An International European Retrospective Cohort Observational Study Comparing Laparoscopic or Robotic Radical Hysterectomy Versus Abdominal Radical Hysterectomy in Patients With Stage IB1 (FIGO 2009) Cervical Cancer Operated in 2013-2014
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Disease-free survival at 4.5 years
研究概览
简要总结
SUCCOR study tries to understand the outcomes of European patients with stage IB1 cervical cancer (FIGO 2009)1, that underwent a radical hysterectomy for cervical cancer in 2013-2014 within the ESGO area (European Society of Gynecologic Oncology)
详细描述
SUCCOR study tries to understand the outcomes of European patients with stage IB1 cervical cancer (FIGO 2009) (1), that underwent a radical hysterectomy for cervical cancer in 2013-2014 within the ESGO area.
1.-Pecorelli, S. Revised FIGO staging for carcinoma of the vulva, cervix, and endometrium. Int J Gynaecol Obstet 105, 103-104 (2009).
Investigators want to know if the different surgical approaches may influence patients' survival (DFI and OS). A recent randomized phase III clinical trial, the LACC trial, conducted by Dr. Pedro Ramirez, was recently published in the NEJM.https://www.nejm.org/doi/pdf/10.1056/NEJMoa1806395
The LACC trial ran at 33 centers in 12 countries, including six US centers. The study, randomized women during 2008-2017 who had stage 1A1, 1A2, or 1B1 cervical cancer to either MIS or open surgery for a radical hysterectomy. The study's primary endpoint was disease-free survival at 4.5 years. The results favored significantly open surgery.
Just after this report, the results from a second study by Dr. Jose Alejandro Rauh-Hain, that used observational data from the US National Cancer Database found significantly worse overall survival following minimally invasive radical hysterectomy for early-stage cervical cancer, compared with laparotomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Disease-free survival at 4.5 years
时间窗: From date of surgery for cervical cancer (Radical Hysterectomy) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 84 months
Compare disease-free survival at 4.5 years in patients who underwent a laparoscopic or robotic radical hysterectomy (MIS) vs. abdominal radical hysterectomy (TARH) for stage IB1 cervical cancer.
次要结局
- Overall survival Overall survival at 5 years between groups.(months until the date of first documented date of death from any cause or the date last contact if case patient is alive, assessed up to 84 months)
- Patterns of recurrence(Through study completion, an average of 1 year)
- Rate of surgical complications during the first 30 days after surgery(30 days after surgery)