NCT04291612招募中不适用
SEntinel Lymph Node Endometrial Cancer Trial: A Prospective Multicenter International Single-Arm Observational Trial (SELECT)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,715
- 试验地点
- 38
- 主要终点
- Incidence of pelvic/non-vaginal recurrence at 36 months
研究概览
简要总结
This study is being done to find out how often endometrial cancer recurs after the standard treatment as well as how often the standard treatment results in a lymphedema.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Screening Inclusion Criteria:
- •ECOG performance status 0-1 or KPS ≥ 70%
- •Age ≥ 18 years
- •Endometrioid adenocarcinoma histologic diagnosis on endometrial biopsy or dilatation and curettage
- •No evidence of extrauterine disease, or suspicious pelvic lymph nodes, or distant metastases, or cervical invasion on pre-operative conventional imaging studies (Pelvic +/- Abdomen CT or MRI or sonogram, or body PET scan) and physical examination (uterine confined by exam and imaging )
- •Suitable candidate for surgery
- •Planned surgical treatment including hysterectomy in combination with SLN biopsy and a bilateral salpingo-oophorectomy
- •No history of second primary cancer (invasive or in situ) within the past 5 years, not including non-melanoma skin cancer
- •Approved and signed informed consent
- •No history of neoadjuvant chemotherapy or radiotherapy for endometrial cancer
- •No history of prior pelvic or abdominal radiotherapy
排除标准
- •Extrauterine disease, or gross lymph node involvement, or cervical invasion suspected on pre-operative imaging studies and physical examination (disease not uterine confined clinical stage > I)
- •Contraindication for SLN mapping
- •The planned treatment is not surgery, or the surgical treatment does not include hysterectomy in combination with SLN biopsy and a bilateral salpingo-oophorectomy
- •Eligibility Inclusion Criteria
- •Patients will be classified in the study cohort (part 2; n=182) according to surgical treatment received, final post hysterectomy and staging pathologic report, and planned adjuvant treatment. The inclusion criteria are specified below.
- •Study Cohort (n=182)
- •A patient will be enrolled in the study cohort if all the following criteria are met:
- •At surgery, the patient must undergo:
- •Hysterectomy
- •Bilateral salpingo-oophorectomy, unless already performed (including allowing unilateral salpingo-oophorectomy if unilateral salpingo-oophorectomy already performed)
- •Bilateral pelvic SLN mapping (bilateral sentinel nodes are negative for malignancy)
- •On the final pathologic report, the patient must have a diagnosis of:
- •Stage I intermediate-risk endometrial endometrioid cancer (Grade 1 or Grade 2 with ≥ 50% myometrial invasion or Grade 3 with <50% myometrial invasion, including non-invasive disease)
- •Negative pelvic peritoneal cytology
- •Adjuvant treatment as recommended by the multidisciplinary team must be as follows:
- •No adjuvant treatment, or
- •Intravaginal radiation only
- •Eligibility Exclusion Criteria
- •There is intra-operative detection of extra-uterine disease or grossly involved lymph nodes
- •Presence of any positive pelvic nodes including micrometastasis and isolated tumor cells (ITC)
- •Hysterectomy is not performed
- •Bilateral salpingo-oophorectomy is not performed, unless already performed (unilateral salpingo-oophorectomy is allowed if unilateral salpingo-oophorectomy already performed)
- •Failed unilateral or bilateral SLN mapping
- •Patient undergoes a complete unilateral or bilateral pelvic lymphadenectomy
- •Patient undergoes a radical type C hysterectomy
- •Stage IA endometrioid cancer Grade1 or 2 and myometrial invasion <50%
- •Stage IB Grade 3 endometrioid cancer
- •Non-endometrioid histology: Serous, clear cell, carcinosarcoma, undifferentiated, or de-differentiated histology noted on final hysterectomy pathology
- •Empty unilateral or bilateral sentinel lymph nodal packet(s)
- •Positive peritoneal cytology
研究组 & 干预措施
Part 2
Participants will have undergone surgery and bilateral sentinel lymph node mapping (negative for malignancy)
干预措施: Physical exam (Other)
Part 1
Participants will have endometrioid adenocarcinoma histological diagnosis with planned surgical treatment including hysterectomy in combination with SLN biopsy.
结局指标
主要结局
Incidence of pelvic/non-vaginal recurrence at 36 months
时间窗: 36 months
Participants will be assessed every 6 (+/- 2) months for 36 months through routine physical examination
次要结局
未报告次要终点
研究者
研究点 (38)
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