative SLN + Pelvic Lymph Node dissection (PLN)(reference arm).
There will be a "quality assurance" program which will be developed in participating centers with detailed requirements in terms of surgeons' qualifications, pathology qualification, SLN ultrastaging, standardization of the procedure, etc. as well as respect of the "safety algorithm".
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Patient must be ≥ 18 years old, I
- •With squamous or adenocarcinoma or adenosquamous carcinoma of the cervix (proven by biopsy or cone biopsy), I
- •Stage Ia1 with lymphovascular emboli, Ia2, Ib1 IIa1, Ib2 (clinical stage) of the 2018 FIGO classification (see appendix 1), I
- •Maximum diameter ≤ 40 mm by clinical examination and/or magnetic resonance imaging (MRI), I
- •No suspicious node on pelvic MRI with an exploration up to the left renal vein (according to RECIST 1.1), I
- •ECOG performance status 0-2 (see appendix 2), I
- •Signed informed consent and ability to comply with follow-up, I
- •French subjects: in France, a subject will be eligible for inclusion in this study only if either affiliated to, or a beneficiary of, a social security category.
排除标准
- •Pregnancy, E
- •Previous pelvic or abdominal cancer, E
- •Previous chemotherapy and/or radiation therapy for the cervical cancer (previous brachytherapy is accepted), E
- •Proven allergy to blue dye, isotope or indocyanine green (ICG) E
- •Other malignancy within the last 5 years except for treated cancer free of disease and treatment, E
- •Patients with synchronous cancer
研究组 & 干预措施
SLN biopsy only
Sentinel lymph node (SLN) biopsy only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.
干预措施: SLN biopsy only (Procedure)
SLN biopsy + PLN dissection
SLN biopsy + full pelvic lymph node dissection (PLN) will be performed. The radical hysterectomy or trachelectomy will be done.
干预措施: SLN biopsy + PLN dissection (Procedure)
结局指标
主要结局
Disease Free Survival (DFS)
时间窗: Year 3
Composite outcome: the time interval between randomization and recurrence (local/distant) or second cancer or death (all causes), whichever occurs first. This time interval will be analysed concomitantly with HR-QoL scores as a composite outcome.
Health-related quality of life (HR-QoL)
时间窗: Year 3
Composite outcome: significant deterioration will specifically be assessed through 3 targeted dimensions (pain score, global health score and physical functioning scores) in EORTC QLQ-C30 and QLQ-CX24 questionnaires. These scores will be analysed concomitantly with DFS as a composite outcome.
次要结局
未报告次要终点