Randomized Trial of Different Surgical Approaches in Patients of Chinese Early-stage Cervical Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This multi-center, randomized controlled study aims to compare the survival outcomes (including overall survival, progression-free survival and disease-free survival between Chinese uterine cervical patients receiving different surgical routes (laparotomy and laparoscopy) for radical hysterectomy or trachelectomy, which is the primary study objective. All patients with uterine cervical cancer of FIGO stage IA1 (with lymphovascular space invasion), IA2 and IB1 will be included and randomized into two groups: laparotomy and laparoscopy groups for radical hysterectomy or trachelectomy. Secondary study objectives include: patterns of recurrence, treatment-associated morbidity (6 months from surgery), cost-effectiveness, pelvic floor function, and quality of life.
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
- Single (Investigator)
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
- •Confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix
- •FIGO stage IA1 (with lymphovascular space invasion), IA2 or IB1
- •Type II or III radical hysterectomy or trachelectomy
- •Performance status of ECOG 0-1
- •Aged 18 years or older
- •Signed an approved informed consents
排除标准
- •Not satisfying any of the inclusion criteria
研究组 & 干预措施
Laparotomic radical hysterectomy
干预措施: Laparotomic radical hysterectomy (Procedure)
Laparotomic radical trachelectomy
干预措施: Laparotomic radical trachelectomy (Procedure)
Laparoscopic radical hysterectomy
干预措施: Laparoscopic radical hysterectomy (Procedure)
Laparoscopic radical trachelectomy
干预措施: Laparoscopic radical trachelectomy (Procedure)
结局指标
主要结局
Progression-free survival
时间窗: Five years
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
次要结局
- Morbidity rate(Six months)
- Overall survival(Five years)
- Disease-free survival(Five years)
研究者
Lei Li
Professor
Peking Union Medical College Hospital
