NCT06677112招募中不适用
Randomized Phase 3 Study of SELECTIVE SURGICAL STAGING Versus REFLEX Lymphadenectomy in Non-mappers Undergoing Sentinel Lymph Node Sampling for the Treatment of Endometrial Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 625
- 试验地点
- 2
- 主要终点
- Recurrence free survival
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. This study will gather information to help determine the best way to evaluate lymph nodes during surgery for endometrial cancer.
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 carcinoma of the endometrium confined to the uterine corpus
- •No clinical evidence of extra-uterine disease on pre-operative evaluation. Preoperative evaluation to rule-out extra-uterine disease may include a CT scan, MRI or ultrasound. Note: preoperative imaging is not mandatory for study enrollment.
- •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.
- •Neoadjuvant chemotherapy for this endometrial cancer is not allowed.
- •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 Performance Status greater than 2 (Appendix II)
- •Uterine sarcoma
- •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 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 should be excluded
- •Known allergy to iodine or indocyanine 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. Women of child-bearing potential will be excluded if they have a positive serum/urine pregnancy test
结局指标
主要结局
Recurrence free survival
时间窗: up to 5 years
Participants with no measurable disease from study entry until disease recurrence, death, or date of the last contact
次要结局
- Concordance between selective surgical staging and final pathology Incidence(5 years)
- Progression-free survival(up to 5 years)
- Disease-specific Survival(up to 5 years)
- Overall patient survival rate(5 years)
研究者
研究点 (2)
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