Systematic Lymphadenectomy During Interval Debulking Surgery in Advanced Epithelial Ovarian Cancer: a Multicenter Real-world Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,090
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
The study aims to investigate the prognostic and postoperative complication relevance of lymphadenectomy in advanced epithelial ovarian cancer patients who received neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS). The main question it aims to answer is:
Does systematic lymphadenectomy during interval debulking surgery have a significant impact on survival in patients with advanced epithelial ovarian cancer who have received neoadjuvant chemotherapy?
The progression-free survival (PFS), overall survival (OS), and postoperative complication were compared between the lymphadenectomy and no lymphadenectomy groups to answer the question.
详细描述
The study aims to investigate the prognostic and postoperative complication relevance of lymphadenectomy in advanced epithelial ovarian cancer patients who received neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS). The study included patients with histologically confirmed advanced epithelial ovarian cancer who received IDS at seven tertiary hospitals in China from 2006 to 2021. The progression-free survival (PFS), overall survival (OS), and postoperative complication were compared between the lymphadenectomy and no lymphadenectomy groups. Propensity score matching (PSM) and overlapping weight (OW) analyses were performed to minimize selection bias.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients with advanced epithelial ovarian cancer (stage IIB-IV, according to the International Federation of Gynecology and Obstetrics (FIGO) 2014);
- •Patients who underwent NACT followed by IDS.
排除标准
- •Patients with early-stage ovarian cancer (FIGO stage I-IIA);
- •Patients only receiving primary debulking surgery (PDS) as initial treatment without NACT;
- •Histological subtypes other than advanced epithelial ovarian cancer;
- •Patients with unclear sites of lymphadenectomy and non-compliant systematic lymphadenectomy that not include pelvic and/or para-aortic lymph nodes.
结局指标
主要结局
Progression free survival (PFS)
时间窗: From the initial diagnosis to the occurrence of recurrence, progression, death, or the latest follow-up, whichever came first, until February 10, 2021, an average of 3 years
The progression-free survival (PFS) was defined as the duration from the initial diagnosis to the occurrence of recurrence, progression, death, or the latest follow-up, whichever came first.
Overall survival (OS)
时间窗: From the initial diagnosis to the occurrence of recurrence, progression, death, or the latest follow-up, whichever came first, until February 10, 2021, an average of 5 years
Overall survival (OS) was described as the duration from the date of diagnosis to the date of death from any cause or the last follow-up date.
次要结局
未报告次要终点