2023-505991-31-00已完成3 期
BIOMarkers in Endometrial Cancer - A phase III open label randomized trial to determine the efficacy of biomarker staging as compared to conventional staging in women with presumed early-stage endometrial cancer (The BIOMEC trial)
Karolinska University Hospital4 个研究点 分布在 1 个国家目标入组 1,037 人开始时间: 2023年9月29日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,037
- 试验地点
- 4
- 主要终点
- Overall survival
研究概览
简要总结
To investigate the non-inferiority of biomarker staging to select women with presumed early-stage endometrial cancer to adjuvant treatment
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed primary carcinoma in the endometrium
- •Women able to understand and comply with planned study procedures
- •Women with presumed FIGO stage I-II
- •Planned surgery with curative intent
- •Patient must be suitable candidates for surgery
- •Patient must be suitable candidates for adjuvant treatment
- •ECOG performance status 0-2
- •Patients who have signed an approved Informed Consent
- •Age ≥ 18 years
- •Subject has adequate organ function, defined as follows: Haemoglobin ≥9.0 g/dL Absolute neutrophil count (ANC) ≥1500/μL Platelets ≥100 000/μL Creatinine ≤1.5 × ULN AST and ALT ≤2.5 x ULN
排除标准
- •FIGO stage > II pre- or peroperatively
- •FIGO stage IIIA or IIIB or IV at final pathology
- •Women with a history of pelvic or abdominal radiotherapy
- •Women who are pregnant
- •Women in whom surgery with palliative intent only is planned
- •Women with secondary invasive neoplasm in the last 5 years (except non-melanoma skin cancer, breast cancer T1 N0 M0 grade 1 or 2 without any signs of recurrence or activity
- •Women with iodine allergy cannot participate in the sentinel node part of the trial
- •Women in whom macroscopic dissemination is suspected at preoperative imaging
- •Women in whom macroscopic dissemination is confirmed during surgery
结局指标
主要结局
Overall survival
Overall survival
次要结局
- LYMQOL and volume measurement, lymphosintigraphy result
- Clinical Frailty Scale-9 score (1-9)
- As measured by CT and applicable software (e.g., Coreslicer, Slice-o-matic etc.)
- QALY, cost per patient
- 30-day post-operative complications and adverse events
- Recurrence-free survival
- EORTC QLQ-C30, QLQ-EN24 and EQ5D-5L Score
研究者
Sahar Salehi
Scientific
Karolinska University Hospital
研究点 (4)
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