EUCTR2017-003102-40-NL进行中（未招募）1 期
eo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility - NEOCON-F
KI-AV0 个研究点目标入组 120 人开始时间: 2018年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Stage Ib1 cervical cancer measuring =2 - =4 cm on physical examination and imaging in any direction
- •Histologic type: squamous cell carcinoma (SCC), adeno cell carcinoma (ACC), adeno-squamous cell carcinoma (ASC)
- •Lymph vascular space invasion allowed (LVSI)
- •Age =18 years and = 40 years
- •Wish to preserve fertility
- •Written and signed informed consent
- •Negative serum or urine pregnancy test within 14 days prior to registration, and an effective method of contraception must be used during treatment
- •MRI abdomen and pelvis, chest X-ray must be performed and negative for metastatic disease within 12 weeks of enrolment
- •No metastases on pelvic lymph node dissection
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Other high grade histologies like neuro-endocrine and clearcell carcinoma
- •FIGO stage Ia, Ib1< 2 cm, Ib2, II, III and IV disease
- •Involvement of tumor in uterine corpus on MRI or hysteroscopy if performed
- •Evidence of metastatic disease on imagining (PET/CT/MRI) performed within 12 weeks of enrolment
- •other diagnosis of malignancy or evidence of other malignancy for 5 years before screening for this study (except non-melanoma skin cancer).
研究者
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