Upper Vaginectomy Versus Brachytherapy in Patients With Early Stage Endometrial Cancer Treated With Laparoscopic Surgery: a Randomized Controlled Study.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Vaginal cuff recurrences
研究概览
简要总结
Recent findings have suggested that laparoscopic surgery is safe and effective, as well as laparotomic one, for treating patients with early stage endometrial cancer (ESEC). Moreover, our long-term previous data have shown a trend in vaginal cuff recurrence in subjects who underwent laparoscopic approach to ESEC consisting of extrafascial hysterectomy, bilateral salpingo-oophorectomy, pelvic +/- para-aortic nodes dissections, regardless grading or lymphovascular space invasion.
Based on these considerations, the aim of the current protocol-study will be to compare two different strategies for vaginal cuff recurrences prevention in patients affected by ESEC treated with laparoscopic surgery. In particular, upper vaginectomy followed by observation will be compared to post-operative brachytherapy.
详细描述
Women with ESEC scheduled for laparoscopic surgery will be enrolled and randomized in three arms [vaginectomy group (VG), brachytherapy group (BG), and control group (CG)]. All laparoscopic procedures will consist of total hysterectomy, bilateral salpingo-oophorectomy, peritoneal washing, systematic inspection of peritoneal cavity and biopsy of each suspect lesion, and pelvic (and eventual para-aortic) lymphadenectomy. In VG an upper vaginecomy will be added to standard laparoscopic procedures followed by observation, whereas BG will receive post-operative brachytherapy. CG will be treated with standard protocol for management of ESEC according to National Comprehensive Cancer Network (www.nccn.org).
Safety and efficacy data will be recorded in each group for 24 months of follow-up.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Early stage endometrial cancer
排除标准
- •Other pre-malignancies and malignancies
- •Major medical conditions
- •Psychiatric disorders
- •Current or past history of acute or chronic physical illness
- •Premenstrual syndrome (PMS)
- •Current or past (within 6 months from study enrolment) use of drugs influencing cognition, vigilance, and/or mood.
结局指标
主要结局
Vaginal cuff recurrences
时间窗: 24 months
次要结局
- Overall survival(24 months)
- Post-operative complications(six months)
- Adverse events(24 months)
- Loco-regional recurrence rate(24 months)
- Distant recurrence rate(24 months)
- Quality of life(24 months)
研究者
Stefano Palomba
Associate Professor
University Magna Graecia