NCT04970368终止3 期
Randomized Phase 3 Study of Selective Versus Sentinel Node Surgical Staging for the Treatment of Endometrial Cancer
Frederick R. Ueland, M.D.2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2021年11月5日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Recurrence-free survival rate
研究概览
简要总结
This study aims to estimate the recurrence-free survival rates in women with endometrial cancer treated with selective versus sentinel node surgical staging.
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
- •Surgical candidate for complete hysterectomy and bilateral salpingooophorectomy with pelvic and aortic lymphadenectomy
- •Histologically or cytologically confirmed endometrioid-type endometrial cancer confined to the uterine corpus
- •No clinical evidence of extra-uterine disease on pre-operative evaluation.
- •Prior systemic chemotherapy is allowed so long as it was at least five years prior to study enrollment, and there is no evidence of disease after such therapy.
- •Age ≥18 years.
- •Life expectancy (estimated survival) of at least 6 months.
- •AST(SGOT)/ALT(SGPT) < 3.0X upper limit of normal
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •GOG/ECOG Performance Status greater than 2
- •Non-endometrioid cell type
- •Clinical evidence of disease that extends beyond the uterus, including the presence of suspicious aortic or inguinal nodes on imaging or clinical exam
- •Previous vaginal, pelvic or abdominal irradiation
- •Chemotherapy, hormone therapy or immunotherapy directed at the present disease
- •Previous pelvic lymphadenectomy or retroperitoneal surgery
- •Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
- •Known allergy to iodine or indigocyanine green (ICG) tracer, or allergic reactions to compounds of similar chemical or biologic composition
- •Patients with uncontrolled intercurrent illness
- •Patients with psychiatric illness/social situations that would limit compliance with study requirements
- •Pregnant or lactating women
结局指标
主要结局
Recurrence-free survival rate
时间窗: 5 years
Recurrence-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging
次要结局
- Concordance of SELECTIVE and SENTINEL NODE surgical staging with final pathology(5 years)
- Disease-specific survival rate(5 years)
- Patient mortality(5 years)
- Patient morbidity(5 years)
- Progression-free survival rate(5 years)
- Overall patient survival rate(5 years)
研究者
Frederick R. Ueland, M.D.
Professor
University of Kentucky
研究点 (2)
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