Cohort Study for Comparing the Efficacy Between the Standard Treatment and Fusion Ontogenetic Surgery for Gynecologic Cancers (FUSION Trial IV)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- Treatment-free interval
研究概览
简要总结
The purpose of this study is to compare standard treatment and fusion ontogenetic surgery (total mesometrial resection, laterally extended endopelvic resection, peritoneal mesometrial resection) for gynecologic cancer in order to evaluate treatment response, adverse effect and survival.
详细描述
Fujii method and ontogenetic surgery are the surgical method of radical hysterectomy that can preserve pelvic organ function as much as possible.
Fujii method has advantage of preserving pelvic autonomic nerve with radical resection of tissue under parametrium. And ontogenetic surgery has advantage of reducing need of radiation therapy by radical resection of tissue above parametrium.
This study is prospective study for fusion ontogenetic surgery that has the advantage of both Fujji method and ontogenetic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, Age ≥ 20 years
- •Patients with primary, recurrent, or refractory cervical cancer (FIGO stage IB1-IVA), primary, recurrent, or refractory uterine cancer (FIGO stage IA, grade 3, IB-IVA), or gynecologic cancer patients showing pelvic sidewall recurrence.
- •ECOG performance status 0 or 1
- •Extensive surgery might be expected to cure the disease, or expected to relieve severe pelvic pain.
- •Patients who signed an approved informed consent
- •Patients who do not have a treatment option other than surgery.
排除标准
- •Female, Age < 20 years
- •ECOG performance status ≥2
- •Bilateral pelvic sidewall invasion
- •Patients who had undergone radical hysterectomy, trachelectomy, or hysterectomy in case of the primary disease.
- •Patients who refused to sign an informed consent
结局指标
主要结局
Treatment-free interval
时间窗: From date of treatment end until the date of first documented progression or date of death (by any cause, in the absence of disease progression) whichever came first, assessed up to 60 months
The time interval from treatment end date to disease recurrence or progression date
Overall survival
时间窗: From the date of treatment start until death due to any cause, assessed up to 60 months
the time interval from treatment start date to death or end of study date
Treatment-related survival
时间窗: the time interval from treatment start date to death or end of study date assessed up to 60 months
the time interval from treatment start date to death or end of study date (recurrent or refractory disease)
Progression-free survival
时间窗: From date of treatment start until the date of first documented progression or date of death (by any cause, in the absence of disease progression) whichever came first, assessed up to 60 months
The time interval from treatment start date to disease recurrence or progression date
次要结局
- Postoperative complications 2(31 days after the ontogenetic surgery through study completion, an average of 1 year)
- Tumor response(3 weeks after completion of ontogenetic surgery up to 6 weeks)
- Time to normal bladder function(The time from the ontogentic surgery to the time of confirmation or normal bladder function, assessed up to 60 months)
- Neurologic disturbance of low extremity(after the ontogenetic surgery, up to 30 days)
- Pain evaluation(1 day before the ontogenetic surgery, and at the time of discharge after postoperative management of the ontogenetic surgery assessed up to 60 months)
- Postoperative complications 1(after the ontogenetic surgery, up to 30 days)
研究者
Hee Seung Kim
Associate Professor
Seoul National University Hospital