NCT04227249尚未招募不适用
Three-year Recurrence Free Survival in Patients With Ultra-low-risk Endometrial Cancer Who do Not Undergo Lymph Node dissEction
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 153
- 主要终点
- 3 year recurrence free survival
研究概览
简要总结
To verify the safety of omission of lymph node dissection in ultra-low-risk endometrial cancer (KGOG criteria), we examine the survival of women with ultra-low-risk endometrial cancer who do not undergo lymph node dissection
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •endometrioid type
- •anticipated surgery omitting lymph node dissection for endometrial cancer
- •pelvis MRI, CA125 - satisfying KGOG criteria
- •no distant metastasis
- •age 19 or more
排除标准
- •other cancer within 5 yr
- •previous hysterectomy
- •previous therapy for endometrial cancer
结局指标
主要结局
3 year recurrence free survival
时间窗: 3 year since surgery
3 year recurrence free survival
次要结局
- transfusion(surgery visit)
- 5 year recurrence free survival(5 year since surgery)
- hemoglobin decline(surgery visit)
- surgery complication(surgery visit)
- 5 year overall survival(5 year since surgery)
- surgery time(surgery visit)
- change of Gynecologic Cancer Lymphedema Questionnaire - Korean (GCLQ-K) score from baseline(baseline - 5week - 6month - 12month - 18month - 24month - 36month - 48month - 60month)
- change of Female Sexual Function Index (FSFI) score from baseline(baseline - 6month - 12month - 24month - 36month - 48month - 60month)
- change of Functional Assessment of Cancer Therapy - General (FACT G) score from baseline(baseline - 1week - 5week - 3month - 6month)
- length of stay(surgery visit)
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