LACE - Laparoscopic Approach to Cancer of the Endometrium: An International Multicenter Randomized Phase 3 Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 760
- 试验地点
- 42
- 主要终点
- Disease free survival
研究概览
简要总结
The primary objective of this study is to assess disease-free survival at 4.5 years postoperatively for women with apparent Stage 1 endometrial cancer, comparing patients who are randomised to receive Total Laparoscopic Hysterectomy (TLH) and patients who are randomised to receive Total Abdominal Hysterectomy (TAH).
详细描述
This phase III international, multicenter, open-label, randomized clinical trial is an equivalence study with the hypothesis is that Total Laparoscopic Hysterectomy (TLH) is associated with equivalent disease-free survival when compared to the standard treatment of Total Abdominal Hysterectomy (TAH) for women with apparent Stage I endometrial cancer.
The secondary hypotheses are:
- TLH is associated with equivalent or improved Quality of Life (QoL) at 6 months;
- TLH is associated with reduced treatment-related morbidity;
- TLH is associated with shorter hospital stay;
- TLH is associated with less analgesic consumption;
- TLH is cost effective;
- TLH is associated with improved pelvic floor function.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who may be included for this study must have the following:
- •Histologically confirmed primary endometrioid adenocarcinoma of the endometrium;
- •Clinical stage I disease;
- •ECOG Performance status of 0-1;
- •Signed written informed consent;
- •Females, aged 18 years or older.
排除标准
- •Patients will be excluded from participating from the study if they have any of the following:
- •Other histologic type than endometrioid adenocarcinoma of the endometrium;
- •Clinically advanced disease (stages II-IV);
- •Uterine size larger than 10 weeks gestation;
- •Estimated life expectancy of less than 6 months;
- •Enlarged aortic lymph nodes;
- •Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
- •Patient compliance and geographic proximity that does not allow adequate follow-up;
- •Unfit to complete QoL measurements.
研究组 & 干预措施
1
Total Abdominal Hysterectomy
干预措施: Total Abdominal Hysterectomy (Procedure)
2
Total Laparoscopic Hysterectomy
干预措施: Total Laparoscopic Hysterectomy (Procedure)
结局指标
主要结局
Disease free survival
时间窗: 4.5 years from surgery
次要结局
- Intra/Peri/Post-operative and long-term morbidity(30 days from surgery)
- Quality of Life(Measured at baseline, then again 1 week, 6 weeks, 3 months and 6 months postoperatively.)
- Patterns of recurrence(4.5 years from surgery)
- Pain and analgesia(1 week, 1 month, 3 months and 6 months postoperative.)