EUCTR2019-003104-12-NL进行中（未招募）1 期
Treatment of locally advanced VULvar CArcinoma in a Neoadjuvant setting with Carboplatin and Paclitaxel chemotherapy - VULCANize
KI-AV0 个研究点目标入组 51 人开始时间: 2019年11月26日最近更新:
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
- 51
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
- •Woman = 18 years
- •Signed and written informed consent.
- •Histologically confirmed squamous cell vulvar carcinoma
- •World Health Organization performance status of 0-2
- •Adequate hematological function
- •Adequate hepatic function
- •Adequate renal function
- •Negative pregnancy test for woman of childbearing potential
- •measurable disease by physical examination
- •TNM stage T2, any N, M0
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 41
排除标准
- •Vulvar cancer other than squamous cell carcinoma at biopsy
- •Previous radiotherapy of the vulva, groins or pelvis
- •Patients with metastasis limited to the pelvic lymph nodes, who can be primarily operated with curative intent
- •Other diagnosis of malignancy or evidence of other malignancy for 5 years before screening for this study
研究者
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