Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, Prague, Czech Republic
Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech Republic.
Int J Gynecol Cancer. 2019 Jan;29(1):212-215. doi: 10.1136/ijgc-2018-000010.
Sentinel lymph node (SLN) biopsy has been increasingly used in the management of early-stage cervical cancer. It appears in guidelines as an alternative option to systematic pelvic lymphadenectomy. The evidence about safety is, however, based mostly on retrospective studies, in which SLN was combined with systematic lymphadenectomy.
SENTIX is a prospective multicenter trial aiming to prove that less-radical surgery with SLN is non-inferior to treatment with systematic pelvic lymphadenectomy. The primary end point is recurrence rate; the secondary end point is the prevalence of lower-leg lymphedema and symptomatic pelvic lymphocele. The reference recurrence rate was set up conservatively at 7% at 24 months after treatment. With a sample size of 300 patients treated per protocol, the trial is powered to detect a non-inferiority margin of 5% (90% power, p = 0.05) for recurrence rate, 30% reduction in the prevalence of symptomatic lymphocele or lower-leg lymphedema, with reference rates of 30% and 6% at 12 months (p = 0.025, Bonferroni correction). The patients eligible for SENTIX have stage IA1/LVSI+, IA2, IB1 (<2 cm for fertility sparing), with negative LN on pre-operative imaging. Intra-operatively, patients are excluded when there is a failure to detect SLN on both sides of the pelvis in cases of more advanced cancer (stage >IB1), or a positive intra-operative SLN assessment. The quality of SLN pathology evaluation will be assessed by central review. Three interim safety analyses are pre-planned when 30, 60, 150 patients complete 12 months' follow-up.
The first patient was enrolled into the study in June 2016 and, by June 2018, 340 patients had been enrolled. The first analysis of secondary outcomes should be available in 2019 and the oncological outcome of 300 patients at the end of 2021. The trial is registered as a CEEGOG trial (CEEGOG CX-01), ENGOT trial (ENGOT-Cx 2), and at the ClinicalTrials.gov database (NCT02494063).
前哨淋巴结（SLN）活检已越来越多地用于早期宫颈癌的治疗。该方法已被写入指南，成为系统盆腔淋巴结清扫术的替代方案。然而，关于安全性的证据主要基于回顾性研究，其中 SLN 与系统淋巴结清扫术联合使用。
SENTIX 是一项前瞻性多中心试验，旨在证明 SLN 少侵犯性手术与系统盆腔淋巴结清扫术同样有效。主要终点是复发率；次要终点是小腿淋巴水肿和有症状的盆腔淋巴囊肿的发生率。参考复发率保守设定为治疗后 24 个月时的 7%。按照方案治疗的 300 例患者的样本量，试验具有检测复发率非劣效性边界 5%（90%的功效，p = 0.05）的能力，症状性淋巴囊肿或小腿淋巴水肿的发生率降低 30%，参考率为 12 个月时的 30%和 6%（p = 0.025，Bonferroni 校正）。符合 SENTIX 标准的患者为 IA1/LVSI+、IA2、IB1 期（保留生育能力的<2cm），术前影像学检查淋巴结阴性。在术中，如果在更晚期癌症（>IB1 期）患者的盆腔两侧均无法检测到 SLN，或术中 SLN 评估阳性，则排除患者。将通过中心审查评估 SLN 病理评估的质量。当 30、60、150 例患者完成 12 个月的随访时，计划进行三次中期安全性分析。
首例患者于 2016 年 6 月入组，截至 2018 年 6 月，已有 340 例患者入组。预计 2019 年将进行二次终点分析，2021 年底将获得 300 例患者的肿瘤学结果。该试验在 CEEGOG（CEEGOG CX-01）、ENGOT（ENGOT-Cx 2）和 ClinicalTrials.gov 数据库（NCT02494063）注册。
