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临床试验/NCT03739944
NCT03739944Unknown3 期

Randomized Trial of Different Surgical Approaches in Patients of Chinese Early-stage Cervical Cancer

Lei Li1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2018年11月23日最近更新:
适应症
干预措施

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

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

Active Comparator

干预措施: Laparotomic radical hysterectomy (Procedure)

Laparotomic radical trachelectomy

Active Comparator

干预措施: Laparotomic radical trachelectomy (Procedure)

Laparoscopic radical hysterectomy

Active Comparator

干预措施: Laparoscopic radical hysterectomy (Procedure)

Laparoscopic radical trachelectomy

Active Comparator

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

发起方
Lei Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lei Li

Professor

Peking Union Medical College Hospital

研究点 (1)

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